Menopause, Laughter Therapy, and Well-Being

NCT07522840 | Completed

• 2 other identifiers: 2024/13Laughter Therapy
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Menopause; laughter yoga; brain fog; psychological well-being; sleep quality

Outcome Measures

Primary Outcomes (4)

• Introductory Information Form:

  This form was developed by the researchers based on the literature and includes questions on participants' sociodemographic characteristics.

  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.

  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.

  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.

  Baseline, After 4 weeks

Study Arms (2)

Group 1 laughter yoga therapy

EXPERIMENTAL

Participants received a total of 8 sessions of laughter yoga therapy, conducted twice weekly.

Other: grup 1 laughter yoga therapy

Group 2 Control

NO INTERVENTION

Interventions

grup 1 laughter yoga therapy OTHER

Participants received a total of 8 sessions of laughter yoga therapy, conducted twice weekly.

Group 1 laughter yoga therapy

Eligibility Criteria

• Gender Eligibility Details: Menopausal Women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate in the study
• Ability to communicate
• Having entered menopause within the last 3 years
• Having experienced natural menopause
• Being literate

You may not qualify if:

• 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

Sponsors & Collaborators

• Agri Ibrahim Cecen University: lead

Study Sites (1)

Ağri İbrahim Çeçen Universty

Ağrı, Ağri, 04100, Turkey (Türkiye)

Location

Related Publications (2)

• Telef, B. B. (2013). Psikolojik İyi Oluş Ölçeği: Türkçeye uyarlama, geçerlik ve güvenirlik çalışması. Hacettepe Üniversitesi Eğitim Fakültesi Dergisi, 28(3), 374-384.

  RESULT

• 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.

  PMID: 37060595 RESULT

Related Links

• Atik, D., Manav, A.İ. (2023). A Scale Development Study: Brain Fog Scale. Psychiatria Danubina, 35 (1), 73-79.
• Telef, B. B. (2013). Psikolojik İyi Oluş Ölçeği: Türkçeye uyarlama, geçerlik ve güvenirlik çalışması. Hacettepe Üniversitesi Eğitim Fakültesi Dergisi, 28(3), 374-384.

MeSH Terms

Conditions

Psychological Well-Being; Mental Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 30, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)