Symptom Management Program Based on Story Theory for Postmenopausal Women (SEMSTOP)
SEMSTOP
The Effect of Symptom Management Program Based on Story Theory on Vasomotor Symptoms and Sleep Quality in Postmenopausal Women
1 other identifier
interventional
76
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
November 30, 2022
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedFebruary 15, 2023
February 1, 2023
28 days
November 30, 2022
February 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Pittsburgh Sleep Quality Index
It will be used to measure sleep qualıty of postmenoposal women
1st months
Menopause Symptoms Rating Scale
It will be used to evaluate menopaus symptoms of postmenoposal women
1st months
Secondary Outcomes (2)
The Pittsburgh Sleep Quality Index
3rd months
Menopause Symptoms Rating Scale:
3rd months
Study Arms (2)
SEMSTOP
EXPERIMENTALIt is the group to which the initiatives will be applied.
Control
ACTIVE COMPARATORIt is the group to be compared to which the interventions will not be applied.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
November 30, 2022
First Posted
January 25, 2023
Study Start
February 1, 2023
Primary Completion
March 1, 2023
Study Completion
July 1, 2023
Last Updated
February 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share