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Postmenopausal FlushingSelf-ManagemenNCT07874893

Self-Management Box on Hot Flash in Postmenopausal Women

A study testing Components of Nurse-Led Menopause Self- Management Box in people with Postmenopausal Flushing and Postmenopausal Symptoms, run by Mansoura University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older, women only
What is being tested?
Components of Nurse-Led Menopause Self- Management Box
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteEgypt
Study dates
8 Oct 2026to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women will be eligible to participate if they:
  • Are aged 45-60 years.
  • Have experienced natural menopause, defined as amenorrhea for at least 12 consecutive months without another physiological, pathological, or treatment-related cause.
  • Report recurrent and bothersome hot flashes during the preceding two weeks.
  • Are residing in Mansoura City during the study period.
  • Have access to a telephone, either personally or through an authorized household member, for scheduled follow-up.
  • Are willing to receive the nurse-led menopause self-management box and adhere to the planned intervention and follow-up schedule.
  • Are willing to participate voluntarily and provide informed consent.

Who cannot join

  • • Have experienced surgical or treatment-induced menopause, including menopause resulting from bilateral oophorectomy, chemotherapy, or radiotherapy.
  • Are currently receiving menopausal hormone therapy or prescribed nonhormonal medication specifically for vasomotor symptoms.
  • Have initiated, discontinued, or changed any treatment likely to affect vasomotor symptoms during the previous three months.
  • Have uncontrolled medical conditions that may cause symptoms similar to hot flashes, such as uncontrolled thyroid disorders.
  • Have severe cognitive, psychiatric, hearing, communication, or physical impairment that would prevent comprehension of the intervention or completion of study assessments.
  • Are currently participating in another structured menopause education or symptom-management program.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abeer SA Ali, Lecturer contact

+201097536907

dr_abeer_salah@mans.edu.eg

Doaa Mo Zein-Elabdeen, Lecturer contact

+201092847845

doaamh2018@Mans.edu.eg

Egypt1 site
  • Faculty of Nursing

    Al Mansurah, Egypt, 35516

    abeer Sa Ali, lecturer, +201097536907, dr_abeer_salah@mans.edu.eg

    Doaa Mo Zein El abdeen, Lecturer, +201092847845, doaamh2018@mans.edu.eg

Other trials in Egypt

About this study

Official title: Effect of a Nurse-Led Menopause Self-Management Box on Hot Flash Frequency and Menopause-Specific Quality of Life Among Postmenopausal Women

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

  • Postmenopausal women who receive the nurse-led menopause self-management box will demonstrate significantly lower mean daily hot flash frequency immediately after the four-week intervention and at the three-month follow-up compared with baseline.
  • Postmenopausal women who receive the intervention will demonstrate significantly lower hot flash severity immediately after the four-week intervention and at the three-month follow-up compared with baseline.
  • Postmenopausal women who receive the intervention will demonstrate significantly lower MENQOL scores, indicating improved menopause-specific quality of life, immediately after the four-week intervention and at the three-month follow-up compared with baseline.
Read the detailed description

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.

Being tested
Components of Nurse-Led Menopause Self- Management Box
Keywords
Postmenopausal, hot flash, QoL, Nurse-Led
Medical subject headings
Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Components of Nurse-Led Menopause Self- Management BoxOther

    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

Study groups in NCT07874893
Study groupRoleWhat they receive
Intervention: Nurse-Led Menopause Self- Management BoxExperimentalComponents 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
Receives: Other: Components of Nurse-Led Menopause Self- Management Box

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: max 5-6 months

Secondary outcomes (1)
  1. 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

    Measured: max 5-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study start8 Oct 2026 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
A quasi-experimental one-group pretest-posttest study follow-up research design will be used. This design was selected to assess changes in the study outcomes within the same group before and after implementation of the intervention (Flanagan \& Beck, 2024).
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07874893
Sponsor's protocol ID
Self-Management Box Hot Flash
Acronym
Self-Managemen
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Fasero M, Sanchez M, Baquedano L, Gippini I, Fuentes D, Navarro C, Beltran E, Lilue M, Porcel I, Pingarron C, Herrero M, Romero P, Ortega T, Carretero E, Palacios S, Mendoza N, Coronado PJ. Management of menopausal hot flushes. Recommendations from the Spanish Menopause Society. Eur J Obstet Gynecol Reprod Biol X. 2025 Jan 23;25:100366. doi: 10.1016/j.eurox.2025.100366. eCollection 2025 Mar.

    PubMed 39944633
  • Crandall CJ, Mehta JM, Manson JE. Management of Menopausal Symptoms: A Review. JAMA. 2023 Feb 7;329(5):405-420. doi: 10.1001/jama.2022.24140.

    PubMed 36749328
  • Benli TE, Atabey K, Aksoy Derya Y. The effect of a midwife-led education program on menopause symptom severity and menopause-specific quality of life: a randomized controlled longitudinal study. Menopause. 2026 Jun 1;33(6):702-710. doi: 10.1097/GME.0000000000002724.

    PubMed 41556850

Questions about this trial

What is this clinical trial studying?

A study testing Components of Nurse-Led Menopause Self- Management Box in people with Postmenopausal Flushing and Postmenopausal Symptoms, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abeer SA Ali, Lecturer (+201097536907, dr_abeer_salah@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hot Flash Frequency and Menopause-Specific Quality of Life (time frame: max 5-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07874893, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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