| CTRI Number |
CTRI/2024/03/063898 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to test whether music and noise cancellation headphones during pacemaker implantation procedure reduces perception of pain and anxiety. |
|
Scientific Title of Study
|
Does perioperative Music and noise cancellation headphones reduce perception of Pain and Anxiety in patients undergoing paCEmaker implantation: Randomised control trial (M-PACE trial) |
| Trial Acronym |
M-PACE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anand Manickavasagam |
| Designation |
Assosciate Professor |
| Affiliation |
Christian Medical College |
| Address |
Cardiology Unit IV,
Department of Cardiology, Christian Medical college,
Ranipet Campus
Vellore
TAMIL NADU
632517
India |
| Phone |
04172224715 |
| Fax |
|
| Email |
dranandchn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anand Manickavasagam |
| Designation |
Assosciate Professor |
| Affiliation |
Christian Medical College |
| Address |
Cardiology Unit IV,
Department of Cardiology, Christian Medical college,
Ranipet Campus
TAMIL NADU
632517
India |
| Phone |
04172224715 |
| Fax |
|
| Email |
dranandchn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anand Manickavasagam |
| Designation |
Assosciate Professor |
| Affiliation |
Christian Medical College |
| Address |
Cardiology Unit IV,
Department of Cardiology, Christian Medical college,
Ranipet Campus
TAMIL NADU
632517
India |
| Phone |
04172224715 |
| Fax |
|
| Email |
dranandchn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College Vellore Tamilnadu India |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College, IDA Scudder Rd, Vellore, Tamil Nadu 632004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anand M |
Christian Medical College |
Cardiology Unit IV, 6th Floor A Block
Christian Medical College,
Ranipet campus, Vellore
Vellore
TAMIL NADU |
8138032331
dranandchn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College, Vellore, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I442||Atrioventricular block, complete, (2) ICD-10 Condition: I441||Atrioventricular block, second degree, (3) ICD-10 Condition: I453||Trifascicular block, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active noise cancellation headphone with no music |
Patients undergoing pacemaker implantation under local anaesthesia will be administered only noise cancellation headphone with no music during the implantation procedure.
Intervention - noise cancellation headphone without music will be administered only once during procedure (Pacemaker Implantation) and it will be continued for entire duration of procedure (2hours). |
| Intervention |
Music therapy via noise cancellation headphones |
Patients undergoing pacemaker implantation under local anaesthesia will be administered music through a noise cancellation headphone during the implantation procedure.
Music will be administered only once during procedure (Pacemaker Implantation) and it will be continued for entire duration of procedure (2 hours). |
| Comparator Agent |
No music and no headphone |
Patients undergoing pacemaker implantation under local anaesthesia and they will not be administered no music and no headphone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing dual chamber pacemaker implantation under local anaesthesia |
|
| ExclusionCriteria |
| Details |
Hearing impairment, High baseline anxiety score and patient with known Psychiatric disorders like generalized anxiety disorders, depression, and bipolar disorders |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative STAI-6 anxiety score between the study groups |
Baseline (preprocedure and 3 hours postprocedure) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the postoperative pain score as measured by VAS between the study groups.
2. To compare the change in STAI-6 anxiety score (postprocedure and preprocedure) between the study groups.
3. To compare the change in pain score (postprocedure and preprocedure) as measured by VAS between the study groups |
Baseline (preprocedure and 3 hours postprocedure) |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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 Applicable |
| 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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dranandchn@gmail.com].
- For how long will this data be available start date provided 05-05-2024 and end date provided 05-12-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients undergoing permanent pacemaker implantation are often anxious. Anxiety may lead to poor cooperation during the procedure, increased pain perception and increased blood pressure.1 Sedatives, anti-anxiety drugs and analgesics are administered in the perioperative period to reduce anxiety and pain. These medications have adverse side effects which can cause morbidity.
Nonpharmacological intervention such as administration of music has been found to have reduction in perioperative anxiety and perception of pain.2 Music therapy has no side effects and is inexpensive. It has been used as an adjunct to analgesics or antianxiety medications to reduce anxiety and pain. The data on music administration during pacemaker implantation under local anesthesia is sparse. There are only few studies which compared music therapy versus noise cancellation headphones on pain perception and anxiety in the perioperative period and these studies have shown contradictory results.3 Since the effect of noise cancellation headphones on anxiety and pain perception is not clearly known, it was decided to have three arms comparing 1) music vs 2)Noise cancellation headphones with no music vs 3) No music and no headphone.
This study is aimed at comparing the effects of music therapy via noise cancellation headphone (Group A) on anxiety and perception of pain in patients undergoing pacemakermplantation under local anaesthesia verses active noise cancellation headphones with no music (Group B) and no music and no headphone (Group C).
1. Kain ZN, Sevarino F, Alexander GM, et al. Preoperative anxiety and postoperative pain in women undergoing hysterectomy. A repeated-measures design. J Psychosom Res 2000;49:417–22 2. Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev 2013;(6):Cd006908. 3. Ligree N, Nanda S, Morwal S, Garg K. Effect of binaural beat music and noise cancelling headphones on intraoperative anxiety in patients undergoing spinal anaesthesia – A randomised controlled study. Indian J Anaesth 2023;67:590-4. |