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OpenTrials
Completed

NCT Number: NCT02852811

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

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.

Completed

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Key information

Age range

45 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group education

Other

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

Primary outcomes

  1. Change in menopause symptoms during baseline to four month follow up. The measurement that be used were The Menopause Rating Scale (MRS).

    Time frame: from baseline to four month follow up

    Primary outcome measure: Change in menopausal symptoms (using the menopause rating scale).

  2. Change in depression symptoms during baseline to four month follow up. The measurement that be used was The Montgomery-Asberg Depression Rating Scale (MADRS).

    Time frame: from baseline to four month follow up

    Primary outcome measure: Change in depression score (using the Montgomery-Asberg depression rating scale)

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2015
First posted
Aug 2, 2016
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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