MenopauseSEMSTOPNCT05697133
Symptom Management Program Based on Story Theory for Postmenopausal Women (SEMSTOP)
A study testing SEMSTOP in people with Menopause, run by Ondokuz Mayıs University.
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). Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- SEMSTOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Menopause
- Being tested
- SEMSTOP, control
- Keywords
- Sleep Quality, Postmenopause
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEMSTOPOther
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.
controlOther
control grup
| Study group | Role | What they receive |
|---|---|---|
| SEMSTOP | Experimental | It is the group to which the initiatives will be applied. Receives: Other: SEMSTOP |
| Control | Active comparator | It is the group to be compared to which the interventions will not be applied. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pittsburgh Sleep Quality Index
It will be used to measure sleep qualıty of postmenoposal women
Measured: 1st months
Menopause Symptoms Rating Scale
It will be used to evaluate menopaus symptoms of postmenoposal women
Measured: 1st months
Secondary outcomes (2)
The Pittsburgh Sleep Quality Index
It will be used to measure sleep quality of postmenoposal women
Measured: 3rd months
Menopause Symptoms Rating Scale:
It will be used to evaluate menopaus symptoms of postmenoposal women
Measured: 3rd months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Guven, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697133
- Sponsor's protocol ID
- 21063324
- Acronym
- SEMSTOP
- Status last verified
- Feb 2023
- First submitted
- 30 Nov 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Symptom Management Program Based on Story Theory on Vasomotor Symptoms and Sleep Quality in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05697133
- Acronym / sponsor ID
- SEMSTOP / 21063324
- Conditions
- Menopause
- Keywords
- Sleep Quality, Postmenopause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEMSTOP | Experimental | Other: SEMSTOPIt is the group to which the initiatives will be applied. |
| Control | Active comparator | Other: controlIt is the group to be compared to which the interventions will not be applied. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Having a communication barrier
- Having problems with internet access
- Being in the premenopausal period
- Undergoing surgical menopause
- Getting a diagnosis of respiratory system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEMSTOPThis 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. | Other | SEMSTOP |
| controlcontrol grup | Other | Control |
Primary outcome
The Pittsburgh Sleep Quality Index
Time frame: 1st months
It will be used to measure sleep qualıty of postmenoposal women
Menopause Symptoms Rating Scale
Time frame: 1st months
It will be used to evaluate menopaus symptoms of postmenoposal women
2 secondary outcomes
The Pittsburgh Sleep Quality Index
Time frame: 3rd months
Menopause Symptoms Rating Scale:
Time frame: 3rd months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing SEMSTOP in people with Menopause, run by Ondokuz Mayıs University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emel GÜVEN (05414607732, emel.guven@omu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pittsburgh Sleep Quality Index (time frame: 1st months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.