Symptom Monitoring and Menopausal Symptoms

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05603234
• Other study ID #: 21059
• Status: Completed
• Phase: N/A
• Start date: March 14, 2021
• Est. completion date: October 14, 2021

Study information

• Verified date: October 2022
• Source: University of South Wales
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

Behavioral:
• Symptom Monitoring
Reporting symptoms each day via a symptom questionnaire

Locations

Country	Name	City	State
United Kingdom	University of South Wales	Treforest	Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of South Wales

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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