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CTRI Number  CTRI/2024/07/070231 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Does music and metronome help people learn cardio pulmonary resuscitation. 
Scientific Title of Study   Comparison between music, metronome and metronome superimposed on music in teaching effective cardiopulmonary resuscitation: a prospective interventional 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  Mohammad Khalid 
Designation  Senior Resident 
Affiliation  KMC Manipal, Manipal Academy of Higher Education 
Address  Department of Emergency Medicine, Kasturba Medical College, Manipal Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  8826528407  
Fax    
Email  khalid.mohammad@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Mohammad Khalid 
Designation  Senior Resident 
Affiliation  KMC Manipal, Manipal Academy of Higher Education 
Address  Department of Emergency Medicine, Kasturba Medical College, Manipal Karnataka 576104


KARNATAKA
576104
India 
Phone  8826528407  
Fax    
Email  khalid.mohammad@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Mohammad Khalid 
Designation  Senior Resident 
Affiliation  KMC Manipal, Manipal Academy of Higher Education 
Address  Department of Emergency Medicine, Kasturba Medical College, Manipal Karnataka 576104


KARNATAKA
576104
India 
Phone  8826528407  
Fax    
Email  khalid.mohammad@manipal.edu  
 
Source of Monetary or Material Support  
Department Of Emergency Medicine, Ground floor Kasturba Medical College and Hospital, Manipal Madhavnagar, Manipal Karnataka 576104 
 
Primary Sponsor  
Name  Mohammad Khalid 
Address  Department of Emergency Medicine, Kasturba Medical College, Manipal, Karnataka 576104 
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 
Nitish Reddy Lingala  Kasturba Medical College, Manipal  Sharada interact classroom, Opposite Casualty ICU, Department of Emergency Medicine - Ground floor, Trauma Block Kasturba Medical College, Manipal Madhav Nagar, Manipal Karnataka 576104
Udupi
KARNATAKA 
9380619094

nitish.lingala@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Instituitional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Non healthcare provider (Lay person) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Metronome group   CPR training will be done in Metronome group with metronome playing in the background with a precise tempo of 110 beats per minutes. This auditory prompt will help them to perform CPR in the correct rate. The total duration for training will be three hours. 
Intervention  Metronome superimposed on music group  CPR training will be done in Metronome superimposed on music group with metronome superimposed on the standard song. This auditory prompt will help them to perform CPR in the correct rate. The total duration for training will be three hours. 
Comparator Agent  Music group  CPR training will be done in Music group with music using a standard song – staying alive (By Bee Jees) with beats of 104 per minute or Zinda (By Shankar Ehsaan Loy) with beats of 109 per minute playing in the background. This auditory prompt will help them to perform CPR in the correct rate. The total duration for training will be three hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Lay persons between 18 to 60 year age group 
 
ExclusionCriteria 
Details  Healthcare professionals
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
chest compression rate   30 minutes post CPR training 
 
Secondary Outcome  
Outcome  TimePoints 
chest compression rates  6 weeks post CPR training 
 
Target Sample Size   Total Sample Size="195"
Sample Size from India="195" 
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/ Phase 3 
Date of First Enrollment (India)   15/07/2024 
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="2"
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 - NO
Brief Summary  
Primary objective: To compare difference in appropriate chest compression rate amongst the lay persons trained with music, metronome and metronome superimposed on music immediately post training.

Secondary objective: To compare difference in appropriate chest compression rate amongst the lay persons trained with music, metronome and metronome superimposed on music at 6 weeks post training.

Methodology: Participants fulfilling the inclusion criteria ( lay persons between 18-60 years age group ) and exclusion criteria (healthcare professionals, significant primary or secondary hearing impairment-as reported by subject, prior formal CPR training < 5 years ) will be recruited after informed consent. The centre for Cardiac Arrest and Education (CARE) routinely conducts 1-2 hands only CPR training per month in the community for lay persons (non healthcare providers). During these programmes participants will be enrolled. All participants will be trained for a two-hour session by AHA certified BLS instructors using a combination of didactic instructions and hands on CPR practice using mannequins.
A pretest with questions related to knowledge of CPR will be given using google form.
The participants will be randomly assigned to 3 groups by computer generated randomization.
Group 1 (Metronome group): this group will have a metronome playing in the background with a precise tempo of 110 beats per minute.
Group 2 (Music group): this group will have a standard song – staying alive (By Bee Jees) with beats of 104 per minute or Zinda (By Shankar Ehsaan Loy) with beats of 109 per minute. Among these two, song will be chosen as per familiarity of the majority of the population.
Group 3 (Metronome superimposed on music group): this group will have the metronome superimposed on the music during the training.
All participants will then practice in their respective groups for 1 minute CPR cycles atleast three times.
For each of the groups a CPR instructor will verbally review the correct rate and depth of compressions and intervene/provide feedback if required to maintain the quality of CPR.
Assessment of all participants will be done at the end of training session for 1 minute using QCPR app on mannequin without any auditory prompts. During the final 1-minute analysis no feedback will be provided to participants. QCPR app will assess average rate, depth, chest recoil and provide a CPR score which is a composite of all the above.
Subjective experiences of the participants will be assessed using a standard questionnaire with Likert scale.
A posttest with questions related to knowledge of CPR will be given using google form. In the music group an additional question regarding familiarity with the song will be asked.
Certificates will be provided to all the participants on completion of training.
 
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