The Effect of Laughter Therapy on Brain Fog, Psychological Well-Being, and Sleep Quality in Women During Menopause
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Introductory Information Form:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willingness to participate in the study
- •Ability to communicate
- •Having entered menopause within the last 3 years
- •Having experienced natural menopause
- •Being literate
排除标准
- •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
研究组 & 干预措施
Group 1 laughter yoga therapy
Participants received a total of 8 sessions of laughter yoga therapy, conducted twice weekly.
干预措施: grup 1 laughter yoga therapy (Other)
Group 2 Control
结局指标
主要结局
Introductory Information Form:
时间窗: Baseline
This form was developed by the researchers based on the literature and includes questions on participants' sociodemographic characteristics.
Brain Fog Scale
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
NURTEN ÖZÇALKAP
Asistant Professor
Agri Ibrahim Cecen University