JMIR Research Protocols

Unilateral Le Fort I Advancement Versus Dentoalveolar Transport Distraction in Patients With Large Alveolar Clefts: Protocol for a Prospective Observational Study

2026-08-25T12:30:13-04:00

Background: Cleft lip and palate is a complex congenital defect that can present functional and esthetic challenges, particularly in patients with large alveolar clefts for which surgical management is indicated. In contrast to traditional treatment techniques such as autologous bone grafting, newer techniques include unilateral Le Fort I osteotomy advancement and dentoalveolar transport distraction osteogenesis and have been shown to be useful in the treatment of maxillary hypoplasia and large alveolar clefts. These techniques may help improve both esthetic and function in patients with substantial tissue deficiencies as well as in patients with scarring. Objective: This study aims to compare the outcomes of unilateral Le Fort I advancement and dentoalveolar transport distraction in the management of large alveolar clefts, specifically focusing on the closure of alveolar gaps, maxillary arch form, stability of the advanced or distracted segment, and wound healing. Methods: This prospective observational study is being conducted at the Department of Oral and Maxillofacial Surgery, Siddharth Gupta Memorial Cancer Hospital, in collaboration with the Sharad Pawar Dental College in Maharashtra, India. Patients aged 9 to 25 years with unilateral alveolar clefts measuring 1 cm or greater will be included. Patients with smaller clefts, bilateral clefts, or those who are unsuitable for surgery will be excluded. The study will evaluate 14 patients, divided into 2 groups: group A will undergo dentoalveolar transport distraction, whereas group B will undergo unilateral Le Fort I advancement. We will assess the closure of the alveolar gap, arch form, stability of the advanced or distracted segment, and soft tissue healing. Through cone beam computed tomography and maxillary occlusal view, radiographic parameters of closure of the alveolar gap and arch form will be evaluated. The outcome measures will be statistically analyzed on RStudio software, with appropriate tests applied to each outcome measure. <.05 will be considered significant. Results: As of June 2025, institutional ethical clearance has been obtained and patient recruitment is ongoing. Recruitment began in April 2023, with 12 patients enrolled as of June 2025. Data collection is expected to be completed by December 2025, and results will be published in mid-2026. Conclusions: This study aims to provide evidence-based guidance for the management of large alveolar clefts by comparing 2 graftless surgical techniques: unilateral Le Fort I advancement and dentoalveolar transport distraction. The findings are expected to help clinicians select the most suitable surgical approach based on individual case requirements, cleft morphology, and long-term outcome expectations. Ultimately, the study will contribute to optimizing cleft care strategies with reduced donor site morbidity and improved postoperative stability. International Registered Report Identifier (IRRID): DERR1-10.2196/77210

One-Session Versus Three-Sessions of Virtual Reality Exposure Therapy for Public Speaking Anxiety: Protocol of a Randomized Controlled Trial

2026-08-25T12:15:10-04:00

Background: A 1-session virtual reality (VR) exposure for public speaking anxiety has been found to be effective in reducing public speaking anxiety. Previous meta-analyses comparing 1-session to several sessions of in vivo exposure for specific phobias did not find a difference in effectiveness. However, due to the specificity of VR exposure and public speaking anxiety, it is unclear how dividing the same amount of exposure tasks into 3 shorter sessions instead of one long session would affect the effectiveness of VR exposure for public speaking. Objective: The aim of this study is to compare the efficacy of a VR exposure-based intervention for public speaking anxiety and the level of VR presence between a 1-session treatment and an equal exposure time divided into 3 sessions, followed by 4 weeks of online intervention in both groups. Methods: This randomized controlled trial will aim to recruit 86 higher education students experiencing high levels of public speaking anxiety, who will be randomized into one of two conditions: either 1 or 3 sessions of VR exposure therapy, with the same total number of exposure exercises. Both conditions will be followed by the same 4-week online program to encourage in vivo exposure tasks for both conditions. The study will be an exploratory superiority trial testing whether one of the conditions is superior to the other. The primary outcome will be the Public Speaking Anxiety Scale. Assessments will take place pretreatment, at the beginning of the face-to-face session, during the face-to-face session, 1 week after the last VR exposure session, at the end of 4 weeks of the online program, and at two follow-ups at 3 and 12 months after finishing the online program, or equivalent time if the online program was discontinued. Repeated measures within-between ANOVA, the reliable change index (RCI), and effect sizes will be used as statistical analyses, and intention-to-treat will be the primary analysis approach; additional per-protocol analysis will be reported. Results: The study received funding from the Research Council of Lithuania (LMTLT) in April 2023. Recruitment for the study officially started in January 2024 and was still ongoing during the submission of this paper in December 2025. As of November 2025, a total of 101 participants have completed the initial screening. The final results of the study are expected to be prepared and submitted for publication in March 2026. Conclusions: This is the protocol of a study that will explore an understudied and clinically important question that could generate preliminary evidence comparing 1-session versus 3-session VR exposure for public speaking and inform further research. However, given the small and specific sample, results would have to be confirmed in larger and more diverse samples. Trial Registration: ClinicalTrials.gov NCT06214039; https://clinicaltrials.gov/study/NCT06214039 International Registered Report Identifier (IRRID): DERR1-10.2196/89612

