| CTRI Number |
CTRI/2025/08/092374 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of music therapy on stress response to breathing tube insertion in patients undergoing general elective surgery. |
|
Scientific Title of Study
|
Effect of music therapy on hemodynamic response to endotracheal intubation in patients undergoing elective surgery under general anaesthesia: A randomized controlled 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 |
Dr Mukul Kumar |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, Room no. 308, 3rd floor BL Taneja Block, Maulana Azad Medical College, 2, Bahadurshah Zafar Marg, New Delhi-110002
2, Bahadurshah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
8375971999 |
| Fax |
|
| Email |
mk7050632@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Wadhawan |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, Room no. 308, 3rd floor BL Taneja Block, Maulana Azad Medical College, 2, Bahadurshah Zafar Marg, New Delhi-110002
2, Bahadurshah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9810946845 |
| Fax |
|
| Email |
soniawadhawan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia Wadhawan |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology, Room no. 308, 3rd floor BL Taneja Block, Maulana Azad Medical College, 2, Bahadurshah Zafar Marg, New Delhi-110002
2, Bahadurshah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9810946845 |
| Fax |
|
| Email |
soniawadhawan@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur shah zafar marg, New Delhi-110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Department of Anaesthesiology, Room no. 308, 3rd floor BL Taneja Block, Maulana Azad Medical College, Bahadurshah Zafar Marg, New Delhi-110002, India |
| Type of Sponsor |
Government medical college |
|
|
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 Mukul Kumar |
Lok Nayak Hospital |
OT Block OT-1,2,3 new operation theatre block, Department of Anaesthesiology, New Delhi-110002
Central
DELHI |
8375971999
mk7050632@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music Therapy |
This group will receive music therapy (Raga Hamsadhwani) which will be started preoperatively continued intraoperatively and will be discontinued post extubation. |
| Comparator Agent |
Noise cancellation Headphoens |
In this group only ambient noise cancelling headphones without music would be applied to the patients preoperatively and will be removed post extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 American Society of Anesthesiologists Physical Status ASA I and II
2 Expected duration of elective surgery less than 2 hours
|
|
| ExclusionCriteria |
| Details |
1 Patient with hearing impairment
2 Diagnosed psychiatric or neurological illness
3 Hypertensive patients on beta blocker
4 Known case of heart disease
5 Mallampati class III and IV
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in heart rate to intubation in patients undergoing elective surgery under general anaesthesia |
2, 4, 6, 8, 10 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change in mean arterial pressure to intubation as a effect of music therapy
2. Mean preoperative anxiety as assessed by Amsterdam preoperative anxiety & information scale (APAIS)
3. Mean HR, MAP, SBP, DBP
4. Mean intra operative inhalational anaesthetic agent isoflurane consumption
5. Mean time taken from cessation of inhalational anaesthetic agent to extubation
6. Mean serum cortisol levels |
1. 2, 4, 6, 8, 10 minutes post intubation then every 5 minutes
2. Baseline, 10 minutes after music therapy
3. 2, 4, 6, 8, 10 minutes post intubation then every 5 minutes
4. At the end of surgery after extubation
5. Closure of isoflurane to extubation
6. Baseline, 2minutes, 4 hours |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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 2 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mk7050632@gmail.com].
- For how long will this data be available start date provided 15-06-2027 and end date provided 14-06-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In this research there will be 2 groups, one in which we will apply headphones and play Raga Hamsadhwan, which is an instrumental flute, will be group M, and another group, C, in which we will apply only ambient noise-cancelling headphones. Baseline anxiety A0 and hemodynamic parameters, heart rate, blood pressure, and oxygen saturation T0 will be measured. After 10 minutes of music therapy, we will again assess the anxiety level A1 and hemodynamic parameters, heart rate, blood pressure and oxygen saturation T1 We will shift the patient to the operating theatre with headphones on and induce the patient with standard general anaesthesia using propofol, fentanyl and vecuronium. We will intubate the patient with direct laryngoscopy and measure the hemodynamic parameters immediately and at 2-minute intervals for 10 minutes for stress response to intubation and every 5 minutes thereafter. Maintain the depth of anaesthesia with isofluran,e oxyge, nitrous oxide, and an intraoperative bolus of fentanyl and vecuronium, and maintain a BIS of 40-60 Then we will extubate the patient post-surgery after achieving a TOF ratio of 0.9 and adequate signs of neuromuscular monitoring We will stop the music which was playing intraoperatively only after extubation We will also take blood samples for S. cortisol at baseline pre-operative, 2 min post-intubation and 4 hours post-intubation to compare levels of stress response along with anxiety and hemodynamic parameters |