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

The Effect of Symptom Management Program Based on Story Theory on Vasomotor Symptoms and Sleep Quality in Postmenopausal Women

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05697133
Acronym
SEMSTOP
Enrollment
76
Registered
2023-01-25
Start date
2023-02-28
Completion date
2023-07-31
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

Sleep Quality, Postmenopause

Brief 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.

Interventions

OTHERSEMSTOP

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.

OTHERcontrol

control grup

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Be a volunteer, * To be literate to have a smart mobile phone/computer * To be in the first 2 years after menopause * Experiencing vasomotor symptoms

Exclusion criteria

* Having a communication barrier * Having problems with internet access * Being in the premenopausal period * Undergoing surgical menopause * Getting a diagnosis of respiratory system * Getting a diagnosis of hypertension and cardiovascular disease * Getting treatment for menopause, getting training on breathing exercises * Treatment for sleep disorders receive

Design outcomes

Primary

MeasureTime frameDescription
The Pittsburgh Sleep Quality Index1st monthsIt will be used to measure sleep qualıty of postmenoposal women
Menopause Symptoms Rating Scale1st monthsIt will be used to evaluate menopaus symptoms of postmenoposal women

Secondary

MeasureTime frameDescription
The Pittsburgh Sleep Quality Index3rd monthsIt will be used to measure sleep quality of postmenoposal women
Menopause Symptoms Rating Scale:3rd monthsIt will be used to evaluate menopaus symptoms of postmenoposal women

Contacts

Primary ContactEmel GÜVEN
emel.guven@omu.edu.tr05414607732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026