Empowered Relief vs Cognitive Behavioral Therapy for Patients With Systemic Lupus Erythematosus and Chronic Pain: Study Protocol for a National, Randomized, Noninferiority Trial

2026-08-25T12:00:03-04:00

Background: Systemic lupus erythematosus (SLE) presents substantial life challenges, reflecting the complex and heterogeneous nature of the disease. Pain is common and often one of the earliest manifestations. Skill-based behavioral pain treatments are often inaccessible to patients with SLE, and no SLE-specific evidence exists to guide patient and clinician treatment choices. To fill a pressing evidence gap for SLE pain treatment, the Lupus PROGRESS (Pain Relief With Online Groups That Empower Skill-Based Symptom Reduction) trial will compare a lower-burden evidence-based behavioral pain treatment with online multisession cognitive behavioral therapy (CBT; the gold standard behavioral treatment for chronic pain) while also enhancing diversity and representativeness among patient advisors and study participants. Objective: Lupus PROGRESS is a national, pragmatic, randomized noninferiority trial comparing the effectiveness of 2 evidence-based behavioral pain treatments (online 8-session CBT vs 1 session the Empowered Relief program; Stanford University) in adults with SLE and chronic pain in the United States for reducing pain intensity and pain interference at 3 months after treatment (multiple primary end points). Methods: In total, 150 adults with SLE and pain (≥3 months, intensity of ≥3/10) will be enrolled from academic medicine, community health network, and insurance payer study sites. Participants are randomized 1:1 to either 1-session Empowered Relief or 8-session CBT, with both treatments delivered online to groups. Mixed-model repeated measures and intention-to-treat analytic approaches will be used to test comparative effectiveness aims from baseline to 3 months after treatment (the primary end point). Multiple primary outcomes are pain intensity and pain interference; priority secondary outcomes are sleep disturbance, pain catastrophizing, pain bothersomeness, and anxiety; and other secondary outcomes are satisfaction with roles and responsibilities and global impression of change, anger, fatigue, and depression. Durability of effects will be tested at 6 months after treatment. Empowered Relief is hypothesized to have superior treatment completion and adherence and lower treatment burden ratings than CBT. In exploratory analyses, we will compare health care use through medical record and claims data 3 months prior to enrollment to the last 3 study months, hypothesizing reduced noninferiority in reduced use. The study also incorporates a multilevel patient engagement infrastructure to improve accessibility, recruitment, and study relevance. Results: As of May 2026, we have enrolled 130 participants. Enrollment is anticipated to end in November 2026, with treatments completed by April 2027 and full analyses completed by February 2028. Conclusions: Lupus PROGRESS will provide real-world pragmatic evidence on whether a 1-session online group skill-based treatment is noninferior to 8-session CBT. Results from this patient-centered study will inform more accessible, equitable, and patient-centered chronic pain care for people living with lupus. Trial Registration: ClinicalTrials.gov NCT05612750; https://clinicaltrials.gov/study/NCT05612750

Psychological Factors and Personality Traits Influencing the Experience and Perception of Pain in Women Undergoing Mammography: Protocol for a Cross-Sectional Study

