NCT05603234

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

October 10, 2022

Last Update Submit

March 24, 2025

Conditions

Menopause

Keywords

MenopauseHot flushesWomen's HealthSymptom Monitoring

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Help seeking intentions

    at baseline and after 2 weeks of symptom monitoring

  • General Self Efficacy

    at baseline and after 2 weeks of symptom monitoring

  • Decision making efficacy

    at baseline after 2 weeks of symptom monitoring

  • Health communication

    at baseline after 2 weeks of symptom monitoring

  • Health Anxiety

    at baseline and after 2 weeks of symptom monitoring

  • +3 more secondary outcomes

Study Arms (2)

Symptom Monitoring Intervention

EXPERIMENTAL

This group reported their symptoms every day for 14 days.

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

Interventions

Symptom MonitoringBEHAVIORAL

Reporting symptoms each day via a symptom questionnaire

Symptom Monitoring Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be women experiencing self-reported menopause/ perimenopause
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Wales

Treforest, Wales, CF371DL, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34927137BACKGROUND

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

November 2, 2022

Study Start

March 14, 2021

Primary Completion

October 14, 2021

Study Completion

October 14, 2021

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)