An interventional study of Components of Nurse-Led Menopause Self- Management Box in Postmenopausal Flushing and Postmenopausal Symptoms, sponsored by Mansoura University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Mansoura University · Not applicable, Interventional, and Supportive care
Aim of the study This study aims to evaluate the effect of a nurse-led menopause self-management box on hot flash frequency and menopause-specific quality of life among postmenopausal women.
Research hypotheses
Introduction Menopause is a natural biological transition that marks the end of a woman's reproductive years and results from the loss of ovarian follicular function and a decline in circulating estrogen levels. Natural menopause is clinically recognized after 12 consecutive months of amenorrhea in the absence of another physiological, pathological, or medical cause (World Health Organization [WHO], 2024). Although menopause most commonly occurs between the ages of 45 and 55 years, the timing and experience of the menopausal transition vary considerably among women. The transition may extend over several years and may affect women's physical, psychological, emotional, and social well-being (Gombert-Labedens, Vesterdorf, Fuller, Maloney \& Baker, 2025).
Vasomotor symptoms (VMS), particularly hot flashes and night sweats, are one of the most common symptoms of the menopausal transition. Hot flashes are generally described as sudden sensations of intense heat, commonly involving the face, neck, and chest, and may be accompanied by sweating, palpitations, chills, and anxiety. It has been estimated that approximately 50% to 80% of women experience vasomotor symptoms during the menopausal transition, although their frequency, severity, duration, and associated distress differ substantially among women and across cultural and demographic groups (Crandall, Mehta \& Manson, 2023; Khan, Kapoor, Faubion \& Kling, 2023).
Hot flashes are among the most bothersome menopausal symptoms and are a common reason for seeking menopause-related healthcare. The frequency and severity of hot flashes vary, but they can interfere with sleep, daily activities, concentration, emotional stability, social interactions, and work productivity. They may also contribute to fatigue and psychological distress, thereby reducing women's overall quality of life. Evidence indicates that vasomotor symptoms may persist for a median duration of approximately seven years, while women who begin experiencing them during perimenopause may continue to experience them for a longer period (Crandall et al., 2023; Khan et al., 2023). Effective management of VMS is crucial for improving the quality of life during menopause (Fasero et al., 2025).
Menopausal hormone therapy is considered the most effective treatment for bothersome vasomotor symptoms. Nevertheless, it may not be suitable for every woman because of medical contraindications, concerns about potential risks, personal preferences, or limited access to specialized menopause services. Therefore, evidence-based nonhormonal interventions are particularly important for women who are unable or unwilling to use hormone therapy. Recommended nonhormonal approaches include menopause-specific cognitive behavioral therapy, clinical hypnosis, certain pharmacological therapies, and weight reduction for some women. Treatment decisions should be individualized according to symptom severity, health status, contraindications, and women's preferences (Shufelt et al., 2023).
Self-management is particularly relevant to menopause care because it encourages women to take an active role in understanding, monitoring, and managing their symptoms. Menopause education can improve women's understanding of the menopausal transition, facilitate the adoption of symptom-management strategies, and contribute to improved symptom control and quality of life (Keye, Varley, \& Patton, 2023; McFeeters, Pedlow, McGinn, \& McConnell, 2024). A systematic review and meta-analysis found that menopause education was associated with statistically significant improvements in quality of life and symptom control. However, the authors identified variations in intervention content, follow-up periods, and methodological quality, indicating the need for further well-designed intervention studies (Keye et al., 2023).
More recent evidence supports the use of healthcare professional-led menopause education. A randomized controlled longitudinal study demonstrated that a structured, four-week, midwife-led education program significantly reduced menopausal symptom severity and improved menopause-specific quality of life compared with routine follow-up. The beneficial effects were sustained at the six-month follow-up. This finding supports the potential value of structured professional guidance, continued follow-up, and individualized support during the menopausal transition (Benli et al., 2026).
Nurses play a vital role in delivering these interventions through health education, symptom assessment, behavioral support, follow-up, and referral. Previous nurse-led programs have demonstrated improvements in women's knowledge and self-reported menopause-management practices (Sunny \& Raman, 2019), while other evidence suggests that education and support delivered within nurse-led menopause services may improve menopausal symptoms and quality of life (Keye, 2025). However, some available studies have used small samples or interventions that combined education with medical treatment, limiting the ability to isolate the independent effect of the nurse-led educational component (Keye, 2025; Sunny \& Raman, 2019).