2026-08-25T10:00:16-04:00

Background: Breast cancer screening through mammography is essential for early detection and improved survival; however, pain and discomfort during the procedure remain major barriers to women’s participation. Pain perception during mammography is influenced not only by technical factors but also by psychological variables such as anxiety, depression, pain catastrophizing, and personality traits. Despite growing evidence, findings on the role of psychological factors remain inconsistent, and the contribution of personality traits remains largely unexplored, highlighting the need for further investigation. Objective: This study aims to investigate associations among psychological factors (anxiety, depression, and pain catastrophizing), Ten-Item Personality Inventory personality traits, and pain perception and experience in women undergoing routine mammography at public and private radiology centers in Cyprus. The study hypothesizes that higher anxiety levels and first-time mammography experience are associated with greater perceived pain during mammography. Methods: This cross-sectional study will include approximately 380 women aged 35 to 75 years undergoing routine screening mammography at public and private radiology centers in Cyprus. Participants will complete the Patient Health Questionnaire-4, the Pain Catastrophizing Scale, the Ten-Item Personality Inventory, and a demographic and clinical questionnaire before the examination. The primary outcome will be perceived pain intensity during mammography, assessed immediately after the examination using a Visual Analog Scale. Psychological factors, including anxiety, depression, pain catastrophizing, and personality traits, will be evaluated as the main independent variables. Secondary analyses will examine the role of demographic and clinical characteristics, as well as previous mammography experience, in pain perception. Descriptive statistics will summarize participant characteristics, and associations between study variables and pain intensity will be examined using Pearson or Spearman correlation analyses and hierarchical multiple linear regression models adjusted for relevant confounders. The study will be conducted and reported in accordance with the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for observational studies. Results: Participant recruitment and data collection began in March 2026. By June 2026, 50 women had been enrolled in the study. Recruitment and data collection are expected to continue through September 2026. Data analysis is anticipated to be completed by December 2026, with dissemination of findings and manuscript submission planned for 2027. Following study initiation, the study setting was expanded to include a public radiology center to facilitate recruitment and enhance sample representativeness. Conclusions: If the study findings support the proposed associations, early identification and management of psychological factors related to pain perception during mammography may improve women’s overall experience, enhance comfort during the procedure, and potentially increase adherence to breast cancer screening programs. International Registered Report Identifier (IRRID): PRR1-10.2196/92804

Efficacy of Corticosteroid Therapy on Neurological Outcomes in Near-Hanging Patients With Altered Sensorium: Protocol for a Multicenter, Double-Blinded, Placebo-Controlled, Randomized Trial (CHANGING Trial)

2026-08-25T09:00:18-04:00

Background: In India, hanging is the leading method of suicide, and survivors of near-hanging often present with altered sensorium due to cerebral edema from cervical vascular compression and hypoxia. Management typically involves supportive care and antiedema measures, such as mannitol, hypertonic saline, and dexamethasone. Dexamethasone, a corticosteroid that crosses the blood-brain barrier, is commonly used for presumed cerebral edema. However, evidence supporting its efficacy is limited, and there are no clinical guidelines that recommend its routine use. A randomized controlled trial is therefore essential to establish the real-world efficacy of dexamethasone in this setting. Objective: The primary objective of this study is to evaluate the efficacy of intravenous dexamethasone, compared with placebo, in achieving good neurological outcomes at day 28. Secondary objectives are to assess the efficacy of dexamethasone, compared with placebo, in improving neurological outcomes at hospital discharge. We will also compare the duration of hospital stay and the incidence of in-hospital complications between patients receiving dexamethasone and those receiving a placebo. Methods: The CHANGING trial (Corticosteroids in HANGING) is a multicenter, double-blind, randomized, placebo-controlled study at 3 Indian tertiary centers. It enrolls 192 near-hanging patients with a Glasgow Coma Scale score ≤13 over 3 years, randomizing them in a 1:1 ratio to IV dexamethasone or placebo, plus standard care for 3 to 5 days. The primary outcome is neurological recovery at day 28, assessed using the Glasgow Outcome Scale. Secondary outcomes include the Glasgow Outcome Scale at discharge, duration of hospital stay, and the incidence of in-hospital complications. This trial has been approved by Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry Institute Ethics Committee (January 22, 2025), with subsequent approvals from Indira Gandhi Medical College and Research Institute (April 8, 2025) and Postgraduate Institute of Medical Education and Research (August 26, 2025). Results: The study commenced in October 2025 and is planned to be completed by May 2028. It is currently ongoing, and patient recruitment is in progress. Results will be analyzed after completion of enrollment and follow-up and will be disseminated through peer-reviewed publications. Conclusions: Corticosteroids are widely used for cerebral edema after near-hanging, but their role is unclear. The CHANGING trial will test dexamethasone’s efficacy and safety in these patients to guide future practice and guidelines. Trial Registration: Clinical Trials Registry India CTRI/2025/02/081343; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTI0MzI1&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/100623

