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CTRI Number  CTRI/2025/10/096041 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 14/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Bathing Difficulties in Women with Upper Extremity Injury 
Scientific Title of Study   Exploring Bathing Difficulties in Women with Upper Extremity Injury: A Qualitative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyothirmayi P 
Designation  Postgraduate Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  6238911940  
Fax    
Email  jyothirmayi.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Shovan Saha 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880059426  
Fax    
Email  shovan.saha@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Shovan Saha 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880059426  
Fax    
Email  shovan.saha@learner.manipal.edu  
 
Source of Monetary or Material Support  
Katurba Hospital, Manipal Academy of Higher Education, Manipal- 576104 
 
Primary Sponsor  
Name  Jyothirmayi P 
Address  Department of Occupational Therapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka 
Type of Sponsor  Other [(SELF)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shovan Saha  Kasturba Hospital, Manipal  Department of Occupational Therapy, Kasturba Hospital, Manipal, Udupi, Karnataka, 576104
Udupi
KARNATAKA 		 9880059426

shovan.saha@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2 (Student Research)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M752||Bicipital tendinitis, (2) ICD-10 Condition: M751||Rotator cuff tear or rupture, notspecified as traumatic, (3) ICD-10 Condition: M701||Bursitis of hand, (4) ICD-10 Condition: M703||Other bursitis of elbow, (5) ICD-10 Condition: M799||Soft tissue disorder, unspecified, (6) ICD-10 Condition: M258||Other specified joint disorders, (7) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (8) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Female 
Details  1. Women who have completed 4 weeks of non-surgical management
2. Women who are 8 weeks post-operative for upper extremity injury
3. Women reported with difficulty in bathing
4. Women who can speak and understand English or Malayalam or Hindi or Kannada
5. Women aged 18 to 64 years 
 
ExclusionCriteria 
Details  1. Women with injury to both arms
2. Women with nerve injury
3. Women with stroke
4. Women with rheumatoid arthritis and osteoarthritis
5. Women with burns 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To explore bathing difficulties experienced by women with upper extremity injury using in-depth interview  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Aim: To explore bathing difficulties experienced by women with upper extremity using in-depth interview. 

Justification for the study: Bathing is considered one of the most important activities of daily living involving complex movements of the upper extremity. An injury to the upper extremity limits its movements, thus affecting the performance of bathing, impacting the overall well-being of an individual. The perception of gender affects and influences bathing difficulties with a certain level of discomfort, especially among women, which is not well captured. There is a limited study addressing bathing difficulties experienced by women due to upper extremity injuries, with no study conducted in the Indian context addressing the difficulties experienced by women with upper extremity injury. Therefore, it is important to explore the experiences of women with upper extremity injury to provide client-specific interventions and enhance overall well-being. 
.

Detailed description of procedure: The proposal is presented and approved by the Institutional Research Committee (IRC). Permission from the Medical Superintendent of Kasturba Hospital is obtained for the recruitment of participants. An interview guide is developed and validated by subject experts. Permission from the Institutional Ethics Committee (IEC) is obtained, and CTRI registration will be done. Sample screening and selection of participants will be done. An overall briefing of the study will be provided to the participants who fall within the eligibility criteria. A total of 10 to 12 participants will be recruited based on the eligibility criteria. A participant information sheet, followed by informed consent, will be obtained from the participants. The anonymity of the participants will be safeguarded by the researcher. The participants will be informed of the place and time of the interview based on their convenience, via email or telephone. An in-depth face-to-face semi-structured interview will be conducted with only the participant and the researcher in the Occupational Therapy Department in Kasturba Hospital, Manipal. The time taken for the interview will be 30-45 minutes and will be audio recorded for study purposes. The study will be concluded when no new information is obtained from the participants. The researcher will safeguard all data obtained, and any new information and study information will be available to the participant on inquiry. 

Data Analysis: The data obtained from interviews will be transcribed verbatim in English or Malayalam or Hindi or Kannada, and translated to English. The transcripts will be read and re-read to understand, and then initial codes will be generated from the data obtained. The codes will then be grouped, giving rise to potential themes which will be reviewed, and the results will be reported with the themes obtained (Braun & Clarke, 2006).
 
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