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

Menopause Clinical Trial

— SEMSTOP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05697133
• Other study ID #: 21063324
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: July 2023

Study information

• Verified date: February 2023
• Source: Ondokuz Mayis University
• Contact: Emel GÜVEN
• Phone: 05414607732
• Email: emel.guven[@]omu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: July 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause

Intervention

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.
• control
control grup

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Pittsburgh Sleep Quality Index	It will be used to measure sleep quality of postmenoposal women	1st months
Primary	Menopause Symptoms Rating Scale	It will be used to evaluate menopaus symptoms of postmenoposal women	1st months
Secondary	The Pittsburgh Sleep Quality Index	It will be used to measure sleep quality of postmenoposal women	3rd months
Secondary	Menopause Symptoms Rating Scale:	It will be used to evaluate menopaus symptoms of postmenoposal women	3rd months