Prediction of Pregnancy Complications Related to Placental Dysfunction: Protocol for a Prospective Cohort Study (Placental Health Study)

2026-08-25T09:00:18-04:00

Background: Placental dysfunction underlies major obstetric complications, including preeclampsia, fetal growth restriction, preterm birth, and stillbirth. While early identification of pregnancies at high risk of complications enables preventive interventions, current screening methods based on traditional risk factors have limited accuracy. Objective: This study aims to develop robust prediction models for placental dysfunction–related pregnancy disorders across 3 gestational windows and to determine the optimal delivery time by integrating maternal characteristics, biophysical measurements, and maternal circulating biomarkers. Methods: The Placental Health Study is a prospective cohort study conducted at the Maternal Fetal Medicine Unit at Gold Coast University Hospital, Australia. Singleton pregnancies are enrolled at 11 to 13 weeks, 26 to 28 weeks, and 35 to 36 weeks of gestation and are followed until delivery. Exclusion criteria are multiple pregnancies, major fetal anomalies, maternal age below 18 years, and inability to provide informed consent. Clinical data, standardized ultrasound and Doppler measurements, hemodynamic parameters, and biospecimens (serum, plasma, whole blood RNA, and urine) are collected at each visit. Three gestational age-specific datasets (11‐13 weeks, 26‐28 weeks, and 35‐36 weeks) will be constructed for model development. Prediction models will be developed using multivariable logistic regression. Competing risks (Fine and Gray) models will be used as sensitivity analyses for outcomes related to gestational age at delivery. Bayesian updating will be applied to refine existing Fetal Medicine Foundation risk estimates using additional biomarkers or variables collected later in pregnancy. Developed models will undergo internal validation via 5-fold cross-validation, with performance assessed through model discrimination, calibration, and comparison against existing approaches. Collected biospecimens will also be analyzed for angiogenic markers and exploratory omics studies. Results: Recruitment occurred from June 2022 to February 2026, enrolling 1267 participants. As of submission, 1072 (84.6%) participants have completed their pregnancies, 144 (11.4%) participants remain active in follow-up, and 51 (4%) were withdrawn or had missing or duplicated data. Clinical data have undergone preliminary cleaning and descriptive analysis. Biospecimens are being processed for biomarker quantification and exploratory molecular analyses. Two to three publications are anticipated in late 2026 or early 2027. Conclusions: This cohort establishes a comprehensive database and biospecimen repository to advance prediction of placental dysfunction–related complications. Three-stage recruitment integrated into routine clinical care enhances feasibility and translation potential, enabling dynamic risk assessment and investigation of temporal biomarker changes. Although the single-center design may limit generalizability, warranting future external validation, the interdisciplinary research team brings diverse expertise that strengthens study depth and scope. International Registered Report Identifier (IRRID): DERR1-10.2196/95231

Validation of Wound Assessment Instruments Across Brazilian Clinical Contexts: Protocol for a Scoping Review

2026-08-24T16:45:11-04:00

Background: Wounds are common and clinically consequential, and consistent assessment is essential for communication, monitoring, and decision-making. Although multiple wound assessment instruments exist, there is no agreement among specialists on which criteria to prioritize during validation processes and evidence synthesis remains insufficient within the Brazilian context. Objective: This scoping review aims to map which aspects of wound assessment instruments are considered important by expert health professionals when validating these instruments in the Brazilian context across clinical care settings. Methods: The review will be conducted in accordance with JBI guidance for scoping reviews. A 3-step search strategy will be used on the MEDLINE (PubMed), Embase, Scopus, Web of Science, and Cochrane Library databases, as well as in the LILACS, SciELO, and BDENF (Base de Dados em Enfermagem) databases, supplemented by gray literature sources (Brazilian Digital Library of Theses and Dissertations, CAPES Theses Catalog, and Google Scholar) and reference list screening. Records will be deduplicated and screened by 2 independent reviewers, with reporting aligned to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Data will be extracted using a piloted extraction tool and synthesized descriptively in tables and with narrative mapping. Critical appraisal will not be performed. Results: This protocol was registered with the Open Science Framework on February 6, 2026. Database searches are scheduled to commence following protocol publication. Data collection is projected to begin in July 2026, with screening and data extraction expected to be completed by December 2026, and the final review report planned to be submitted for publication in the first quarter of 2027. Results will map the extent, nature, and distribution of evidence on expert-led validation of Brazilian wound assessment instruments across clinical settings. Conclusions: This scoping review will provide a systematic and transparent synthesis of which aspects health professionals consider when validating Brazilian national wound assessment instruments. We expect the findings to identify methodological gaps, inform future validation studies, and support the development and refinement of nationally applicable instruments across diverse Brazilian health care contexts. Trial Registration: OSF Registries 3FSTE; https://osf.io/3FSTE/overview International Registered Report Identifier (IRRID): PRR1-10.2196/99483

