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Symptom Management Program Based on Story Theory for Postmenopausal Women (SEMSTOP)

NCT05697133 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-02-15

No results posted yet for this study

Summary

Purpose: To investigate the effect of the Symptom Management Program Based on Story Theory on vasomotor symptoms and sleep quality in postmenopausal women.

Design: The type of this research is mixed method (qualitative and quantitative research design together). It enables to strengthen the weaknesses of mixed method research, to increase the generalizability of the results, and to produce more reliable outputs regarding theory and practice. The quantitative research dimension is a randomized single-blind pretest-posttest experimental model with a control group. The qualitative research dimension is the descriptive phenomenological design.

Method: The research will be carried out at Ömürevleri, Atakum, Mimar Sinan, Çobanlı and Yenimahalle Family Health Centers located in different regions of the Atakum District of Samsun. After informing the women who come to the Family Health Centers about the face-to-face research, the research will be conducted completely online (due to the COVID-19 pandemic) after the verbal consent of the women who volunteered to participate in the research and their contact numbers are obtained. The postmenopausal women who apply to the institutions where the research will be conducted and meet the inclusion criteria constitute the population of the research. When the sample size calculated with the G.Power program was taken as Pittsburgh Sleep Quality Index score mean and standard deviation value as 6.57±1.23, with 5% significance level, 80% test power, 0.700 effect size, there were at least 68 groups, 34 for the experimental group and 34 for the control group. identified as a person. Considering the sample loss in the experimental and control groups, with 10% more sampling, a total of 76 women will be included in the sample, with 38 women in each group. n the study, the data will be collected with the Personal Information Form, the Menopause Symptoms Assessment Scale, the Pittsburgh Sleep Quality Index and the Story Theory Based Semi-Structured Interview Form (for qualitative research) developed by the researchers in line with the literature. As a result of the study, the data will be evaluated separately as qualitative and quantitative.

Conditions

Interventions

OTHER

SEMSTOP

This program has been developed based on Story Theory and will be implemented individually online. The session content, units and topics in the program are arranged according to the conceptual content and flow of the theory. The program has been created in a certain flow, based on the concepts of purposeful dialogue, connecting with itself and facilitating the theory.

OTHER

control

control grup

Sponsors & Collaborators

  • Ondokuz Mayıs University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2023-03-31
Completion
2023-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05697133 on ClinicalTrials.gov