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
|Condition or disease||Intervention/treatment||Phase|
|Menopause||Other: Group education||Not Applicable|
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.
Grouping:The women will be randomly allocated to intervention group and control group (60/60).
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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)
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
|Principal Investigator:||Gun Rembeck, PhD||Research and Development Center Södra Älvsborg, Närhälsan, Research and Development, Primary Health Care Region, Västra Götaland, Sweden,|