TherapyNCT07522840
Menopause, Laughter Therapy, and Well-Being
A study testing grup 1 laughter yoga therapy in people with Therapy and Menopause, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
The intervention will be conducted by Assist. Prof. Dr. Nurten ÖZÇALKAP. No invasive procedures will be performed; participants will engage in deep breathing, warm-up exercises, playful activities, and laughter exercises. The researcher holds an internationally certified training in laughter therapy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- What is being tested?
- grup 1 laughter yoga therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 30 Jun 2025
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Willingness to participate in the study
- Ability to communicate
- Having entered menopause within the last 3 years
- Having experienced natural menopause
- Being literate
Who cannot join
- Having undergone surgical menopause
- Having a serious psychiatric or neurological disorder (e.g., schizophrenia, bipolar disorder, dementia, epilepsy)
- Having a chronic disease that may significantly affect overall quality of life and cognitive functions
- Having a physical condition that prevents participation in laughter therapy sessions (e.g., respiratory distress, vertigo, incontinence, severe cardiac disease)
- Using antidepressants or engaging in other non-pharmacological methods to reduce stress
- Receiving hormone replacement therapy
- Having experienced a traumatic event within the past year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ağri İbrahim Çeçen Universty
Ağrı, Ağri, 04100
About this study
Official title: The Effect of Laughter Therapy on Brain Fog, Psychological Well-Being, and Sleep Quality in Women During Menopause
The intervention will be conducted by Assist. Prof. Dr. Nurten ÖZÇALKAP. No invasive procedures will be performed; participants will engage in deep breathing, warm-up exercises, playful activities, and laughter exercises. The researcher holds an internationally certified training in laughter therapy.
Intervention Group
Read more
Participants will be invited face-to-face, informed about the study, and provide consent. They will be assigned to groups of 8 - 9 and receive laughter yoga twice weekly for a total of 8 sessions (20-40 minutes each) in a suitable hospital or institutional setting.
Baseline assessments will include the Introductory Information Form, Brain Fog Scale, Psychological Well-Being Scale, and Sleep Quality Scale. These scales will be re-administered after the 8th session.
Control Group Participants will be recruited similarly and provide consent. Baseline assessments will be conducted using the same instruments. Post-test assessments will be performed 4 weeks later.
After study completion, control group participants who wish will be offered one session of laughter yoga.
Read the detailed description
The intervention will be conducted by Assist. Prof. Dr. Nurten ÖZÇALKAP. No invasive procedures will be performed; participants will engage in deep breathing, warm-up exercises, playful activities, and laughter exercises. The researcher holds an internationally certified training in laughter therapy.
Intervention Group Participants will be invited face-to-face, informed about the study, and provide consent. They will be assigned to groups of 8 - 9 and receive laughter yoga twice weekly for a total of 8 sessions (20-40 minutes each) in a suitable hospital or institutional setting.
Baseline assessments will include the Introductory Information Form, Brain Fog Scale, Psychological Well-Being Scale, and Sleep Quality Scale. These scales will be re-administered after the 8th session.
Control Group Participants will be recruited similarly and provide consent. Baseline assessments will be conducted using the same instruments. Post-test assessments will be performed 4 weeks later.
After study completion, control group participants who wish will be offered one session of laughter yoga.
- Conditions
- Therapy, Menopause, Sleep, Psychological Well-being, Women
- Being tested
- grup 1 laughter yoga therapy
- Keywords
- Menopause, laughter yoga, brain fog, psychological well-being, sleep quality
- Medical subject headings
- Psychological Well-Being, Mental Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
grup 1 laughter yoga therapyOther
Participants received a total of 8 sessions of laughter yoga therapy, conducted twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 laughter yoga therapy | Experimental | Participants received a total of 8 sessions of laughter yoga therapy, conducted twice weekly. Receives: Other: grup 1 laughter yoga therapy |
| Group 2 Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form:
This form was developed by the researchers based on the literature and includes questions on participants' sociodemographic characteristics.
Measured: Baseline
Brain Fog Scale
This scale consists of 30 items and three subdimensions. The total score ranges from 30 to 150. The cognitive symptoms subscale ranges from 17 to 85, the physical symptoms subscale from 8 to 40, and the psychological symptoms subscale from 5 to 25. Higher scores on the total scale and/or subscales indicate greater levels of brain fog.