Efficacy of Mulligan Mobilization, Maitland Mobilization, High-Velocity Thrust, and Muscle Energy Technique for Pain, Disability, and Center-of-Gravity Displacement in Patients With Sacroiliac Joint Dysfunction: Protocol for a Randomized Controlled Trial

2026-08-21T15:45:03-04:00

Background: Sacroiliac joint (SIJ) dysfunction is associated with significant pain, disability, and altered postural control in adults. Manual therapies, including Mulligan mobilization, Maitland mobilization, high-velocity thrust (HVT), and muscle energy technique (MET), are routinely applied for the management of SIJ dysfunction. However, comparative evidence regarding their effects on pain, disability, and center-of-gravity (COG) displacement remains insufficient. Objective: This study aims to compare the efficacy of Mulligan mobilization, Maitland mobilization, HVT, and MET in improving pain, functional disability, and COG displacement in individuals with SIJ dysfunction. Methods: A randomized controlled, parallel-group trial will be conducted on participants diagnosed with unilateral SIJ dysfunction. Participants will be assigned in equal numbers to 4 groups, each receiving Mulligan mobilization, Maitland mobilization, HVT, or MET interventions administered 5 days per week for 3 weeks, in addition to a standardized exercise regimen. The primary outcomes will be pain (assessed using a visual analog scale [VAS]) and functional disability (assessed using the Modified Oswestry Disability Index [MODI]), and the secondary outcome will be COG displacement (measured by sway velocity, lift-up index on the left and right, COG alignment, movement time, and impact index). Results: We hypothesize that all interventions will lead to statistically significant reductions in pain and disability. Results will be analyzed after the completion of the study. Conclusions: This protocol is designed to provide robust comparative data on manual therapy approaches for SIJ dysfunction. Findings may guide physiotherapy practice by informing evidence-based recommendations for optimal management strategies. Trial Registration: Clinical Trials Registry—India CTRI/2025/08/093085; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTM4MjIw&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/87715

Mental Health, Gender Dysphoria, and Quality of Life in Trans Individuals Following Top Surgery: Protocol for a Prospective Cohort Study

