Clinical trial NCT05697133: Symptom Management Program Based on Story Theory for Postmenopausal Women (SEMSTOP)
Official title: The Effect of Symptom Management Program Based on Story Theory on Vasomotor Symptoms and Sleep Quality in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Menopause
Keywords: Sleep Quality
Postmenopause
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 76
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Pittsburgh Sleep Quality Index
timeFrame: 1st months
measure: Menopause Symptoms Rating Scale
timeFrame: 1st months
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index
timeFrame: 3rd months
measure: Menopause Symptoms Rating Scale:
timeFrame: 3rd months
Other outcomes:
Locations:
Study officials:
References: