Effects of Mindfulness-Based Self-Efficacy Development Program on Postmenopausal Women (MOPKA)

Nurcan Gökgöz

Status: Not yet enrolling

Conditions: Quality of Life; Menopausal Symptoms; Postmenopausal Period; Self-Efficacy; Stress Management

Treatments: Behavioral: Mindfulness-Based Self-Efficacy Development Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07034885

LokmanHekimU

Details and patient eligibility

About

The aim of this randomized controlled clinical trial is to evaluate the effects of a mindfulness-based self-efficacy development program on menopausal symptoms and quality of life in postmenopausal women. The main questions it aims to answer are:

Does the mindfulness-based program reduce the severity of menopausal symptoms?

Does the mindfulness-based program improve the quality of life of postmenopausal women?

Does the mindfulness-based program significantly increase participants' overall self-efficacy?

The researchers will compare whether there are differences between the mindfulness-based training program applied to the intervention group and the control group in terms of menopausal symptoms, quality of life, and self-efficacy scores.

The main tasks that will be asked of the participants are as follows:

Those in the intervention group will participate in a face-to-face mindfulness-based self-efficacy development program, each session lasting at least 120 minutes, once a week for 8 weeks, with a maximum of 10 people per group.

The control group will not receive any intervention.

Participants in both groups will be evaluated with a personal information form and measurement tools such as the Menopause Symptoms Assessment Scale, the Menopause Specific Quality of Life Scale, and the General Self-efficacy Scale.

Full description

This research is a randomized controlled experimental study aiming to evaluate the effects of a mindfulness-based self-efficacy development program on menopausal symptoms and quality of life in women during menopause. The research will be conducted at Lokman Hekim University Etlik Hospital between September 2025 and March 2026.

Postmenopausal women who have entered menopause naturally, who do not have a physical disability that prevents them from participating in mindfulness practices, who are literate and literate in Turkish, and who have access to technology will be included in the study. Participants will be assigned to the intervention and control groups by simple randomization.

Participants in the intervention group will receive an eight-week mindfulness-based self-efficacy development training based on Kabat-Zinn's Mindfulness-Based Stress Reduction (MBSR) program. Sessions will be held face-to-face once a week for 90-120 minutes. The program consists of components such as breath awareness, focusing on bodily sensations, mindful movement, working with emotions, and present-moment awareness.

Standard scales will be applied to all participants before and after the study to assess menopausal symptoms, quality of life and general self-efficacy levels. The collected data will be compared statistically.

This study aims to be an original study to evaluate whether a mindfulness-based self-efficacy development program has the potential to help control menopausal symptoms and improve quality of life in postmenopausal women.

Enrollment: 70 estimated patients

Sex: Female

Ages: 45 to 57 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion criteria:

• Individuals who are in the +1a or +1b substage of early postmenopause according to the STRAW+10 system (at least 12 months and at most 24 months have passed since their last menstrual period)
• Are proficient in reading and writing Turkish
• Are in a spouse or partner
• Have entered menopause naturally
• Do not have a physical disability such as a severe musculoskeletal disorder, neurological disease, or mobility limitation that would prevent the use of mindfulness techniques (e.g., seated meditation, breathing exercises, gentle body awareness exercises)
• Have not used MBSR techniques in the last six months
• Own a smartphone or internet-enabled device.

Exclusion criteria

• Those who completed the pretest data collection forms incompletely,
• Those who had any psychological disorder or experienced a traumatic event in the last two to one years,
• Those who received hormone replacement therapy during menopause,
• Those who had any gynecological cancer

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Intervention Group

Experimental group

Description:

In the Mindfulness-Based Self-Efficacy Development Program, it is planned that the training groups will consist of a maximum of 10 people. The trainings will be structured as 90-120 minute sessions, 1 day a week, for a total of 8 weeks. Each session will be carried out through face-to-face training. The program content is structured based on Kabat-Zinn's Mindfulness-Based Stress Reduction (MBSR) protocol. The program focuses on breath awareness, focusing on bodily sensations, moving with awareness, eating with awareness and mindfulness in daily activities, coping with thoughts, emotions and stressful situations with awareness, and the present moment as a safe space within the framework of the basic components of self-compassion, intention and attitude. Each session will include story content appropriate to the main theme of the session. The trainings applied to the intervention group were prepared within the scope of the "Mindfulness-Based Self-Efficacy Development Program" and the co

Treatment:

Behavioral: Mindfulness-Based Self-Efficacy Development Program

Control Group

No Intervention group

Description:

The participants in the control group will be administered the measurement tools applied to the intervention group at the beginning of the study. At the end of the 8-week follow-up period, the same scales applied in the pre-test will be re-administered and interim test data will be collected. Thus, the level of change in the control group will be evaluated comparatively with the intervention group. Following the completion of the 4-week home practice applications of the intervention group, post-test data will be collected from the control group. No intervention will be applied to the participants in the control group during the study. However, in accordance with ethical principles, the content program of the sixth week of the eight-week mindfulness training applied to the intervention group will be presented to the women in the control group after the study is completed. In addition, training brochures shared with the intervention group will be provided.