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CTRI Number  CTRI/2023/08/056019 [Registered on: 02/08/2023] Trial Registered Prospectively
Last Modified On: 31/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Music]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of musical therapy on pain and anxiety symptoms in post-surgical cancer patients  
Scientific Title of Study   Efficacy of music therapy on pain and anxiety symptoms in post-surgical cancer patients: A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Rajeev Ranjan 
Designation  Assistant Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA 
Address  Department of Psychiatry AIIMS PATNA Phulwari Shariff Patna Bihar-801507

Patna
BIHAR
801507
India 
Phone  9717531800  
Fax    
Email  rajeevranjan0087@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rajeev Ranjan 
Designation  Assistant Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA 
Address  Department of Psychiatry AIIMS PATNA Phulwari Shariff Patna Bihar-801507

Patna
BIHAR
801507
India 
Phone  9717531800  
Fax    
Email  rajeevranjan0087@gmail.com  
 
Details of Contact Person
Public Query  
Name  Yash Jaiswal 
Designation  Student 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA 
Address  AIIMS PATNA Phulwari Shariff Patna Bihar-801507

Patna
BIHAR
801507
India 
Phone  9871374705  
Fax    
Email  yash.jswl@gmail.com  
 
Source of Monetary or Material Support  
Department of psychiatry AIIMS Patna Phulwari Shariff Patna Bihar-801507 
 
Primary Sponsor  
Name  AIIMS PATNA 
Address  AIIMS PATNA Phulwari Shariff Patna Bihar-801507 
Type of Sponsor  Government medical college 
 
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 Yash Jaiswal  AIIMS PATNA  Surgical oncology ward Phulwari Shariff Patna Bihar-801507
Patna
BIHAR 		 8882121936

yash.jswl@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, All India Institute of Medical Sciences, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Music therapy and Treatment as usual for pain, anxiety, depression and stress symptoms in post-surgical cancer patients till the time of discharge  These are music tracks downloaded from the internet to be played for 20 minutes in each session everyday till the day of discharge for the intervention group via headphones. 
Comparator Agent  Treatment as usual for pain, anxiety, depression and stress symptoms in post-surgical cancer patients  Treatment as usual given to post-surgical cancer patients for pain, anxiety, depression and stress symptoms till the time of discharge. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All cancer patients operated, stable and post-operative clinical care at surgical oncology
ward
Post-surgical cancer patients with age range between 18-65
Willing to give informed consent for the therapeutic intervention and to participate in the
study 
 
ExclusionCriteria 
Details  Any form of significant hearing and other sensory impairment
Significant cognitive impairment
Co-morbid diagnosed psychiatric condition
Neurological disorder or significant medical condition impeding communication
Uncooperative patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the change in pain & anxiety symptom severity (measured by change in VAS pain
score, DASS-21 scores) from baseline after 2 weeks treatment with music therapy plus treatment as
usual (TAU) versus treatment as usual (TAU) in post-surgical cancer patients. 		 Pain and anxiety symptoms severity to be assessed at baseline and at the time of discharge using the VAS pain score and DASS-21 questionnaire respectively 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the change in depression & stress symptom severity (measured by change in DASS-21 scores) from baseline after 2 weeks treatment with music therapy plus treatment as
usual (TAU) versus treatment as usual (TAU) in post-surgical cancer patients. 		 Depression & stress symptom severity to be assessed at baseline & at the time of discharge using the DASS-21 questionnaire. 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   10/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

Cancer, a chronic disease which is one of the leading causes of death. Cancer patients suffer from mental trauma like depression, anxiety, stress and pain during the disease and also after undergoing surgery. A non-invasive, inexpensive, easily accessible non-pharmacological intervention like Music can be quite effective in relieving these post-operative cancer patients of the depression, anxiety, stress and pain symptoms. Therefore, we aim to evaluate the change in pain, stress, depression and anxiety scores from baseline after 2 weeks treatment with music therapy plus treatment as usual (TAU) versus treatment as usual (TAU) in post-surgical cancer patients.

 

The study to be conducted for a period of two months after being approved from Institute’s Ethics Committee. It will be a prospective, randomized, open-label parallel design trial with a sample size of 44 divided into two groups i.e. Group A with sample size of 22 received music therapy along with the standard treatment regimen and a control group B (Treatment as usual) in which patients only received the standard treatment regimen. This study will involve use of tailor- made music tracks which will contain standardized music which have been proven to relieve patients suffering from depression, anxiety, stress and pain symptoms. Depression, Anxiety, Stress symptoms will be assessed using DASS 21 questionnaire and Pain symptoms will be analyzed using Visual Analogue Scale (VAS). The data obtained will be analyzed using the software IBM SPSS 22.0.

 
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