Despite growing evidence supporting menopause education and professionally guided behavioral interventions, evidence remains limited regarding structured, nurse-led, home-based self-management interventions that integrate symptom monitoring, individualized behavioral support, and continued follow-up. In particular, the effectiveness of delivering these components through a standardized self-management box has not been adequately examined among community-dwelling postmenopausal women in Egypt. Therefore, the present study aims to evaluate the effect of a nurse-led menopause self-management box on hot flash frequency and menopause-specific quality of life among postmenopausal women experiencing hot flashes.
Aim of the study This study aims to evaluate the effect of a nurse-led menopause self-management box on hot flash frequency and menopause-specific quality of life among postmenopausal women.
293 studies on the registry are indexed under Hot Flashes; 52 are open to participants now.
This study's planned enrollment of 120 is above the median of 90 across 262 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women will be eligible to participate if they:
Exclusion Criteria:
Have experienced surgical or treatment-induced menopause, including menopause resulting from bilateral oophorectomy, chemotherapy, or radiotherapy.
Components of Nurse-Led Menopause Self- Management Box The nurse-led menopause self-management box will contain a set of educational and practical materials designed to help menopausal women monitor and manage hot flashes in their daily lives. The box will include an illustrated Arabic-language booklet providing simple information about menopause, hot flashes, common triggers, and recommended lifestyle and self-management strategies. It will also contain a seven-day hot flash diary for recording the frequency, timing, severity, and possible triggers of each hot flash, together with a personal action plan to help each participant identify suitable strategies for symptom management. Practical cooling items, including a handheld fan, a cooling towel, and a reusable water bottle, will be provided to facilitate immediate cooling and adequate hydration. In addition, the box will include relaxation and paced-breathing instruction cards, a sleep hygiene checklist, and a healthy lifestyle guid
Other: Components of Nurse-Led Menopause Self- Management Box
The nurse-led menopause self-management box will contain a set of educational and practical materials designed to help menopausal women monitor and manage hot flashes in their daily lives. The box will include an illustrated Arabic-language booklet providing simple information about menopause, hot flashes, common triggers, and recommended lifestyle and self-management strategies. It will also contain a seven-day hot flash diary for recording the frequency, timing, severity, and possible triggers of each hot flash, together with a personal action plan to help each participant identify suitable strategies for symptom management. Practical cooling items, including a handheld fan, a cooling towel, and a reusable water bottle, will be provided to facilitate immediate cooling and adequate hydration. In addition, the box will include relaxation and paced-breathing instruction cards, a sleep hygiene checklist, and a healthy lifestyle guide covering diet, physical activity, clothing choices, ca
Hot Flash Frequency and Menopause-Specific Quality of Life
Three tools will be used for data collection: Tool II: A Seven-Day Hot Flash Diary A seven-day hot flash diary, adapted from the diary described by Guttuso, DiGrazio, and Reddy (2012), will be used to assess hot flash frequency and severity at baseline and during the final week of the intervention. Participants will be instructed to record each hot flash at or as soon as possible after its occurrence over seven consecutive days and classify its severity according to the extent of sweating and interference with usual activities. A mild hot flash will be defined as a sensation of heat without sweating or interference with usual activities. A moderate hot flash will be defined as a sensation of heat accompanied by sweating, while the woman remains able to continue her usual activities. A severe hot flash will be defined as a sensation of heat accompanied by sweating that causes interruption of usual activities. A very severe hot flash will be defined
Time frame: max 5-6 months
Quality of Life Questionnaire
Tool III: Menopause-Specific Quality of Life Questionnaire The Menopause-Specific Quality of Life Questionnaire (MENQOL), originally developed by Hilditch et al. (1996), will assess menopause-specific quality of life among participating women. The MENQOL is a 29-item, menopause-specific, self-reported questionnaire comprising four domains: the vasomotor domain (3 items); the psychosocial domain (7 items); the physical domain (16 items); and the sexual domain (3 items). The one-week recall version of the MENQOL will be used in the present study. Participants will be asked whether they have experienced each symptom during the preceding week. If a symptom has been experienced, they will indicate how bothersome it was on a scale ranging from 0, indicating "not at all bothered," to 6, indicating "extremely bothered." Responses will be converted into scores ranging from 1 to 8 according to the authorized scoring instructions. A score of 1 indicates that the symptom was not experienced, a sc
Time frame: max 5-6 months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Start is estimated for Oct 2026; primary completion for May 2027, 6 months later.
Of 48 non-industry interventional studies with no phase under Hot Flashes, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 47. This study's planned 6 months is below that.
Counting every sponsor, half of 54 studies reached it within 22 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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