Symptom Monitoring and Menopausal Symptoms
- Conditions
- Menopause
- Registration Number
- NCT05603234
- Lead Sponsor
- University of South Wales
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 112
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Menopausal symptom changes via the Daily Record Keeping (DRK) form 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.
Emotional outcomes via the Daily Record Keeping (DRK) form 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 Outcome Measures
Name Time Method Health Anxiety 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.
General Self Efficacy 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.
Decision making efficacy 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.
Health Consciousness 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.
Coping preference 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).
Trait neuroticism 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).
Help seeking intentions 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.
Health communication 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.
Trial Locations
- Locations (1)
University of South Wales
🇬🇧Treforest, Wales, United Kingdom
University of South Wales🇬🇧Treforest, Wales, United Kingdom