NCT06413875

Brief Summary

Objective: To determine the effect of menopausal symptom-specific education given to menopausal women via WhatsApp on their quality of life and genital self-image. Methods: The population of the study, which has a classical experimental design with a pretest-posttest control group, was comprised of women between the ages of 45-65 across Turkey. According to the power analysis performed in the G\*Power3.1 Program, the sample size was calculated as 64 participants for each group, with an effect size (0.418), 95% power and 0.05 type 1 error, and was completed with 158 women. Data were collected with the Introductory Information Form, the Menopause-Specific Quality of Life Scale (MSQLS) and the Female Genital Self-Image Scale (FGSIS). The research was conducted online via WhastApp in a pretest-educational intervention-posttest design. The data were analyzed in the SPSS 26.0 package program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

May 7, 2024

Last Update Submit

May 10, 2024

Conditions

Keywords

Genital imagemenopausewomansymptomquality of life

Outcome Measures

Primary Outcomes (2)

  • The total quality of life scale score of the intervention group that received training on menopause symptoms was better than the control group.

    Education Specific to Menopause Symptoms

    4 weeks

  • The genital self-image scale total score of the intervention group that received training on menopause symptoms was better than the control group.

    Education Specific to Menopause Symptoms

    4 weeks

Study Arms (2)

enterprise group

EXPERIMENTAL

The data collection form was sent online to the participants in the sample and they were asked to fill it out (pre-test). Two separate groups were opened on WhatsApp for the intervention and control groups. For this reason, in this study, the educational intervention included sending an informative video once a week and informative messages three days a week for four weeks.In the intervention part of the study, after all participants filled out the data collection form, the intervention group was informed about Menopause once a week on the first day of each week for four weeks. An information video prepared in line with the topics specified in the Symptom-Specific Training Booklet has been sent. Informative messages were sent via WhatsApp three days a week, in parallel with the training topic of each week (training intervention).After the training, a data collection form was sent to the intervention group via WhatsApp and the participants were asked to fill it out again (posttest).

Other: education

control group

NO INTERVENTION

The data collection form was sent online to the participants in the sample and they were asked to fill it out (pre-test). No educational intervention was given to the control group. After the training, a data collection form was sent to the control group via WhatsApp and the participants were asked to fill it out again (posttest).

Interventions

Education Specific to Menopause Symptoms

enterprise group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMenopausal women between the ages of 45-65
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between the ages of 45-65 between April and December 2023,
  • in the pre/peri/postmenopausal period,
  • not receiving hormone replacement therapy in the last 6 months,
  • not having had a gynecological operation,
  • women who have internet access, (6) use a smartphone,
  • voluntarily agree to participate in the study.

You may not qualify if:

  • Those who filled out the data collection form incompletely

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebru Cirban Ekrem

Bartın, 74100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were informed about the research, and then participants who agreed to participate in the research were given a number respectively. After the targeted sample number was reached, all participants were divided into intervention and control groups using a simple random numbers table.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The population of the study, which has a classical experimental design with a pretest-posttest control group, was comprised of women between the ages of 45-65 across Turkey. According to the power analysis performed in the G\*Power3.1 Program, the sample size was calculated as 64 participants for each group, with an effect size (0.418), 95% power and 0.05 type 1 error, and was completed with 158 women. Data were collected with the Introductory Information Form, the Menopause-Specific Quality of Life Scale (MSQLS) and the Female Genital Self-Image Scale (FGSIS). The research was conducted online via WhastApp in a pretest-educational intervention-posttest design. The data were analyzed in the SPSS 26.0 package program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 14, 2024

Study Start

April 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

The research is in the article writing phase. It will be published as an article.

Locations