| 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
|
|
|
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
|
|
|
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. |