MenopauseNCT05603234
Symptom Monitoring and Menopausal Symptoms
A study testing Symptom Monitoring in people with Menopause, run by University of South Wales at 1 site in United Kingdom.
Trial summary
A recent systematic review suggested that symptom monitoring can result in reductions in menopausal symptoms and improvements in health-related behaviours. To date, no studies have experimentally investigated whether symptom monitoring could be beneficial as an intervention for menopausal women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Symptom Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2021to 14 Oct 2021
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- Aged 18+
- Reporting at least 2 menopausal hot flushes per day
- Self-reported peri- or post-menopausal status.
Who cannot join
- Male
- Under age 18
- Reported fewer than 2 hot flushes per day
- Does not self-report peri- or post-menopausal status.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of South Wales
Treforest, Wales, CF371DL
About this study
Official title: Evaluating the Effects of Symptom Monitoring on Physical & Emotional Outcomes During Menopause: A Pilot Randomised Controlled Trial
A recent systematic review suggested that symptom monitoring can result in reductions in menopausal symptoms and improvements in health-related behaviours. To date, no studies have experimentally investigated whether symptom monitoring could be beneficial as an intervention for menopausal women.
One hundred menopausal women were randomised into either a Monitoring-intervention or Control group. A mixed between/ within design was employed, with group membership (i.e., Monitoring-intervention or Control) as the between-subjects component, and time (i.e., baseline and 2-weeks follow-up) as the within-subjects component. Dependent variables included symptom reductions and emotional reactions. Secondary outcomes included help-seeking, communication, medical decision-making, health awareness, self-efficacy, and health anxiety.
- Conditions
- Menopause
- Being tested
- Symptom Monitoring
- Keywords
- Menopause, Hot flushes, Women's Health, Symptom Monitoring
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom MonitoringBehavioural
Reporting symptoms each day via a symptom questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Symptom Monitoring Intervention | Experimental | This group reported their symptoms every day for 14 days. Receives: Behavioral: Symptom Monitoring |
| Control | No intervention | This group did not monitor their symptoms every day for the 14 day period, however they did report their symptoms at the beginning and end of the 14 day period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopausal symptom changes via the Daily Record Keeping (DRK) form
Changes in menopausal symptom scores after 2-weeks of symptom monitoring, where reductions in symptoms would suggest a beneficial outcomes.
Measured: at baseline and after 2 weeks of symptom monitoring
Emotional outcomes via the Daily Record Keeping (DRK) form
Changes in emotion scores after 2-weeks of symptom monitoring. The DRK assesses emotional outcomes via specific emotion subscales including Negative Emotions, Positive affect, Anxiety, Depression, Loneliness. Reductions in Negative Emotions, Anxiety, Loneliness, Depression after 2-weeks would suggest benefical effects, as would increases in Positive Affect.
Measured: at baseline and after 2 weeks of symptom monitoring
Secondary outcomes (8)
Help seeking intentions
Changes in Help Seeking Intention scores as assessed via the General Help Seeking Questionnaire (GHSQ). Increases in GHSQ scores at 2-weeks would indicate benefical effects on help seeking behaviour.
Measured: at baseline and after 2 weeks of symptom monitoring
General Self Efficacy
Changes in General Self Efficacy scores as assessed via the General Self Efficacy (GSE) scale. Increases in GSE scores at 2-weeks would indicate beneficial effects on self efficacy.
Measured: at baseline and after 2 weeks of symptom monitoring
Decision making efficacy
Changes in Decision making efficacy scores as assessed via the Decision Self Efficacy (DSE) scale. Increases in DSE scores after 2-weeks would suggest benefical effects on medical decision making.
Measured: at baseline after 2 weeks of symptom monitoring
Health communication
Changes in Health communication scores as assessed via the Willingness to Communicate about Health (WTCH) questionnaire. Increases in WTCH scores after 2-weeks would suggest benefical effects on health communication.
Measured: at baseline after 2 weeks of symptom monitoring
Health Anxiety
Changes in Health Anxiety scores as assessed via the Health Orientation Scale (HOS). Reductions in Health Anxiety after 2-weeks would suggest beneficial effects.
Measured: at baseline and after 2 weeks of symptom monitoring
Health Consciousness
Changes in Health Consciousness scores as assessed via the HOS. Reductions in Health Consciousness scores after 2-weeks would suggest beneficial effects.
Measured: at baseline and after 2 weeks of symptom monitoring
Coping preference
Monitoring/ Blunting Coping preference assessed via the Miller's Behavioural Style Scale (MBSS). The MBSS score can be used in analyses as a continuous variable, with individuals displaying more or less monitoring coping characteristics. Scores range from 0 (no monitoring characteristics) to 72 (high monitoring characteristics).
