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

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ClinicalTrials.gov Identifier: NCT02852811
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Menopause Other: Group education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Menopausal Symptoms for Women During Menopause Using Group Education in a Primary Health Care Setting: A Randomized Controlled Trial
Study Start Date : October 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
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.
Other: Group education
Intervention involving two education session with topics common in menopause transition.

No Intervention: 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.



Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852811


Sponsors and Collaborators
Vastra Gotaland Region
Investigators
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Principal Investigator: Gun Rembeck, PhD Research and Development Center Södra Älvsborg, Närhälsan, Research and Development, Primary Health Care Region, Västra Götaland, Sweden,
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02852811    
Other Study ID Numbers: fou2016
registration number: 041-09 ( Registry Identifier: The Regional Ethical Review Board )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vastra Gotaland Region:
Climacteric
Education
Mental health
Menopause