| CTRI Number |
CTRI/2026/01/100607 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to assess the effect of kangaroo care on empathy in MBBS students |
|
Scientific Title of Study
|
To Compare the effectiveness of counseling skills including emphathy between mbbs students who first administer Kangaroo mother care and then counsel parents versus those who only counsel parents |
| Trial Acronym |
KMC-Empathy |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Somashekhar Nimbalkar |
| Designation |
Professor |
| Affiliation |
Bhaikaka University |
| Address |
Department of Neonatology HM Patel Academic Center Pramukhswami Medical College Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9428067811 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Somashekhar Nimbalkar |
| Designation |
Professor |
| Affiliation |
Bhaikaka University |
| Address |
Department of Neonatology HM Patel Academic Center Pramukhswami Medical College Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9428067811 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Somashekhar Nimbalkar |
| Designation |
Professor |
| Affiliation |
Bhaikaka University |
| Address |
Department of Neonatology HM Patel Academic Center Pramukhswami Medical College Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9428067811 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pramukhswami Medical College |
| Address |
Gokalnagar
Karamsad |
| Type of Sponsor |
Private 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 |
| aditya |
pramukhswami Medical College |
Room Number 1,
Postnatal NICU ward
Department of Neonatology
Shree Krishna hospital karamsad
Anand
GUJARAT |
9428067811
adityabhatt47@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy medical students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
administration of kmc |
kmc will be administered by medical students after appropriate consent and asepsis. There will be a minimum of 60 minutes given by the student and one session is minumum. The students in KMC group are free to give more to a maximum of 12 hours across a week. |
| Comparator Agent |
no administration of kmc |
they will be only taught regardin kmc theory |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
Undergraduate MBBS students in their clinical years. |
|
| ExclusionCriteria |
| Details |
students with any prior training or exposure to kmc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of counseling skills, including empathy, between MBBS students who first administer Kangaroo Mother Care (KMC) and then counsel parents, versus those who directly counsel parents. |
To compare the effectiveness of counseling skills, including empathy, between MBBS students who first administer Kangaroo Mother Care (KMC) and then counsel parents, versus those who directly counsel parents.
Once after finishing the first episode of KMC and once after two weeks- four week from the first episode. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of experiential learning (administering KMC) on the empathy levels of MBBS students and evaluate the overall counseling self-efficacy of both groups using the Jefferson Scale of Physician Empathy (JSPE-S) |
immediately |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
02/02/2026 |
| 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="0"
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 - NO
|
|
Brief Summary
|
A randomized controlled trial (RCT) involving undergraduate MBBS students to evaluate the impact of different counselling approaches on empathy and counselling skills. Undergraduate students currently studying in the Pramukhswami Medical college shall be given one week training in kangaroo mother care(theoretical) after 5pm. They will then fill up the pre intervention Jefferson Scale of Physician Empathy (JSPE-S) questionnaire. They will then be allotted in the either group and be called to administer kangaroo mother care after proper consent from the parents of the newborn. Following this they will fill up the Jefferson Scale of Physician Empathy (JSPE-S) post intervention. |