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

NCT06749067 | Active Not Recruiting

• 1 other identifier: KafkasÜ-safak-36
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Mindfulness; Nurse; Menopause; Occupational Practices; Psychological Well-Being

Outcome Measures

Primary Outcomes (2)

• Psychological Well-Being Scale

  The scale developed by Dinner in 2009 to measure the level of psychological well-being is a 7 Likert scale consisting of 8 items. The Turkish validity and reliability of the scale was conducted in 2013. Psychological Well-being Scale defines important elements of human functioning such as positive relationships, self-efficacy perception, having a meaningful and purposeful life. The score obtained from the scale varies between 8-56. A high score indicates that the person has many psychological resources and strengths. Cronbach's alpha coefficient of the scale was found to be 0.80.

  Eight weeks

• The menopause Rating Scale (MRS)

  MSDS was developed by Schneider et al. in 1992. Turkish validity and reliability study was conducted in 2005. The CDSS consists of 11 items and 3 sub-dimensions. The sub-dimensions are named as 'Somatic Complaints', 'Psychological Complaints', 'Urogenital Complaints'. The scale is answered in 5-point Likert scale and each statement is scored as 0: None, 1: Mild, 2: Moderate, 3: Severe and 4: Very severe. The lowest score that can be obtained from the whole scale is 0 and the highest score is 44. An increase in the total score obtained from the scale indicates an increase in the severity of the complaints experienced and a negative impact on the quality of life. The cronbach alpha reliability coefficient of the original scale is 0.84. The cronbach alpha values of the subgroups are 0.65 for somatic complaints, 0.79 for psychological complaints and 0.72 for urogenital complaints.

  Eight weeks

Study Arms (4)

Experiment 1 Group: Mindfulness Based Practices

EXPERIMENTAL

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.

Behavioral: Mindfulness Based Practices

Experiment 2 Group: Occupational Practices

EXPERIMENTAL

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.

Behavioral: Occupational Practices

Experiment 3 Group: Mindfulness-Based Occupational Practice

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Occupational Practice

Control Group

NO INTERVENTION

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.

Interventions

Mindfulness Based Practices BEHAVIORAL

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. In the first session, before starting the Awareness Practice, women will be focused on the moment with a 3-minute breathing exercise and then continue with the raisin exercise.

Also known as: Mindfulness

Experiment 1 Group: Mindfulness Based Practices

Occupational Practices BEHAVIORAL

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. Before starting the Busyness Practice, women will be asked to choose the practice that they can do within the scope of the busyness practice such as 'hand knitting, wood painting, charcoal, origami, bead work, jewellery design, painting tables with

Also known as: Occupational Therapy

Experiment 2 Group: Occupational Practices

Mindfulness-Based Occupational Practice BEHAVIORAL

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.

Also known as: Mindfulness-Based, Occupational Therapy

Experiment 3 Group: Mindfulness-Based Occupational Practice

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Kafkas University

Kars, 36100, Turkey (Türkiye)

Location

Related Publications (2)

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

  BACKGROUND

• Gürkan, Ö.C. (2005). Menopoz semptomları değerlendirme ölçeğinin Türkçe formunun güvenirlik ve geçerliliği. Hemşirelik Forumu Dergisi, 3, 30-5.

  BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Mindfulness; Occupational Therapy

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Şafak Aydin, ASSISTANT PROFESSOR

  Kafkas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: December 1, 2024
• Primary Completion: August 2, 2025
• Study Completion: December 31, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)