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临床试验/CTRI/2025/07/090137
CTRI/2025/07/090137尚未招募3 期

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 only counsel parents.

Pramukhswami Medical College1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
128
试验地点
1
主要终点
Empathy Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
17.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Medical sudents in MBBS course who have not had any exposure to KMC before.

排除标准

  • Students who deny consent or those who have administered KMC before.

结局指标

主要结局

Empathy Score

时间窗: Immediately After Intervention is completed

次要结局

  • 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)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Somashekhar Nimbalkar

Bhaikaka University

研究点 (1)

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