1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [somu_somu@yahoo.com].
   


6. For how long will this data be available start date provided 01-08-2025 and end date provided 01-01-2026?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

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.

Participants: Sample Size: Calculate based on power analysis to detect significant differences, Effect Size: 0.5 (medium effect size), Significance Level (alpha): 0.05, Power: 0.8, Allocation Ratio: 1 (equal number of participants in each group)

The power analysis determined that a sample size of approximately 64 participants per group must detect a medium effect size with 80% power at a 5% significance level. Therefore, you would need about 128 participants for the study, with 64 in each group.

Inclusion Criteria: Undergraduate MBBS students in their clinical years.

Exclusion Criteria: Students with prior formal training in counselling.

Randomization:

Randomly assign participants into two groups by randomly generated computer blocks:

Control Group: Directly counsel parents about Kangaroo Mother Care (KMC).

Intervention Group: Administer KMC first and then counsel parents.

Intervention:

Training Session: All participants receive standardized training on KMC and basic counselling techniques.

Implementation: Control Group: Engage in direct JSPE questionnaire.

Intervention Group: Practice KMC with infants for atleast 6 hours, followed by JSPE questionnaire.

Assessment Tools:

 Empathy Measurement: Use the Jefferson Scale of Physician Empathy (JSPE) for self-assessments

Data Collection:

Pre-intervention assessments using JSPE.

Post-intervention assessments using JSPE.

Collect feedback from standardized patients and third-party observers during OSCEs.(if needed)

Ethical Considerations:

Obtain informed consent from all participants.

Ensure confidentiality of participant data.

Seek approval from the institutional ethics committee

Plan of statistical analysis [Details of tables, tests, and other statistical analysis]:

Use statistical software to analyse differences between groups.

Compare pre- and post-intervention scores using paired t-tests or ANOVA for continuous variables.

Analyse categorical data using chi-square tests.

Consider regression analysis to control for potential confounders.