Clinical trial NCT05603234: Symptom Monitoring and Menopausal Symptoms
Official title: Evaluating the Effects of Symptom Monitoring on Physical & Emotional Outcomes During Menopause: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Menopause
Hot flushes
Women's Health
Symptom Monitoring
Lead sponsor: University of South Wales
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Menopausal symptom changes via the Daily Record Keeping (DRK) form
timeFrame: at baseline and after 2 weeks of symptom monitoring
measure: Emotional outcomes via the Daily Record Keeping (DRK) form
timeFrame: at baseline and after 2 weeks of symptom monitoring
Secondary outcomes:
measure: Help seeking intentions
timeFrame: at baseline and after 2 weeks of symptom monitoring
measure: General Self Efficacy
timeFrame: at baseline and after 2 weeks of symptom monitoring
measure: Decision making efficacy
timeFrame: at baseline after 2 weeks of symptom monitoring
measure: Health communication
timeFrame: at baseline after 2 weeks of symptom monitoring
measure: Health Anxiety
timeFrame: at baseline and after 2 weeks of symptom monitoring
measure: Health Consciousness
timeFrame: at baseline and after 2 weeks of symptom monitoring
measure: Coping preference
timeFrame: Measured at baseline to assess whether coping preference moderated symptom monitoring outcomes
measure: Trait neuroticism
timeFrame: Measured at baseline to assess whether trait neuroticism moderated symptom monitoring outcomes
Other outcomes:
Locations:
city: Treforest
country: United Kingdom
facility: University of South Wales
state: Wales
Study officials:
References:
citation: 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.