Clinical trial NCT06749067: Effect Of Awareness and Occupatıonal Practıces On Menopausal Women's Psychologıcal Wellbeıng And Menopausal Symptoms
Official title: The Effect Of Mındfulness-Based and Occupatıonal Practıces On Psychologıcal Well-Beıng and Menopausal Symptoms In Menopausal Women: A Randomısed Controlled Trıal
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mindfulness Meditation
Occupational Therapy
Psychological Well-Being
Menopause
Keywords: Mindfulness
Nurse
Menopause
Occupational Practices
Psychological Well-Being
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women will be divided into three experimental and one control group by lottery method from the selected family health centre. All participants will first be informed about the intervention application and informed consent will be obtained. Afterwards, all participants will be asked to fill out the Personal Information Form, Psychological Well-Being Scale, Menopause Symptoms Assessment Scale as a pre-test application.

As an intervention programme, no treatment will be applied to the women in the control group, Mindfulness-Based Practices for the women in the experimental 1 group, Engagement Practice for the experimental 2 group, and Mindfulness-Based Occupational Practice for the experimental 3 group were planned as 2 sessions per week for 8 weeks and 16 sessions of 45-60 minutes.
Primary purpose: PREVENTION

Brief summary: Non-drug methods are frequently preferred in menopausal symptoms, especially in mental effects, and their effectiveness on symptoms is remarkable. Non-drug methods mainly used in the management of postmenopausal symptoms are sports, avoiding bad habits, paying attention to diet and increasing fluid intake, wearing comfortable clothes. In addition, there are many supportive methods such as stress reduction meditation practices, garden therapies, breathing and physical exercise practices, aromatherapy. Among the most frequently used coping methods of women experiencing menopausal symptoms such as irritability and anxiety/anxiety, it was found that 'paying attention to different things (housework, cleaning, cooking, handicrafts, etc.)' was among the most frequently used coping methods. In this direction, it is thought that occupational practice may have positive effects on menopausal symptoms in women. Engagement practices are one of the methods widely used in recent years to cope with anxiety, depression and stress.

Our study aimed to measure the effectiveness of mindfulness-based practices on menopausal symptoms and psychological well-being in menopausal women by blending mindfulness-based practices and busyness practices, and in this sense, it is anticipated that it will make a significant contribution to the literature.

Objective: This study will be conducted to determine the effect of mindfulness-based and occupational practices on psychological well-being and menopausal symptoms in menopausal women.

Materials and Methods: The research will be conducted as a randomised controlled experimental study in a four-group, parallel, pretest-posttest design. The research is planned to be conducted between December 2024 and December 2025. The population of the study consists of women in menopause who applied to the ASM in the centre of Kars between December 2024 and December 2025. The sample of the study will consist of women who meet the inclusion criteria among these women. As a result of the power analysis performed in the G\*Power version 3.1.9.7 programme, it was determined that a total of 76 participants, at least 19 people in each of the intervention and control groups, with a sample size, 95% confidence, 95% test power (1-ß), 0.05% margin of error level, d = 0.25 effect size (Kang, 2021). Considering 10% possible data loss in the study, it was planned to include 20 women in each of the intervention and control groups.

Detailed description: The transition from the reproductive period to post-reproductive life in women is called menopausal transition and is an important turning point in a woman's life cycle. Most women experience menopausal symptoms during this period and the majority of these symptoms are severe and long-lasting. Vasomotor symptoms in women can disrupt sleep, cause forgetfulness and fatigue, as well as mental changes, increase anxiety and create conditions such as depressive mood.

Non-drug methods are frequently preferred in menopausal symptoms, especially in mental effects, and their effectiveness on symptoms is remarkable. Non-drug methods mainly used in the management of postmenopausal symptoms are sports, avoiding bad habits, paying attention to diet and increasing fluid intake, wearing comfortable clothes. In addition, there are many supportive methods such as stress reduction meditation practices, garden therapies, breathing and physical exercise practices, aromatherapy. Among the most frequently used coping methods of women experiencing menopausal symptoms such as irritability and anxiety/anxiety, it was found that 'paying attention to different things (housework, cleaning, cooking, handicrafts, etc.)' was among the most frequently used coping methods. In this direction, it is thought that occupational practice may have positive effects on menopausal symptoms in women. Engagement practices are one of the methods widely used in recent years to cope with anxiety, depression and stress.

Our study aimed to measure the effectiveness of mindfulness-based practices on menopausal symptoms and psychological well-being in menopausal women by blending mindfulness-based practices and busyness practices, and in this sense, it is anticipated that it will make a significant contribution to the literature.

Objective: This study will be conducted to determine the effect of mindfulness-based and occupational practices on psychological well-being and menopausal symptoms in menopausal women.

Materials and Methods: The research will be conducted as a randomised controlled experimental study in a four-group, parallel, pretest-posttest design. The research is planned to be conducted between December 2024 and December 2025. The population of the study consists of women in menopause who applied to the ASM in the centre of Kars between December 2024 and December 2025. The sample of the study will consist of women who meet the inclusion criteria among these women. As a result of the power analysis performed in the G\*Power version 3.1.9.7 programme, it was determined that a total of 76 participants, at least 19 people in each of the intervention and control groups, with a sample size, 95% confidence, 95% test power (1-ß), 0.05% margin of error level, d = 0.25 effect size (Kang, 2021). Considering 10% possible data loss in the study, it was planned to include 20 women in each of the intervention and control groups.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research,
* Knowing how to read and write Turkish,
* Do not be in menopause,
* Having a smart mobile phone,

Exclusion Criteria:

* Don't take hormone therapy,
* The presence of a diagnosed psychiatric illness,
* Visual, hearing, speech, physical or mental disability,
* Interruption of the application made within the scope of Engagement Practices,
* Taking psychiatric medication (antidepressants, benzodiazepines, hypnotics, narcotics, etc.), Using any other CAM method (such as Reiki, phytoestrogens, acupressure).

Primary outcomes:
measure: Psychological Well-Being Scale
timeFrame: Eight weeks
measure: The menopause Rating Scale (MRS)
timeFrame: Eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Kafkas University
Study officials:
affiliation: Kafkas University
name: Şafak Aydin, ASSISTANT PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Telef, B.B. (2013). Psikolojik iyi oluş ölçeği: Türkçeye uyarlama, geçerlik ve güvenirlik çalışması. Hacettepe Üniversitesi Eğitim Fakültesi Dergisi, 28(28-3), 374-384.
citation: Gürkan, Ö.C. (2005). Menopoz semptomları değerlendirme ölçeğinin Türkçe formunun güvenirlik ve geçerliliği. Hemşirelik Forumu Dergisi, 3, 30-5.