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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptom Monitoring Intervention | Experimental | This group reported their symptoms every day for 14 days. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symptom Monitoring | Behavioral | Reporting symptoms each day via a symptom questionnaire |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
Participants must be women experiencing self-reported menopause/ perimenopause
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Wales | Treforest | Wales | CF371DL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34927137 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 14, 2021 | Oct 10, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |