Menopausal Symptoms, Postmenopausal Period, Quality of Life, Self-Efficacy, Stress Management
Conditions
Keywords
Menopause, Self-Efficacy, Quality of Life, Mindfulness
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.
Detailed 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.
Interventions
BEHAVIORALMindfulness-Based Self-Efficacy Development Program
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
Sponsors
Nurcan Gökgöz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 57 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in menopausal symptom severity | Pre-intervention, post-intervention (week 8), follow-up (week 12) | 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. |
| Change in quality of life | Pre-intervention, post-intervention (8th week), follow-up (12th week) | 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. |
| Change in self-efficacy level | Pre-intervention, post-intervention (8th week), follow-up (12th week) | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactNurcan Gökgöz, PhD student
Backup ContactDidem Şimşek Küçükkelepçe, Assoc. Prof. Dr.
Outcome results
None listed