2026-08-21T15:45:03-04:00

Background: Top surgery refers to various gender-affirming surgical procedures involving breast or chest tissue. Existing research suggests top surgery improves physical, psychological, and social well-being in transgender and gender-diverse individuals (herein “trans”) who desire it. However, most studies have been retrospective, have not used validated outcome measures, and have excluded nonbinary individuals, limiting the robustness of the existing research. Objective: This study aims to examine changes in mental health, gender dysphoria, risky behaviors, and quality of life of trans people (including nonbinary individuals) following top surgery. Methods: Trans individuals aged 16 years and older undergoing top surgery will be recruited from a single surgeon’s office in Perth, Western Australia, as part of a longitudinal, prospective cohort study. Questionnaires will be administered to participants at 3 time points: within 8 weeks prior to surgery, 6‐8 weeks post surgery, and 1 year post surgery. These questionnaires will collect data on patient demographics, planning and expectations for surgery, support received during surgery access, satisfaction with care received from their surgeon, use of gender-affirming hormones, mental health (ie, anxiety, depression, self-harm and suicide, and mental health diagnoses), gender euphoria and dysphoria, exercise and diet, disordered eating, quality of life, substance use, social acceptance and discrimination, and reflections on the experience and outcomes of their surgery. Patient-reported outcomes will be measured using validated instruments and bespoke items developed through community consultation. Validated instruments include the GENDER-Q (health professional subscale); the Generalized Anxiety Disorder 7-item; the Patient Health Questionnaire-9; the Gender Euphoria Scale; an adapted version of the Olson-Kennedy Chest Dysphoria Scale; the International Physical Activity Questionnaire - Short Form; the Eating Disorder Examination Questionnaire - Short; the Assessment of Quality of Life 8 Dimensions; and the Alcohol, Smoking, and Substance Involvement Screening Test - Short Form. Surgical satisfaction will be assessed using both patient- and surgeon-reported measures, enabling between-group comparisons. Quantitative data will be analyzed using linear regression models and repeated-measures ANOVA to compare outcomes across the 3 time points; qualitative data will undergo a general inductive approach to analysis to produce categories that contextualize and supplement the quantitative findings, as well as identify any novel or unexpected experiences. Results: This study received funding in February 2024. Data collection commenced in May 2025 and is expected to be completed by December 2027. As of February 2026, 26 people have consented to participate. Conclusions: This study will extend research on the mental health, gender dysphoria, and quality-of-life outcomes of top surgery for trans individuals in Australia. By addressing limitations of existing research, this study aims to improve our understanding of trans people’s experience accessing and receiving top surgery. The findings may guide improvements in perioperative and postoperative care and support for patients and inform policy related to gender-affirming surgeries in Australia. International Registered Report Identifier (IRRID): DERR1-10.2196/83928

A Coordinated Approach to Perioperative Rehabilitation to Enhance Outcomes in Melanoma: Protocol for the CARE-Melanoma Pilot Randomized Controlled Trial

2026-08-21T14:30:03-04:00

Background: Rehabilitation is beneficial for individuals with cancer across all phases of care, but access remains limited for many survivors, including individuals with melanoma. As new treatment strategies for melanoma are introduced, there is an opportunity to assess perioperative rehabilitation strategies for patients undergoing surgery during and after neoadjuvant treatment. Objective: This paper describes the protocol for a 2-armed pilot randomized controlled trial with the overall objective of determining the feasibility and preliminary effects of a perioperative rehabilitation strategy for individuals with melanoma at a single cancer institution in Ontario, Canada. Methods: In total, 30 participants, including English-speaking adults with a current melanoma diagnosis scheduled to undergo surgery after neoadjuvant immunotherapy, will be randomized 1:1 to either the intervention or control group. The intervention will include 4 perioperative intervention sessions (2 sessions before surgery and 2 sessions after surgery) led by a trained physiotherapist or kinesiologist. Participants in the intervention group will receive education on the benefits of exercise; how to exercise safely; and rehabilitation techniques to maximize range of motion, strength, and function. Participants will also receive a tailored exercise program and will establish goals and action plans at each session. The control group will receive usual care (no rehabilitation). The primary outcome is feasibility (measured via recruitment, retention, and adherence rates). Secondary outcomes will be collected before and after the intervention and include overall impairment score (measured via the Edmonton Symptom Assessment Scale), physical activity level (Godin Leisure Time Exercise Questionnaire), functional mobility (6-minute walk test and 30-second sit-to-stand test), range of motion (goniometry), grip strength (handheld dynamometry), quality of life (Functional Assessment of Cancer Therapy-Melanoma), perception of health status (EQ-5D-3L), and medication use. Feasibility will be analyzed using descriptive statistics (mean [SDs] or frequency [%]), as appropriate. Secondary outcomes will be reported using means, SD, and CIs of outcomes. Cohen d effect sizes will be calculated and reported for each secondary outcome to inform a future full-scale trial. STATA/MP (version 14) will be used for all statistical analysis, with significance set at P<.05. Results: Trial enrollment began in June 2026, and 3 participants have been recruited to date. Recruitment is expected to be completed by December 2026. Results will be submitted for publication by mid or late 2027. Conclusions: This pilot trial aims to address the evidence gap on the feasibility and preliminary effects of rehabilitation for individuals with melanoma, laying the groundwork for a larger randomized controlled trial and future implementation of rehabilitation for this population. By implementing rehabilitation around the surgical phase, we aspire to enhance patient outcomes by maximizing function and reducing side effects, facilitating a faster return to meaningful daily activities. Trial Registration: ClinicalTrials.gov NCT07320222; https://clinicaltrials.gov/study/NCT07320222