Effect Of Awareness and Occupatıonal Practıces On Menopausal Women's Psychologıcal Wellbeıng And Menopausal Symptoms (Mindfulness)

Kafkas University

Status: Active, not recruiting

Conditions: Psychological Well-Being; Occupational Therapy; Menopause; Mindfulness Meditation

Treatments: Behavioral: Mindfulness Based Practices; Behavioral: Occupational Practices; Behavioral: Mindfulness-Based Occupational Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT06749067

KafkasÜ-safak-36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Experiment 1 Group: Mindfulness Based Practices

Experimental group

Description:

Experiment 1 Group Intervention: In the first session preparation session; face-to-face meeting with the women in the experimental group and then general information about the definition, purpose and applications of the mindfulness-based practice will be given, and the lack of information about the practice, if any, will be eliminated by receiving feedback from the women. The importance of regular and timely participation in the application will be emphasised, application days will be determined and phone numbers will be taken to contact women for online applications. Then, the pre-test data consisting of Personal Information Form, Psychological Well-Being Scale, Menopause Symptoms Assessment Scale will be filled out by obtaining voluntary consent.

Treatment:

Behavioral: Mindfulness Based Practices

Experiment 2 Group: Occupational Practices

Experimental group

Description:

Experiment 2 Group Intervention: In the first session preparation session, the women in the experimental group will be introduced face-to-face and then general information will be given about the definition, purpose and applications of the occupational practice, and the lack of information about the practice will be eliminated by receiving feedback from the women. The importance of regular and timely participation in the application will be emphasised, application days will be determined and phone numbers will be taken to contact women for online applications. Then, the pre-test data consisting of Personal Information Form, Psychological Well-Being Scale, Menopause Symptoms Assessment Scale will be filled out by obtaining voluntary consent.

Treatment:

Behavioral: Occupational Practices

Experiment 3 Group: Mindfulness-Based Occupational Practice

Experimental group

Description:

Experiment 3 Group Intervention: In the first session preparation session, the women in the experimental group will be introduced face-to-face and then general information will be given about the definition, purpose and applications of the occupational practice, and the lack of information about the practice will be eliminated by receiving feedback from the women. The importance of regular and timely participation in the application will be emphasised, application days will be determined and phone numbers will be taken to contact women for online applications. Then, the pre-test data consisting of Personal Information Form, Psychological Well-Being Scale, Menopause Symptoms Assessment Scale will be filled out by obtaining voluntary consent. In the first session, before starting the Mindfulness-Based Engagement Practice, women will be focused on the moment with a 3-minute breathing exercise, followed by a raisin exercise.

Treatment:

Behavioral: Mindfulness-Based Occupational Practice

Control Group

No Intervention group

Description:

Control Group: Telephone numbers will be taken to communicate with menopausal women who meet the inclusion criteria for the study. Then, the pre-test data consisting of Personal Information Form, Psychological Well-Being Scale, Menopause Symptoms Assessment Scale will be filled out by obtaining voluntary consent. No treatment will be applied to women in this group. At the end of 8 weeks, all participants will be asked to complete the Personal Information Form, Psychological Well-Being Scale, Menopause Symptoms Assessment Scale as a post-test application.