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

NCT07034885 | Not Yet Recruiting

• 1 other identifier: LokmanHekimU
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Menopause; Self-Efficacy; Quality of Life; Mindfulness

Outcome Measures

Primary Outcomes (3)

• Change in menopausal symptom severity

  The severity of menopausal symptoms will be measured using the Menopausal Symptoms Rating Scale. The scale covers psychological, urogenital, and somatic dimensions. The Likert-type scale, consisting of 11 items covering menopausal complaints, includes options for each item: 0: None at all, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe. The total scale score is calculated based on the scores given for each item. The minimum possible score is 0, while the maximum is 44. A higher score indicates both an increase in the severity of menopausal symptoms and a negative impact on quality of life.

  Pre-intervention, post-intervention (week 8), follow-up (week 12)

• Change in quality of life

  Quality of life will be assessed with the Menopause-Related Quality of Life Scale (MENQOL). The scale includes vasomotor, psychosomatic, psychological and sexual life subscales. As the scores increase, the severity of the problems experienced increases. Lower scores indicate higher quality of life. On the MÖYKÖ-II, each subdomain score is ranked from 0 to 6. Women are asked to answer "no" or "yes" regarding any complaints they have experienced in the past month. If the answer is "yes," the participant scores each symptom on a scale of 0-6, indicating its presence. A "none" indicates that the symptom is not experienced, a "none" indicates that the symptom is present, and scores of 1-6 indicate the severity and increasing severity of the problem. The researcher scores each item on a scale of 1 to 8, including "none" and "none." The minimum score for each item is 1, and the maximum is 8. The minimum score for the total scale is 29, and the maximum is (29X8) 232.

  Pre-intervention, post-intervention (8th week), follow-up (12th week)

• Change in self-efficacy level

  Women's self-efficacy perceptions will be measured using the General Self-Efficacy Scale (GSES). The GSES is a 17-item Likert-type scale with a minimum score of 17 and a maximum score of 85. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17 are reverse-scored. Higher scores indicate higher self-efficacy beliefs. The scale consists of three subscales: initiation, perseverance, and persistence.

  Pre-intervention, post-intervention (8th week), follow-up (12th week)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Mindfulness-Based Self-Efficacy Development Program

Control Group

NO INTERVENTION

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.

Interventions

Mindfulness-Based Self-Efficacy Development Program BEHAVIORAL

"Mindfulness-Based Self-Efficacy Development Program" is a unique intervention model that integrates mindfulness-based practices with self-efficacy theory, structured for postmenopausal women. With the implementation of this research, a holistic and evidence-based intervention model will be presented for physical, psychological and social problems frequently encountered in the postmenopausal period. This program processes mindfulness-based skills such as observing thoughts, body awareness, regulating emotions, coping with stress and developing self-compassion in the axis of self-efficacy development with 8-week structured sessions. In this context, it is anticipated that the study will contribute to scientific knowledge and practices. In addition, the "Mindfulness-Based Self-Efficacy Development Program" developed in the study aims not only at symptom management, but also at increasing the individual's perception of control over their own lives, recognizing their internal resources and

Intervention Group

Eligibility Criteria

• Age: 45 Years - 57 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nurcan Gökgöz: lead

Study Sites (1)

Lokman Hekim Univeristy

Ankara, Çankaya, 06510, Turkey (Türkiye)

Location

Study Officials

• Didem Şimşek Küçükkelepçe, Assoc. Prof. Dr.

  Lokman Hekim University, Institute of Health Sciences, Department of Midwifery

  STUDY DIRECTOR

Central Study Contacts

Nurcan Gökgöz, PhD student

CONTACT

+90 312 444 8 548; nurcan.hilalay55@gmail.com

Didem Şimşek Küçükkelepçe, Assoc. Prof. Dr.

CONTACT

+90 312 444 8 548; didemkucukkelepce@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this study, blinding could not be done due to the nature of the study. Since the intervention program will be carried out directly by the researcher, the participants and the researcher will know which group is the intervention and which is the control group. However, in order to ensure impartiality in the data analysis process, the obtained data will be coded (Group 1-Group 2) and forwarded to an independent statistician and the statistical analyses will be performed by this expert without knowing the groups. Thus, it was aimed to prevent biases that may occur during the analysis phase by blinding the statistician.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: nurse

Model Details: This study is conducted with a randomized controlled, parallel group intervention model. Participants were divided into two groups, intervention and control groups, by simple randomization. The intervention group will be administered an 8-week Mindfulness-Based Self-Efficacy Development Program. The control group will not receive any intervention. Data from both groups will be collected with the same measurement tools before the program, at the end of the program (week 8), and 4 weeks after the end of the program.

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: September 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 28, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data sharing will begin 6 months after the completion of the study and publication of the results.
• Access Criteria: IPD data will only be accessible to researchers who have ethics committee approval, are conducting scientific research on relevant topics, and whose data use purpose has been clearly stated.

Locations

TU (1)