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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Menopause
• Intervention / Treatment: Other: SEMSTOP; Other: control

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEMSTOP; It is the group to which the initiatives will be applied.	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.
Active Comparator: Control; It is the group to be compared to which the interventions will not be applied.	Other: control; control grup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Pittsburgh Sleep Quality Index	It will be used to measure sleep quality of postmenoposal women	3rd months
Menopause Symptoms Rating Scale:	It will be used to evaluate menopaus symptoms of postmenoposal women	3rd months

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Sleep Quality; Postmenopause
• Other Study ID Numbers: 21063324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No