Measured: Baseline, After 4 weeks
Psychological Well-Being Scale
Developed by Diener et al. and adapted into Turkish by Telef, this scale consists of eight items. The items assess components such as individuals' sense of competence, quality of relationships, and life evaluation. The scale contains no reverse-scored items and uses a 7-point Likert format ranging from 1 (strongly agree) to 7 (strongly disagree). The total score ranges from 8 to 56, with higher scores indicating higher psychological well-being. Six items assess core dimensions of well-being, while two items contribute to score balance. The Cronbach's alpha coefficient of the scale was reported as 0.87.
Measured: Baseline, After 4 weeks
Pittsburgh Sleep Quality Index (PSQI)
The PSQI was developed in 1989, and its validity and reliability in Türkiye were established in 1996. It assesses sleep quality and disturbances over a one-month period. The index includes 24 items; however, item 19 and the last five items are used for clinical information only and are not included in scoring. The remaining 18 self-reported items evaluate seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored between 0 and 3, and the sum of these yields a global PSQI score ranging from 0 to 21. A total score above 5 indicates poor sleep quality, while a score of 5 or below indicates good sleep quality. The Cronbach's alpha coefficient of the scale was reported as 0.80.
Measured: Baseline, After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Dec 2024
- Primary completion1 Mar 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TherapyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURTEN ÖZÇALKAP, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522840
- Sponsor's protocol ID
- 2024/13
- Other IDs
- Laughter Therapy
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical considerations and the need to protect participant confidentiality. The data contain sensitive personal information, and participants did not provide consent for public data sharing. However, anonymized data may be made available upon reasonable request to the corresponding author.
Publications
Telef, B. B. (2013). Psikolojik İyi Oluş Ölçeği: Türkçeye uyarlama, geçerlik ve güvenirlik çalışması. Hacettepe Üniversitesi Eğitim Fakültesi Dergisi, 28(3), 374-384.
Atik D, Inel Manav A. A Scale Development Study: Brain Fog Scale. Psychiatr Danub. 2023 Spring;35(1):73-79. doi: 10.24869/psyd.2023.73.
PubMed 37060595
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Therapy on Brain Fog, Psychological Well-Being, and Sleep Quality in Women During Menopause
- ClinicalTrials.gov ID
- NCT07522840
- Acronym / sponsor ID
- 2024/13
- Conditions
- Therapy, Menopause, Sleep, Psychological Well-being, Women
- Keywords
- Menopause, laughter yoga, brain fog, psychological well-being, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Apr 2026 (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.
The intervention will be conducted by Assist. Prof. Dr. Nurten ÖZÇALKAP. No invasive procedures will be performed; participants will engage in deep breathing, warm-up exercises, playful activities, and laughter exercises. The researcher holds an internationally certified training in laughter therapy.
Intervention Group
Participants will be invited face-to-face, informed about the study, and provide consent. They will be assigned to groups of 8 - 9 and receive laughter yoga twice weekly for a total of 8 sessions (20-40 minutes each) in a suitable hospital or institutional setting.
Baseline assessments will include the Introductory Information Form, Brain Fog Scale, Psychological Well-Being Scale, and Sleep Quality Scale. These scales will be re-administered after the 8th session.
Control Group Participants will be recruited similarly and provide consent. Baseline assessments will be conducted using the same instruments. Post-test assessments will be performed 4 weeks later.
After study completion, control group participants who wish will be offered one session of laughter yoga.
Detailed description
The intervention will be conducted by Assist. Prof. Dr. Nurten ÖZÇALKAP. No invasive procedures will be performed; participants will engage in deep breathing, warm-up exercises, playful activities, and laughter exercises. The researcher holds an internationally certified training in laughter therapy.
Intervention Group Participants will be invited face-to-face, informed about the study, and provide consent. They will be assigned to groups of 8 - 9 and receive laughter yoga twice weekly for a total of 8 sessions (20-40 minutes each) in a suitable hospital or institutional setting.
Baseline assessments will include the Introductory Information Form, Brain Fog Scale, Psychological Well-Being Scale, and Sleep Quality Scale. These scales will be re-administered after the 8th session.
Control Group Participants will be recruited similarly and provide consent. Baseline assessments will be conducted using the same instruments. Post-test assessments will be performed 4 weeks later.
