| CTRI Number |
CTRI/2024/06/068280 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Active counselling and music therapy ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Listening music and talking to breast cancer surgery patients decreases pain |
|
Scientific Title of Study
|
Effect of active counselling with music therapy on total pain score in patient undergoing for breast cancer surgery under general anaesthesia -A randomised 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 |
Rana kausar |
| Designation |
post graduate student |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Depart of anaesthesia , neuro ot complex ,1st floor ward block ,Igims , sheikhpura ,patna
Patna
BIHAR
800014
India |
| Phone |
8002139208 |
| Fax |
|
| Email |
ranukausar@145gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Arun |
| Designation |
Additional Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
| Address |
Depart of anaesthesia , neuro ot complex ,1st floor ward block ,Igims ,sheikhpura ,patna
Patna
BIHAR
800014
India |
| Phone |
9523594059 |
| Fax |
|
| Email |
janya.mukesh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Arun |
| Designation |
Additional Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna |
| Address |
Depart of anaesthesia , neuro ot complex ,1st floor ward block ,Igims ,sheikhpura ,patna
Patna
BIHAR
800014
India |
| Phone |
9523594059 |
| Fax |
|
| Email |
janya.mukesh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dept of anaesthesia, neuro ot complex, 1st floor ward block, Igims sheikhpura, patna, 800014 |
|
|
Primary Sponsor
|
| Name |
Dr Rana kausar |
| Address |
Dept of anaesthesia , neuro ot complex, 1st floor ward block, Igims, Sheikhpura,
patna, 800014 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rana Kausar |
Indira Gandhi Institute of Medical Sciences, Patna |
Dept of anaesthesia, neuro ot complex, 1st floor ward block Igims, sheikhpura, patna, 800014
Patna
BIHAR |
8002139208
ranukausar145@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Indira Gandhi Institute of Medical Sciences ,patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: O||Medical and Surgical, (5) ICD-10 Condition: O||Medical and Surgical, (6) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
music therapy group |
Music therapy and active counselling given to breast cancer patients and check the total pain score and numerical rating scale score in post-operative area just after surgery, 1 hour, 2 hour 8 hour, 12 hour And 24 hour |
| Comparator Agent |
Non music therapy group |
Calculate total pain score and numerical rating scale score and total opiod consumption in breast cancer patients without giving music therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1-greater than 18yr
2-ability to speak and respond of questions
3-free of any hearing impairment
4-posted for elective surgery for breast cancer under general anaesthesia
5-oriented to time ,place and person
6-no known mental disability
7-otherwise healthy or having comorbidities i.e. adequately treated comorbidities |
|
| ExclusionCriteria |
| Details |
1-patients refusal
2-previous history of chronic pain other than related to disease
3-any major intra-op event like massive haemorrhage, cardiovascular arrest, surgery abandoned and post-op event like re-exploration, post-op bleeding, sepsis and any thromboembolic event will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the change in total pain scores just before surgery in pre operative waiting area |
Preoperative period (24hours before surgery) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the decrease in total analgesia consumption in terms of morphine equivalent in first 24hours |
Post operative period for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="1"
Months="6"
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
|
We will observe the total pain score in the patients undergoing for breast cancer surgery under general anaesthesia by selecting two groups i.e music therapy group, In music therapy group when patient will arrive in pre-operative area day 1 before surgery counsellor will do active counselling and give 30minute music therapy of patient’s choice and anaesthetist will record baseline total pain score and numerical rating scale score and we will do the same things on day of surgery and one day after surgery and in non music therapy group we will only record the numerical rating scale score and total pain score on same days , by doing this we will observe total pain score in ot before induction and numerical rating scale in post operative period just after surgery and total opioid consumption.
|