Measured: Measured at baseline to assess whether coping preference moderated symptom monitoring outcomes
Trait neuroticism
Trait neuroticism was assessed via the IPIP-NEO 10-item neuroticism subscale. This scale ranges from 10 (low trait neuroticism) to 50 (high trait neuroticism).
Measured: Measured at baseline to assess whether trait neuroticism moderated symptom monitoring outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start14 Mar 2021
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
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.
- 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
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603234
- Sponsor's protocol ID
- 21059
- Status last verified
- Mar 2025
- First submitted
- 10 Oct 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrews R, Hale G, John B, Lancastle D. Evaluating the Effects of Symptom Monitoring on Menopausal Health Outcomes: A Systematic Review and Meta-Analysis. Front Glob Womens Health. 2021 Dec 3;2:757706. doi: 10.3389/fgwh.2021.757706. eCollection 2021.
PubMed 34927137
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Symptom Monitoring on Physical & Emotional Outcomes During Menopause: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05603234
- Acronym / sponsor ID
- 21059
- Conditions
- Menopause
- Keywords
- Menopause, Hot flushes, Women's Health, Symptom Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of South WalesUniversity, hospital or other
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 2 Nov 2022 (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.
A recent systematic review suggested that symptom monitoring can result in reductions in menopausal symptoms and improvements in health-related behaviours. To date, no studies have experimentally investigated whether symptom monitoring could be beneficial as an intervention for menopausal women.
One hundred menopausal women were randomised into either a Monitoring-intervention or Control group. A mixed between/ within design was employed, with group membership (i.e., Monitoring-intervention or Control) as the between-subjects component, and time (i.e., baseline and 2-weeks follow-up) as the within-subjects component. Dependent variables included symptom reductions and emotional reactions. Secondary outcomes included help-seeking, communication, medical decision-making, health awareness, self-efficacy, and health anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom Monitoring Intervention | Experimental | Behavioral: Symptom MonitoringThis group reported their symptoms every day for 14 days. |
| Control | No intervention | –This group did not monitor their symptoms every day for the 14 day period, however they did report their symptoms at the beginning and end of the 14 day period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- Aged 18+
- Reporting at least 2 menopausal hot flushes per day
- Self-reported peri- or post-menopausal status.
Key exclusion criteria (4 listed)
- Male
- Under age 18
- Reported fewer than 2 hot flushes per day
- Does not self-report peri- or post-menopausal status.
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 |
|---|---|---|
| Symptom MonitoringReporting symptoms each day via a symptom questionnaire | Behavioural | Symptom Monitoring Intervention |
Primary outcome
Menopausal symptom changes via the Daily Record Keeping (DRK) form
Time frame: at baseline and after 2 weeks of symptom monitoring
Changes in menopausal symptom scores after 2-weeks of symptom monitoring, where reductions in symptoms would suggest a beneficial outcomes.
Emotional outcomes via the Daily Record Keeping (DRK) form
Time frame: at baseline and after 2 weeks of symptom monitoring
Changes in emotion scores after 2-weeks of symptom monitoring. The DRK assesses emotional outcomes via specific emotion subscales including Negative Emotions, Positive affect, Anxiety, Depression, Loneliness. Reductions in Negative Emotions, Anxiety, Loneliness, Depression after 2-weeks would suggest benefical effects, as would increases in Positive Affect.
8 secondary outcomes
Help seeking intentions
Time frame: at baseline and after 2 weeks of symptom monitoring
General Self Efficacy
Time frame: at baseline and after 2 weeks of symptom monitoring
Decision making efficacy
Time frame: at baseline after 2 weeks of symptom monitoring
Health communication
Time frame: at baseline after 2 weeks of symptom monitoring
Health Anxiety
Time frame: at baseline and after 2 weeks of symptom monitoring
Health Consciousness
Time frame: at baseline and after 2 weeks of symptom monitoring
Coping preference
Time frame: Measured at baseline to assess whether coping preference moderated symptom monitoring outcomes
Trait neuroticism
Time frame: Measured at baseline to assess whether trait neuroticism moderated symptom monitoring outcomes
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 25 Mar 2025.
- Background: PubMed 34927137Andrews R, Hale G, John B, Lancastle D. Evaluating the Effects of Symptom Monitoring on Menopausal Health Outcomes: A Systematic Review and Meta-Analysis. Front Glob Womens Health. 2021 Dec 3;2:757706. doi: 10.3389/fgwh.2021.757706. eCollection 2021.
- 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 Symptom Monitoring in people with Menopause, run by University of South Wales at 1 site in United Kingdom.
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 4 inclusion and 4 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 25 Mar 2025. 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 United Kingdom. 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?
Menopausal symptom changes via the Daily Record Keeping (DRK) form (time frame: at baseline and after 2 weeks of symptom monitoring). The study lists 2 primary outcomes in all. 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 NCT05603234, 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 25 Mar 2025.