Induced MenopauseNCT07884357
Nurse-Led Self-Compassion Intervention for Women With Induced Menopause
A study testing Nurse-Led Self-Compassion Intervention in people with Induced Menopause, run by Aya Ibrahim at 1 site in Egypt.
Trial summary
This study evaluated the effectiveness of a nurse-led self-compassion intervention on self-compassion, menopausal symptom severity, and self-esteem among women with medically induced menopause. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Induced Menopause
- What is being tested?
- Nurse-Led Self-Compassion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2026to 30 Jul 2026
- 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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 35-55 years.
- Women with medically induced menopause.
- Women experiencing menopausal symptoms.
- Women able to understand and communicate effectively.
- Women willing to participate in the study.
Who cannot join
- Women with a severe psychiatric disorder or cognitive impairment that could interfere with participation.
- Women currently receiving psychological or psychiatric treatment for a mental health disorder.
- Women with a medical or psychological condition that could interfere with participation in the intervention or assessment of study outcomes.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Menoufia University Cancer Institute
Shibīn al Kawm, Menoufia Governorate, 32861
About this study
Official title: Effectiveness of a Nurse-Led Self-Compassion Intervention on Self-Compassion, Menopausal Symptom Severity, and Self-Esteem Among Women With Induced Menopause
This study evaluated the effectiveness of a nurse-led self-compassion intervention on self-compassion, menopausal symptom severity, and self-esteem among women with medically induced menopause. A parallel-group randomized controlled trial was conducted among 150 women recruited from the outpatient clinics of the Cancer Institute, Menoufia University, Egypt. Participants were randomly assigned to an intervention group (75 women) or a routine-care control group (75 women). The intervention consisted of eight weekly group sessions lasting 45-60 minutes each. Outcomes were assessed before the intervention, immediately after the eight-week intervention, and at two-month follow-up using the Self-Compassion Scale, Rosenberg Self-Esteem Scale, and Menopause Rating Scale.
Read the detailed description
Study Design and Setting
A parallel-group randomized controlled trial with repeated assessments was conducted in the outpatient clinics of the Cancer Institute, Menoufia University, Egypt. The study included 150 women with medically induced menopause who met the eligibility criteria.
Participants and Allocation
Eligible women were recruited using purposive sampling. After eligibility assessment and written informed consent, participants were randomly allocated in a 1:1 ratio to the nurse-led self-compassion intervention group (n = 75) or the routine-care control group (n = 75). The allocation sequence was computer-generated and concealed using sequentially numbered, opaque, sealed envelopes.
Intervention
The intervention was delivered by the nurse researcher over eight consecutive weeks. Participants in the intervention group were divided into six subgroups of 12-13 women. Each subgroup attended one group session per week, with each session lasting approximately 45-60 minutes. Sessions incorporated psychoeducation, mindfulness training, emotional regulation strategies, self-kindness practices, self-esteem enhancement, and coping strategies for menopause-related challenges. Activities included reflective exercises, journaling, self-compassion letter writing, breathing exercises, body-awareness activities, and group discussions. The control group received routine care.
Outcome Assessment
Outcomes were assessed at three time points: baseline before the intervention (T0), immediately after completion of the eight-week intervention (T1), and two months after completion of the intervention (T2). The Self-Compassion Scale was used to assess self-compassion, the Rosenberg Self-Esteem Scale to assess self-esteem, and the Menopause Rating Scale to assess menopausal symptom severity.
Ethical Considerations
The study was conducted in accordance with the Declaration of Helsinki. Ethical approval was obtained from the Ethical and Research Committee of the Faculty of Nursing, Menoufia University (Approval No. ERCNMA 1000/4/1/190/26). Official authorization was obtained from the hospital director before commencement of the study. All participants provided written informed consent. Participation was voluntary, and participants were informed of their right to withdraw at any time without consequence. Participant anonymity and confidentiality were maintained through coded identifiers, and study data were securely stored with access restricted to authorized researchers.
- Conditions
- Induced Menopause
- Being tested
- Nurse-Led Self-Compassion Intervention
- Keywords
- Self-Compassion, Menopausal Symptoms, Self-Esteem, Nurse-Led Intervention, Mindfulness, Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Self-Compassion InterventionBehavioural
An eight-week nurse-led self-compassion intervention delivered through weekly group sessions lasting 45-60 minutes each. The sessions incorporated psychoeducation, mindfulness training, emotional regulation strategies, self-kindness practices, self-esteem enhancement, and coping strategies for menopause-related challenges.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Self-Compassion Intervention Group | Experimental | Participants in this group received an eight-week nurse-led self-compassion intervention consisting of one group session per week, with each session lasting 45-60 minutes. The sessions incorporated psychoeducation, mindfulness training, emotional regulation strategies, self-kindness practices, self-esteem enhancement, and coping strategies for menopause-related challenges. Activities included journaling, self-compassion letter writing, breathing exercises, body-awareness activities, and group discussions. Receives: Behavioral: Nurse-Led Self-Compassion Intervention |
| Routine-Care Control Group | No intervention | Participants in this group received routine care without the structured nurse-led self-compassion intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in menopausal symptom severity measured by the Menopause Rating Scale (MRS)
Menopausal symptom severity was assessed using the Menopause Rating Scale (MRS), an 11-item scale covering somato-vegetative, psychological, and urogenital symptoms. The total score ranges from 0 to 44, with higher scores indicating greater symptom severity. Changes in total MRS scores were evaluated between the intervention and routine-care control groups across the three assessment time points.
Measured: Baseline (T0), immediately after the 8-week intervention (T1), and 2-month follow-up (T2).
Secondary outcomes (2)
Change in self-compassion measured by the Self-Compassion Scale (SCS)
Self-compassion was assessed using the 26-item Self-Compassion Scale (SCS). Total scores range from 26 to 130, with higher scores indicating greater self-compassion. Changes in total SCS scores were evaluated between the intervention and routine-care control groups.
Measured: Baseline (T0), immediately after the 8-week intervention (T1), and 2-month follow-up (T2).
Change in self-esteem measured by the Rosenberg Self-Esteem Scale (RSES)
Self-esteem was assessed using the 10-item Rosenberg Self-Esteem Scale (RSES). Total scores range from 10 to 40, with higher scores indicating higher self-esteem. Changes in total RSES scores were evaluated between the intervention and routine-care control groups.
Measured: Baseline (T0), immediately after the 8-week intervention (T1), and 2-month follow-up (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start15 Jan 2026
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced MenopauseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the nurse-led self-compassion intervention group or the routine-care control group. Outcomes were assessed at baseline, immediately after the eight-week intervention, and at two-month follow-up.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aya Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Ibrahim, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884357
- Sponsor's protocol ID
- ERCNMA 1000/4/1/190/26
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nurse-Led Self-Compassion Intervention on Self-Compassion, Menopausal Symptom Severity, and Self-Esteem Among Women With Induced Menopause
- ClinicalTrials.gov ID
- NCT07884357
- Acronym / sponsor ID
- ERCNMA 1000/4/1/190/26
- Conditions
- Induced Menopause
- Keywords
- Self-Compassion, Menopausal Symptoms, Self-Esteem, Nurse-Led Intervention, Mindfulness, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aya IbrahimUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 20 Oct 2026 (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.
This study evaluated the effectiveness of a nurse-led self-compassion intervention on self-compassion, menopausal symptom severity, and self-esteem among women with medically induced menopause. A parallel-group randomized controlled trial was conducted among 150 women recruited from the outpatient clinics of the Cancer Institute, Menoufia University, Egypt. Participants were randomly assigned to an intervention group (75 women) or a routine-care control group (75 women). The intervention consisted of eight weekly group sessions lasting 45-60 minutes each. Outcomes were assessed before the intervention, immediately after the eight-week intervention, and at two-month follow-up using the Self-Compassion Scale, Rosenberg Self-Esteem Scale, and Menopause Rating Scale.
Detailed description
Study Design and Setting
A parallel-group randomized controlled trial with repeated assessments was conducted in the outpatient clinics of the Cancer Institute, Menoufia University, Egypt. The study included 150 women with medically induced menopause who met the eligibility criteria.
Participants and Allocation
Eligible women were recruited using purposive sampling. After eligibility assessment and written informed consent, participants were randomly allocated in a 1:1 ratio to the nurse-led self-compassion intervention group (n = 75) or the routine-care control group (n = 75). The allocation sequence was computer-generated and concealed using sequentially numbered, opaque, sealed envelopes.
