Midwifery StudentsNCT06283810
The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy
A study testing psychotherapy of interpersonal relationships, laughter therapy and Plasebo in people with Midwifery Students, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Midwifery Students
- What is being tested?
- psychotherapy of interpersonal relationships, laughter therapy and Plasebo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - 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".
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34320
About this study
Official title: The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy on Interpersonal Relationships, Problem Solving and Self-Reflection in Midwifery Students
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)
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.
- Conditions
- Midwifery Students
- Being tested
- psychotherapy of interpersonal relationships, laughter therapy, Plasebo
- Keywords
- self reflection, interpersonel relationship, laughter therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychotherapy of interpersonal relationshipsBehavioural
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.
laughter therapyBehavioural
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.
PlaseboBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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".
Measured: 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.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Midwifery StudentsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Uncu, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283810
- Sponsor's protocol ID
- 2023/168
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy on Interpersonal Relationships, Problem Solving and Self-Reflection in Midwifery Students
- ClinicalTrials.gov ID
- NCT06283810
- Acronym / sponsor ID
- 2023/168
- Conditions
- Midwifery Students
- Keywords
- self reflection, interpersonel relationship, laughter therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| psychotherapy of interpersonal relationships | Experimental | Behavioral: 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. |
| laughter therapy | Experimental | Behavioral: laughter therapyIn 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 |
| Plasebo group | Placebo comparator | Behavioral: Plasebo"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. |
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- - 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".
Key exclusion criteria (7 listed)
- - 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychotherapy of interpersonal relationshipsGroup 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. | Behavioural | psychotherapy of interpersonal relationships |
| laughter therapyLaughter 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. | Behavioural | laughter therapy |
| PlaseboAfter 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. | Behavioural | Plasebo group |
Primary outcome
self-reflection skills
Time frame: 12 week
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).
problem solving skills
Time frame: 12 week
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".
interpersonal relationship skills
Time frame: 12 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Results publication: PubMed 37303065Namazinia 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.
- Individual participant dataSharing planned: No
Related trials for Midwifery Students
Not yet recruiting
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
Episiotomy Repair Training
Not yet recruiting
Effect of Gamified Neonatal Initial Care Education on Midwifery Students
Midwifery Education, Neonatal Care Education
Not yet recruiting
Model-Based Episiotomy Training
Episiotomy
Not yet recruiting
Effects of EbeCast Digital Learning on Midwifery Students' Women's Health Skills
Midwifery Education, Clinical Skills Training
Not yet recruiting
Psychosocial Effects of Empathy-Based Midwifery Education on Midwifery Students and Pregnant Women
Empathy, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychotherapy of interpersonal relationships, laughter therapy and Plasebo in people with Midwifery Students, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reflection skills (time frame: 12 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06283810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.