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

Menopause Clinical Trial

Official title:

Reducing Menopausal Symptoms for Women During Menopause Using Group Education in a Primary Health Care Setting: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852811
• Other study ID #: fou2016
• Secondary ID: registration num
• Status: Completed
• Phase: N/A
• First received: May 26, 2016
• Last updated: August 1, 2016
• Start date: October 2009
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 2015
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause

Intervention

Other:
• Group education
Intervention involving two education session with topics common in menopause transition.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in menopause symptoms during baseline to four month follow up. The measurement that be used were The Menopause Rating Scale (MRS).	Primary outcome measure: Change in menopausal symptoms (using the menopause rating scale).	from baseline to four month follow up	No
Primary	Change in depression symptoms during baseline to four month follow up. The measurement that be used was The Montgomery-Asberg Depression Rating Scale (MADRS).	Primary outcome measure: Change in depression score (using the Montgomery-Asberg depression rating scale)	from baseline to four month follow up	No