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

NCT02852811 | Completed

• 2 other identifiers: fou2016registration number: 041-09
• Study Type: interventional
• Target: 131
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menopause

Keywords

Climacteric; Education; Mental health; Menopause

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

group education

OTHER

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

control group

NO INTERVENTION

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.

Interventions

Group education OTHER

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

group education

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female gender, 45 to 55 years of age, comprehension and fluency in the Swedish language.

You may not qualify if:

• that the patient did not any longer want to participate in the study.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Gun Rembeck, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: August 2, 2016
• Study Start: October 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2015
• Last Updated: August 2, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share