The Effect of a Meleis' Transition Theory-Based Education and Counseling Program on Menopausal Symptoms, Perimenopausal Depression, and Menopause-Specific Quality of Life in Menopausal Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Change in Perimenopausal Depression
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of a Meleis' Transition Theory-based education and counseling program on menopausal symptoms, perimenopausal depression, and menopause-specific quality of life among naturally menopausal women aged 45 to 55 years.
Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive a structured four-week education and counseling program based on Meleis' Transition Theory, supported by a secure online messaging group and follow-up counseling sessions. The control group will receive routine care and standard information during the study period and will be offered a one-day educational session after completion of the final assessment.
The outcomes will be measured at baseline and Week 16 using the Menopause Rating Scale, the Perimenopausal Depression Scale, and the Menopause-Specific Quality of Life Questionnaire-II.
详细描述
Menopause is a developmental life transition associated with biological, psychological, and social changes that may negatively affect women's health, well-being, and quality of life. During the menopausal transition, women may experience vasomotor symptoms, sleep disturbances, mood changes, depressive symptoms, urogenital symptoms, and difficulties in adapting to new life roles.
Meleis' Transition Theory provides a conceptual framework for understanding and supporting individuals during life transitions. The theory emphasizes the role of healthcare professionals in facilitating healthy transitions through education, counseling, support, and the strengthening of coping strategies.
This study is designed as a two-arm randomized controlled trial. The study population consists of naturally menopausal women registered at Dikmen Sokullu Mehmet Pasa Family Health Center, a primary healthcare institution affiliated with the Ankara Provincial Health Directorate in Turkey. A total of 114 women who meet the eligibility criteria and provide written informed consent will be recruited.
Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using computer-generated simple randomization through Randomizer.org. To minimize bias, statistical analyses will be conducted by a blinded statistician.
Participants in the intervention group will receive a Meleis' Transition Theory-Based Education and Counseling Program. The program consists of four weekly face-to-face educational sessions lasting approximately 90 minutes each. In addition, a secure WhatsApp support group will be established exclusively for participants in the intervention group to provide motivational support and ongoing communication. Follow-up counseling and support meetings will also be conducted during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
To minimize bias, statistical analyses will be conducted by a blinded statistician who will remain unaware of participant group assignments throughout the analysis process.
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 45 to 55 years
- •Naturally menopausal women
- •Menopause duration not exceeding 2 years
- •Experiencing menopausal symptoms
- •Sexually active
- •Able to read and write Turkish
- •Willing to participate voluntarily
- •Able to provide written informed consent
- •Not currently receiving hormone replacement therapy
- •No history of psychiatric disorders
- •No previous menopause-related education
排除标准
- •Failure to continue participation in the study
- •Failure to attend education and counseling sessions
- •Withdrawal from the study at any time
- •Withdrawal of informed consent
- •Loss to follow-up
研究组 & 干预措施
Meleis' Transition Theory-Based Education and Counseling Program
Participants assigned to the intervention group will receive a structured education and counseling program based on Meleis' Transition Theory. The intervention consists of four weekly face-to-face educational sessions lasting approximately 90 minutes each, a secure online messaging support group, continuous motivational support, and follow-up counseling sessions throughout the study period.
干预措施: Meleis' Transition Theory-Based Education and Counseling Program (Behavioral)
Standard Information Control
Participants assigned to the control group will receive routine care and standard information during the study period. Following completion of the Week 16 assessment, participants will be offered a one-day educational session based on the intervention content.
干预措施: Standard Information (Other)
结局指标
主要结局
Change in Perimenopausal Depression
时间窗: Baseline and Week 16
The Meno-D is a 12-item self-report scale developed to evaluate perimenopausal depressive symptoms. Items are scored on a 4-point Likert scale. Total scores range from 0 to 48, with higher scores indicating greater severity of perimenopausal depression. Scores of 20-24 indicate mild depression requiring follow-up, 24-32 indicate moderate depression requiring treatment, and scores ≥32 indicate severe depression requiring treatment
Change in Menopause-Specific Quality of Life
时间窗: Baseline and Week 16
The MENQOL-II is a 29-item instrument assessing the impact of menopausal symptoms on quality of life across vasomotor, psychosocial, physical, and sexual domains. Total scores range from 29 to 232, with higher scores indicating a greater negative impact of menopausal symptoms on quality of life.
次要结局
未报告次要终点
研究者
SENİHA BALCI CEBECİ
Research Assistant
Ankara Medipol University