MenopausemindmenopausNCT06421909
Mindfulness-based Educational Intervention on Anxiety, Depression, Stress and Quality of Life on Menopausal Woman
A study testing mindfulness-based educational intervention in people with Menopause, run by Alexandria University at 1 site in Egypt.
Trial summary
Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- mindfulness-based educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Apr 2024to 28 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in age of menopause
Who cannot join
- age of menarche
- older than 70 years old
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university
Alexandria, Alexandria Governorate, 21913
mohamed H atta, 2026609088, mohamed-hussein@alexu.edu.com
About this study
Official title: Effect of Mindfulness-based Educational Intervention on Anxiety, Depression, Stress and Quality of Life on Menopausal Woman.
Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life.
Read the detailed description
Menopause is a significant transitional phase in a woman's life, often accompanied by various physical, emotional, and psychological challenges. Common issues during menopause include anxiety, depression, stress, and a decreased quality of life. Addressing these concerns holistically is crucial for improving overall well-being. Mindfulness-based educational interventions have gained recognition for their effectiveness in enhancing mental health and quality of life by promoting awareness and acceptance of present experiences. This study investigates the impact of a mindfulness-based educational intervention on anxiety, depression, stress, and quality of life in menopausal women.
- Conditions
- Menopause
- Being tested
- mindfulness-based educational intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based educational interventionBehavioural
Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based educational intervention group | Experimental | Not described Receives: Behavioral: mindfulness-based educational intervention |
| non-intervention group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
menopausal women who participate in the mindfulness-based educational intervention will experience significant reductions in anxiety inventory score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered
Measured: three months
Secondary outcomes (1)
menopausal women who participate in the mindfulness-based educational intervention will experience reductions in stress scale score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start18 Apr 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion28 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421909
- Sponsor's protocol ID
- 99-b
- Acronym
- mindmenopaus
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amin SM, El-Gazar HE, Zoromba MA, El-Sayed MM, Awad AGE, Atta MHR. Mindfulness for Menopausal Women: Enhancing Quality of Life and Psychological Well-Being Through a Randomized Controlled Intervention. J Nurs Scholarsh. 2025 Jul;57(4):563-575. doi: 10.1111/jnu.70003. Epub 2025 Feb 24.
PubMed 39992004
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness-based Educational Intervention on Anxiety, Depression, Stress and Quality of Life on Menopausal Woman.
- ClinicalTrials.gov ID
- NCT06421909
- Acronym / sponsor ID
- mindmenopaus / 99-b
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 28 Aug 2024 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life.
Detailed description
Menopause is a significant transitional phase in a woman's life, often accompanied by various physical, emotional, and psychological challenges. Common issues during menopause include anxiety, depression, stress, and a decreased quality of life. Addressing these concerns holistically is crucial for improving overall well-being. Mindfulness-based educational interventions have gained recognition for their effectiveness in enhancing mental health and quality of life by promoting awareness and acceptance of present experiences. This study investigates the impact of a mindfulness-based educational intervention on anxiety, depression, stress, and quality of life in menopausal women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based educational intervention group | Experimental | Behavioral: mindfulness-based educational intervention |
| non-intervention group | No intervention | – |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- in age of menopause
Key exclusion criteria (2 listed)
- age of menarche
- older than 70 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based educational interventionMindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life. | Behavioural | mindfulness-based educational intervention group |
Primary outcome
menopausal women who participate in the mindfulness-based educational intervention will experience significant reductions in anxiety inventory score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered
Time frame: three months
1 secondary outcome
menopausal women who participate in the mindfulness-based educational intervention will experience reductions in stress scale score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Derived from this study: PubMed 39992004Amin SM, El-Gazar HE, Zoromba MA, El-Sayed MM, Awad AGE, Atta MHR. Mindfulness for Menopausal Women: Enhancing Quality of Life and Psychological Well-Being Through a Randomized Controlled Intervention. J Nurs Scholarsh. 2025 Jul;57(4):563-575. doi: 10.1111/jnu.70003. Epub 2025 Feb 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based educational intervention in people with Menopause, run by Alexandria 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
menopausal women who participate in the mindfulness-based educational intervention will experience significant reductions in anxiety inventory score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered (time frame: three 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 NCT06421909, which also lists 1 linked publication.
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 20 May 2024.