Reducing Menopausal Symptoms for Women During Menopause Using Group Education in a Primary Health Care Setting

Not Applicable

Completed

• Conditions: Menopause
• Interventions: Other: Group education

• Registration Number: NCT02852811
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

The aim of the study is to investigate if group education about the topic menopause to women in PHC can improve women's menopausal symptoms and reduce depression.

Detailed Description

One hundred twenty women will be included in the study. The survey population consists of Swedish-speaking women aged 45-55 years and seek care at Distriktsköterskemottagningen in Skene and at the Antenatal clinic in Svenljunga. The selection is done consecutively.

Method:

Grouping:The women will be randomly allocated to intervention group and control group (60/60).

The intervention:

The project includes the implementation of a total of four equivalent group treatments. Two of the group education will be at Skene Medical center and two Svenljunga Medical center. Group treatments are carried out by the district nurse and midwife in common. Each treatment group includes 15 women. A total of 60 women will thus participate in group education..Each treatment group consists of two information sessions of 2 hours.

The first information contains information about the menstrual cycle, hormonal shift, urogenital symptoms, and information on prevention and health promotion self-care.

The other information currently contains information about cardiovascular risk factors during menopause, relations, mental health, information about depressive symptoms and for preventive measures and health-promoting self-care.

The control group did not obtain any group education or any other intervention.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2011-06
• Study Completion: 2015-12
• Status Verified: 2016-05
• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-08-01
• Last Update Submitted: 2016-08-01
• Study First Posted: 2016-08-02
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

• female gender, 45 to 55 years of age, comprehension and fluency in the Swedish language.

Exclusion Criteria

• that the patient did not any longer want to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group education	Group education	To measure improvement of menopause symptoms and depression all participating women answered a baseline questionnaire and a follow-up questionnaire four month later. The questionnaires who were used: The Menopause Rating Scale (MRS) and The Montgomery-Asberg Depression Rating Scale (MADRS). MRS were used for reflecting menopause symptom and MADRS for depression symptoms.

Primary Outcome Measures

Name	Time	Method
Change in depression symptoms during baseline to four month follow up. The measurement that be used was The Montgomery-Asberg Depression Rating Scale (MADRS).	from baseline to four month follow up	Primary outcome measure: Change in depression score (using the Montgomery-Asberg depression rating scale)
Change in menopause symptoms during baseline to four month follow up. The measurement that be used were The Menopause Rating Scale (MRS).	from baseline to four month follow up	Primary outcome measure: Change in menopausal symptoms (using the menopause rating scale).