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Completed

NCT Number: NCT07522840

Menopause, Laughter Therapy, and Well-Being

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.

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Key information

Conditions

Therapy Behavior Behavioral Symptoms Dyssomnias Fatigue Menopause Mental Disorders Mental Fatigue Nervous System Diseases Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms Sleep Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Women

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ağri İbrahim Çeçen Universty

Ağrı, Ağri, 04100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

grup 1 laughter yoga therapy

Other

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

Primary outcomes

  1. Introductory Information Form:

    Time frame: Baseline

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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Agri Ibrahim Cecen University

Other

Registry information

Official study title

The Effect of Laughter Therapy on Brain Fog, Psychological Well-Being, and Sleep Quality in Women During Menopause

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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