After study completion, control group participants who wish will be offered one session of laughter yoga.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 laughter yoga therapy | Experimental | Other: grup 1 laughter yoga therapyParticipants received a total of 8 sessions of laughter yoga therapy, conducted twice weekly. |
| Group 2 Control | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Willingness to participate in the study
- Ability to communicate
- Having entered menopause within the last 3 years
- Having experienced natural menopause
- Being literate
Key exclusion criteria (7 listed)
- Having undergone surgical menopause
- Having a serious psychiatric or neurological disorder (e.g., schizophrenia, bipolar disorder, dementia, epilepsy)
- Having a chronic disease that may significantly affect overall quality of life and cognitive functions
- Having a physical condition that prevents participation in laughter therapy sessions (e.g., respiratory distress, vertigo, incontinence, severe cardiac disease)
- Using antidepressants or engaging in other non-pharmacological methods to reduce stress
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 |
|---|---|---|
| grup 1 laughter yoga therapyParticipants received a total of 8 sessions of laughter yoga therapy, conducted twice weekly. | Other | Group 1 laughter yoga therapy |
Primary outcome
Introductory Information Form:
Time frame: Baseline
This form was developed by the researchers based on the literature and includes questions on participants' sociodemographic characteristics.
Brain Fog Scale
Time frame: Baseline, After 4 weeks
This scale consists of 30 items and three subdimensions. The total score ranges from 30 to 150. The cognitive symptoms subscale ranges from 17 to 85, the physical symptoms subscale from 8 to 40, and the psychological symptoms subscale from 5 to 25. Higher scores on the total scale and/or subscales indicate greater levels of brain fog.
Psychological Well-Being Scale
Time frame: Baseline, After 4 weeks
Developed by Diener et al. and adapted into Turkish by Telef, this scale consists of eight items. The items assess components such as individuals' sense of competence, quality of relationships, and life evaluation. The scale contains no reverse-scored items and uses a 7-point Likert format ranging from 1 (strongly agree) to 7 (strongly disagree). The total score ranges from 8 to 56, with higher scores indicating higher psychological well-being. Six items assess core dimensions of well-being, while two items contribute to score balance. The Cronbach's alpha coefficient of the scale was reported as 0.87.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, After 4 weeks
The PSQI was developed in 1989, and its validity and reliability in Türkiye were established in 1996. It assesses sleep quality and disturbances over a one-month period. The index includes 24 items; however, item 19 and the last five items are used for clinical information only and are not included in scoring. The remaining 18 self-reported items evaluate seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored between 0 and 3, and the sum of these yields a global PSQI score ranging from 0 to 21. A total score above 5 indicates poor sleep quality, while a score of 5 or below indicates good sleep quality. The Cronbach's alpha coefficient of the scale was reported as 0.80.
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 22 Apr 2026.
- Results publicationTelef, B. B. (2013). Psikolojik İyi Oluş Ölçeği: Türkçeye uyarlama, geçerlik ve güvenirlik çalışması. Hacettepe Üniversitesi Eğitim Fakültesi Dergisi, 28(3), 374-384.
- Results publication: PubMed 37060595Atik D, Inel Manav A. A Scale Development Study: Brain Fog Scale. Psychiatr Danub. 2023 Spring;35(1):73-79. doi: 10.24869/psyd.2023.73.
- Atik, D., Manav, A.İ. (2023). A Scale Development Study: Brain Fog Scale. Psychiatria Danubina, 35 (1), 73-79.Link provided by the sponsor.
- Telef, B. B. (2013). Psikolojik İyi Oluş Ölçeği: Türkçeye uyarlama, geçerlik ve güvenirlik çalışması. Hacettepe Üniversitesi Eğitim Fakültesi Dergisi, 28(3), 374-384.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical considerations and the need to protect participant confidentiality. The data contain sensitive personal information, and participants did not provide consent for public data sharing. However, anonymized data may be made available upon reasonable request to the corresponding author.
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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 grup 1 laughter yoga therapy in people with Therapy and Menopause, run by Agri Ibrahim Cecen University 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 5 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 22 Apr 2026. 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. 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?
Introductory Information Form: (time frame: Baseline). The study lists 4 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 NCT07522840, which also lists 2 linked publications.
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 22 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.