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

NCT ID: NCT02852811

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Group education

Intervention Type: OTHER

Intervention involving two education session with topics common in menopause transition.

control group

The control group did not obtain any group education or any other intervention. Women answered at baseline questionnaire and 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group education

Intervention involving two education session with topics common in menopause transition.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gun Rembeck, PhD

Role: PRINCIPAL_INVESTIGATOR

Research and Development Center Södra Älvsborg, Närhälsan, Research and Development, Primary Health Care Region, Västra Götaland, Sweden,

Other Identifiers

registration number: 041-09

Identifier Type: REGISTRY

Identifier Source: secondary_id

fou2016

Identifier Type: -

Identifier Source: org_study_id