Symptom Monitoring and Menopausal Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Behavioral: Symptom Monitoring

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wales
    • Treforest, Wales, United Kingdom, CF371DL
      • University of South Wales

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Symptom Monitoring Intervention; This group reported their symptoms every day for 14 days.	Behavioral: Symptom Monitoring; Reporting symptoms each day via a symptom questionnaire
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at baseline and after 2 weeks of symptom monitoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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 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 at baseline to assess whether trait neuroticism moderated symptom monitoring outcomes

Collaborators and Investigators

• Sponsor: University of South Wales

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2021
• Primary Completion (Actual): October 14, 2021
• Study Completion (Actual): October 14, 2021

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Menopause; Women's Health; Hot flushes; Symptom Monitoring
• Other Study ID Numbers: 21059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No