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Completed

NCT Number: NCT05603234

Symptom Monitoring and Menopausal Symptoms

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.

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Key information

Conditions

Menopause Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Wales

Treforest, Wales, CF371DL, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symptom Monitoring

Behavioral

Reporting symptoms each day via a symptom questionnaire

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Help seeking intentions

    Time frame: at baseline and after 2 weeks of symptom monitoring

    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.

  2. General Self Efficacy

    Time frame: at baseline and after 2 weeks of symptom monitoring

    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.

  3. Decision making efficacy

    Time frame: at baseline after 2 weeks of symptom monitoring

    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.

  4. Health communication

    Time frame: at baseline after 2 weeks of symptom monitoring

    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.

  5. Health Anxiety

    Time frame: at baseline and after 2 weeks of symptom monitoring

    Changes in Health Anxiety scores as assessed via the Health Orientation Scale (HOS). Reductions in Health Anxiety after 2-weeks would suggest beneficial effects.

  6. Health Consciousness

    Time frame: at baseline and after 2 weeks of symptom monitoring

    Changes in Health Consciousness scores as assessed via the HOS. Reductions in Health Consciousness scores after 2-weeks would suggest beneficial effects.

  7. Coping preference

    Time frame: Measured at baseline to assess whether coping preference moderated symptom monitoring outcomes

    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).

  8. Trait neuroticism

    Time frame: Measured at baseline to assess whether trait neuroticism moderated symptom monitoring outcomes

    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).

Sponsors and collaborators

Lead sponsor

University of South Wales

Other

Registry information

Official study title

Evaluating the Effects of Symptom Monitoring on Physical & Emotional Outcomes During Menopause: A Pilot Randomised Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2022
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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