Symptom Monitoring and Menopausal Symptoms

University of South Wales

Status: Completed

Conditions: Menopause

Treatments: Behavioral: Symptom Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05603234

21059

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

112 participants in 2 patient groups

Symptom Monitoring Intervention

Experimental group

Description:

This group reported their symptoms every day for 14 days.

Treatment:

Behavioral: Symptom Monitoring

Control

No Intervention group

Description:

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