Symptom Monitoring and Menopausal Symptoms

What this trial studies

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.

Conditions in scope

• Menopause

Interventions

• Symptom Monitoring (Behavioral) — Reporting symptoms each day via a symptom questionnaire

Who can join

Women only · Ages 18 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Women
• Aged 18+
• Reporting at least 2 menopausal hot flushes per day
• Self-reported peri- or post-menopausal status.

Exclusion criteria

• Male
• Under age 18
• Reported fewer than 2 hot flushes per day
• Does not self-report peri- or post-menopausal status.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2021-03-14
• Primary completion: 2021-10-14
• Last update posted: 2025-03-25
• First posted: 2022-11-02

Sponsor & contact

Lead sponsor: University of South Wales (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Menopausal symptom changes via the Daily Record Keeping (DRK) form (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 (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.

Related ClearedRx care

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