Intervention
The intervention was delivered by the nurse researcher over eight consecutive weeks. Participants in the intervention group were divided into six subgroups of 12-13 women. Each subgroup attended one group session per week, with each session lasting approximately 45-60 minutes. Sessions incorporated psychoeducation, mindfulness training, emotional regulation strategies, self-kindness practices, self-esteem enhancement, and coping strategies for menopause-related challenges. Activities included reflective exercises, journaling, self-compassion letter writing, breathing exercises, body-awareness activities, and group discussions. The control group received routine care.
Outcome Assessment
Outcomes were assessed at three time points: baseline before the intervention (T0), immediately after completion of the eight-week intervention (T1), and two months after completion of the intervention (T2). The Self-Compassion Scale was used to assess self-compassion, the Rosenberg Self-Esteem Scale to assess self-esteem, and the Menopause Rating Scale to assess menopausal symptom severity.
Ethical Considerations
The study was conducted in accordance with the Declaration of Helsinki. Ethical approval was obtained from the Ethical and Research Committee of the Faculty of Nursing, Menoufia University (Approval No. ERCNMA 1000/4/1/190/26). Official authorization was obtained from the hospital director before commencement of the study. All participants provided written informed consent. Participation was voluntary, and participants were informed of their right to withdraw at any time without consequence. Participant anonymity and confidentiality were maintained through coded identifiers, and study data were securely stored with access restricted to authorized researchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the nurse-led self-compassion intervention group or the routine-care control group. Outcomes were assessed at baseline, immediately after the eight-week intervention, and at two-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Self-Compassion Intervention Group | Experimental | Behavioral: Nurse-Led Self-Compassion InterventionParticipants in this group received an eight-week nurse-led self-compassion intervention consisting of one group session per week, with each session lasting 45-60 minutes. The sessions incorporated psychoeducation, mindfulness training, emotional regulation strategies, self-kindness practices, self-esteem enhancement, and coping strategies for menopause-related challenges. Activities included journaling, self-compassion letter writing, breathing exercises, body-awareness activities, and group discussions. |
| Routine-Care Control Group | No intervention | –Participants in this group received routine care without the structured nurse-led self-compassion intervention. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 35-55 years.
- Women with medically induced menopause.
- Women experiencing menopausal symptoms.
- Women able to understand and communicate effectively.
- Women willing to participate in the study.
Key exclusion criteria (3 listed)
- Women with a severe psychiatric disorder or cognitive impairment that could interfere with participation.
- Women currently receiving psychological or psychiatric treatment for a mental health disorder.
- Women with a medical or psychological condition that could interfere with participation in the intervention or assessment of study outcomes.
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 |
|---|---|---|
| Nurse-Led Self-Compassion InterventionAn eight-week nurse-led self-compassion intervention delivered through weekly group sessions lasting 45-60 minutes each. The sessions incorporated psychoeducation, mindfulness training, emotional regulation strategies, self-kindness practices, self-esteem enhancement, and coping strategies for menopause-related challenges. | Behavioural | Nurse-Led Self-Compassion Intervention Group |
Primary outcome
Change in menopausal symptom severity measured by the Menopause Rating Scale (MRS)
Time frame: Baseline (T0), immediately after the 8-week intervention (T1), and 2-month follow-up (T2).
Menopausal symptom severity was assessed using the Menopause Rating Scale (MRS), an 11-item scale covering somato-vegetative, psychological, and urogenital symptoms. The total score ranges from 0 to 44, with higher scores indicating greater symptom severity. Changes in total MRS scores were evaluated between the intervention and routine-care control groups across the three assessment time points.
2 secondary outcomes
Change in self-compassion measured by the Self-Compassion Scale (SCS)
Time frame: Baseline (T0), immediately after the 8-week intervention (T1), and 2-month follow-up (T2).
Change in self-esteem measured by the Rosenberg Self-Esteem Scale (RSES)
Time frame: Baseline (T0), immediately after the 8-week intervention (T1), and 2-month follow-up (T2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Self-Compassion Intervention in people with Induced Menopause, run by Aya Ibrahim 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 20 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in menopausal symptom severity measured by the Menopause Rating Scale (MRS) (time frame: Baseline (T0), immediately after the 8-week intervention (T1), and 2-month follow-up (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.