NCT06283810

Brief Summary

Midwives, who have an important place in the health system, are expected to be equipped to meet the health care needs of women (Fışkın \& Doğan, 2020). Therefore, midwifery students, who are known to play a role in promoting women's health, should have good interpersonal relationships, good problem-solving skills, and high self-reflection and insight, which are assumed to be effective in both, in order to fulfill these responsibilities. Translated with DeepL.com (free version)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 28, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

February 13, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

self reflectioninterpersonel relationshiplaughter therapy

Outcome Measures

Primary Outcomes (3)

  • self-reflection skills

    It is thought that self-reflection plays a mediating role in the interpersonal relationships and problem solving skills of the students in the study. For this reason, it was decided to determine the self-reflection characteristics of the students, but a suitable scale could not be found. Thus, it was decided to develop a scale to determine the self-reflection characteristics of students studying in Health Sciences. In this direction, the scale development study was carried out by obtaining the approval of Istanbul University-Cerrahpaşa Social and Human Sciences Research Ethics Committee (2023/120) and the necessary permission from Istanbul University-Cerrahpaşa Faculty of Health Sciences Dean's Office (06.10.2023-802307).

    12 week

  • problem solving skills

    Problem Solving Inventory was developed by Heppner and Peterson (1982). It was adapted into Turkish by Taylan (1990), Şahin, Şahin and Heppner (1993). The scale is a six-point Likert-type scale consisting of 35 items and three factors. The first of the three factors is problem solving confidence (11 items), the second is problem avoidance/approach (16 items), and the third is control (15 items). Scale options are scored between one and six as "I always behave like this" and "I never behave like this".

    12 week

  • interpersonal relationship skills

    Interpersonal Relationship Dimension Scale (IRDS; ANNEX-3): This scale was developed by İmamoğlu and Aydın (2009). The IBS is a 5-point Likert-type scale consisting of 53 items, which is suitable for Turkish conditions, analyses interpersonal relationships and determines relationship dimensions. The scale consists of four sub-dimensions: Consent Dependence, Empathy, Trust in Others and Emotion Awareness.

    12 week

Study Arms (4)

psychotherapy of interpersonal relationships

EXPERIMENTAL

"Informed Consent Form" and "Voluntary Consent Form" will be presented to the students assigned to Group 1 in the first interview and their consent will be obtained, "Student Information Form (ANNEX-1)", "CIBS (ANNEX-3)", PCI (ANNEX-4), CPI (ANNEX-5) and SB3S (ANNEX-6) will be applied. After the initial data are collected, 2-3 sessions of individual interviews will be conducted to assess the student's suitability for Group CIPT.

Behavioral: psychotherapy of interpersonal relationships

laughter therapy

EXPERIMENTAL

In the first interview, "Informed Consent Form" and "Voluntary Consent Form" will be presented to the students assigned to Group 2 and their consent will be obtained, and "Student Information Form (ANNEX-1)", "CIBS (ANNEX-3)", PCI (ANNEX-4), CPI (ANNEX-5) and SB3S (ANNEX-6) will be applied. After the initial data were collected, the students in Experiment 2 will be informed about Laughter Therapy and Group IPT. An agreement will be made with the students about the points to be considered regarding laughter therapy

Behavioral: laughter therapy

Plasebo group

PLACEBO COMPARATOR

"Informed Consent Form" and "Voluntary Consent Form" were presented to the students in the placebo group in the first interview and their consent was obtained, "Student Information Form (ANNEX-1)", "CIBS (ANNEX-3)", PCI (ANNEX-4), CPI (ANNEX-5) and SB3S (ANNEX-6) were applied.

Behavioral: Plasebo

control group

NO INTERVENTION

The students assigned to G4 will be informed that they are in the control group and that no application will be made. After the completion of the study data (by giving information about Group CIPT and laughter therapy), it will be stated that they can receive Group CIPT or laughter therapy if they wish.

Interventions

Group KIPT will be 1 session per week and each session will last 90 minutes. There will be 7 sessions in total, and a completion session will be held 2 weeks after the completion of Group KIPT. In order for the students in G1 to understand which group they are in, they will also be informed about the points to be considered regarding laughter therapy. An unstructured laughter intervention will be applied at the beginning or at the end of the sessions in which group IPT is applied. Measurements will be made using "ANNEX-3, ANNEX-4, ANNEX-5, ANNEX-6" in the 4th week (intervention interval), 8th week (end of intervention) and 12th week (long-term effect). Within the scope of work packages 3 and 4, KIPT application and other measurements will be made.

psychotherapy of interpersonal relationships

Laughter therapy is 1 session per week and each session will last 40 minutes. A total of 8 sessions will continue. Each session will start with warm-up and deep breathing exercises and will continue with applause and childish games. Afterwards, games specific to each session will be added. Unstructured interviews will be conducted with G2 at the beginning or at the end of the session, suggesting that they were subjected to group CIPT. Measurements will be made using "ANNEX-3, ANNEX-4, ANNEX-5, ANNEX-6" in the 4th week (intervention interval), 8th week (end of intervention) and 12th week (long-term effect) when the interviews start.

laughter therapy
PlaseboBEHAVIORAL

After the initial data are collected, unstructured interviews about the interpersonal relationships of the person will be conducted by conducting individual interviews with each student for 2-3 sessions at the beginning of the study in case the student does not understand which group he/she is in. Afterwards, unstructured random interviews and laughter intervention will be conducted for a total of 8 sessions lasting 40 minutes, 1 session per week. Measurements will be made using "ANNEX-3, ANNEX-4, ANNEX-5, ANNEX-6" in the 4th week, 8th week and 12th week (long-term effect) when the interviews start.

Plasebo group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- To be a 1st, 2nd and 3rd year student of Istanbul University-Cerrahpaşa Faculty of Health Sciences, Department of Midwifery.
  • To get less than 2 points from the "General Health Questionnaire".

You may not qualify if:

  • \- Those with an indifferent attachment style,
  • Those with antisocial or narcissistic traits,
  • Those with active suicidal thoughts,
  • People with psychiatric diagnosis and medication,
  • Those with urinary incontinence,
  • Those with severe back pain,
  • Those who have undergone surgical operation within the last 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34320, Turkey (Türkiye)

Location

Related Publications (1)

  • Namazinia M, Mazlum SR, Mohajer S, Lopez V. Effects of laughter yoga on health-related quality of life in cancer patients undergoing chemotherapy: a randomized clinical trial. BMC Complement Med Ther. 2023 Jun 12;23(1):192. doi: 10.1186/s12906-023-04028-2.

MeSH Terms

Interventions

Laughter Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 28, 2024

Study Start

March 1, 2024

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

October 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations