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CompletedNCT06283810Updated Oct 28, 2024

The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy

An interventional study of psychotherapy of interpersonal relationships and laughter therapy in Midwifery Students, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
Female
01

Study 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.

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Read the detailed description

Self-reflection supports the development of strategies for self-monitoring and professional competence by improving problem-solving skills. Self-reflection serves as an important building block in the integration and structuring of experience and sense of self, as well as providing continuity, coherence and meaning to life. It is thought that midwives with self-reflection will be more logical, healthy, happy and successful. It is seen that midwives with high self-reflection are dedicated to lifelong learning, examining, reflecting and developing, and develop personally and professionally (Bass et al., 2022). The quality of care will increase as midwives who develop self-reflection can observe, investigate, evaluate and discover events with a realistic eye while providing care, thus the midwifery profession will progress as a scientific discipline.

02

Conditions studied

  • Midwifery Students

Keywords

  • self reflection
  • interpersonel relationship
  • laughter therapy
03

In context

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

    • 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".

Exclusion criteria

Exclusion Criteria:

    • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    psychotherapy of interpersonal relationships

    "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

  • Experimental
    laughter therapy

    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

  • Placebo comparator
    Plasebo group

    "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

  • No intervention
    control group

    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

  • Behavioralpsychotherapy of interpersonal relationships

    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.

  • Behaviorallaughter therapy

    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.

  • BehavioralPlasebo

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 week

  2. 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".

    Time frame: 12 week

  3. 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.

    Time frame: 12 week

07

Study locations

1 site
  • Istanbul University-Cerrahpasa
    Istanbul, 34320, Turkey
08

References and documents

Publications

  • 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. PubMed 37303065 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06283810
Lead sponsor
Istanbul University - Cerrahpasa
Responsible party
Betul Uncu (Principal Investigator, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Feb 28, 2024
Start date
Mar 1, 2024
Primary completion
Jun 30, 2024
Completion
Jul 30, 2024
Last update
Oct 28, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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