Nursing CariesNCT05809960
The Effect of Nursing Support Program for Women in Surgical Menopause on Their Life Quality
A study testing Nursing support program and Routine nursing care in people with Nursing Caries and Surgical Menopause, run by Mehtap Gümüşay at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to determine the effect of the nursing support program developed in line with the Roy Adaptation Model on the quality of life, sleep quality and depressive symptom status of women in surgical menopause. Design: The study was a single-center, randomized, controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Surgical Menopause, Quality of Life
- What is being tested?
- Nursing support program and Routine nursing care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2020to 30 Jul 2021
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To have undergone surgical menopause
- To be literate
- To agree to participate in the study
Who cannot join
- To have natural menopause before the operation
- To have an oncological disease
- To have a psychiatric disease
- To use sleeping pills
- To use hormonal therapy
- To have physical and mental disability
- To have barrier to communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nursing Support Program Developed in Accordance With Roy Adaptation Model for Women in Surgical Menopause on Their Life Quality
Objective: The aim of this study was to determine the effect of the nursing support program developed in line with the Roy Adaptation Model on the quality of life, sleep quality and depressive symptom status of women in surgical menopause.
Design: The study was a single-center, randomized, controlled trial. Setting: This study was carried out in the gynecology clinic of a training and research hospital in Türkiye.
Read more
Method: The participants were randomized into two equal groups: intervention and control. The nursing support program developed in addition to routine nursing care was applied to the intervention group. Routine nursing care was given to the women in the control group. Data were collected with "Personal Information Form", "Menopause-Specific Quality of Life Questionnare", "Pittsburgh Sleep Quality Index" and "Perimenopausal Depression Scale".
Hypothesis:
H0-a: Nursing support program developed in line with the Roy Adaptation Model has no effect on the quality of life of women who have undergone surgical menopause.
H0-b: Nursing support program developed in line with the Roy Adaptation Model has no effect on the sleep quality of women who have undergone surgical menopause.
H0-c: Nursing support program developed in line with the Roy Adaptation Model has no effect on the depressive symptom status of women who have undergone surgical menopause.
- Conditions
- Nursing Caries, Surgical Menopause, Quality of Life
- Being tested
- Nursing support program, Routine nursing care
- Keywords
- Nursing support program, Roy Adaptation Model, Depressive symptom status, Sleep quality
- 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.
Nursing support programOther
It was discussed about the operation and surgical menopause that the woman will undergo after hospitalization for the operation. Education was given including the problems experienced during menopause and the approaches used to cope with them. Progressive relaxation exercises were taught and practiced. In order to carry out these procedures, an interview of approximately 45-60 minutes was held with each woman. During the program, four planned meetings were held. One of them was face-to-face and the others were phone calls. During the phone calls, the symptoms experienced by the women and their coping methods were discussed and the questions of the women were answered. The average of each phone call was 20-30 minutes.
Routine nursing careOther
Routine nursing care was given to the control group. The clinical routine has not been exceeded. It includes discharge training for the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Investigation Group | Experimental | Education was given, which was prepared in line with the Roy Adaptation Theory and considering the literature, including the problems experienced in menopausal periods and the approaches used to cope with them. The progressive relaxation exercise was explained and taught to the women and the first application was provided with the instructions. "Menopause and Life" booklet prepared in line with Roy Adaptation Theory was given to support the education given and to remember the information afterwards. Receives: Other: Nursing support program |
| Control Group | Active comparator | Routine nursing care was given to the control group. The clinical routine has not been exceeded. Receives: Other: Routine nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life quality
Women's quality of life was evaluated with the Menopause-Specific Quality of Life Questionnaire. The questionnaire consists of 4 sub-dimensions. The score for each dimension is calculated separately. High scores from the questionnaire indicate low quality of life.
Measured: 6 months
Sleep quality
Sleep quality of women was evaluated with the Pittsburgh Sleep Quality Index. The index consists of 7 sub-dimensions. The score for each dimension is calculated separately.
Measured: 6 months
Depressive symptom status
Depressive symptom status of women was evaluated with the Perimenopausal Depression Scale. The scale consists of 5 subscales. Minimum point is "0" an maximum point is "48".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start20 Jan 2020
- Primary completion18 Feb 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies 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
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehtap Gümüşay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehtap Gümüşay, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809960
- Sponsor's protocol ID
- OrduU-SBF-MG-1
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 12 Apr 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Support Program Developed in Accordance With Roy Adaptation Model for Women in Surgical Menopause on Their Life Quality
- ClinicalTrials.gov ID
- NCT05809960
- Acronym / sponsor ID
- OrduU-SBF-MG-1
- Conditions
- Nursing Caries, Surgical Menopause, Quality of Life
- Keywords
- Nursing support program, Roy Adaptation Model, Depressive symptom status, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Mehtap GümüşayUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 12 Apr 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.
Objective: The aim of this study was to determine the effect of the nursing support program developed in line with the Roy Adaptation Model on the quality of life, sleep quality and depressive symptom status of women in surgical menopause.
Design: The study was a single-center, randomized, controlled trial. Setting: This study was carried out in the gynecology clinic of a training and research hospital in Türkiye.
Method: The participants were randomized into two equal groups: intervention and control. The nursing support program developed in addition to routine nursing care was applied to the intervention group. Routine nursing care was given to the women in the control group. Data were collected with "Personal Information Form", "Menopause-Specific Quality of Life Questionnare", "Pittsburgh Sleep Quality Index" and "Perimenopausal Depression Scale".
Hypothesis:
H0-a: Nursing support program developed in line with the Roy Adaptation Model has no effect on the quality of life of women who have undergone surgical menopause.
H0-b: Nursing support program developed in line with the Roy Adaptation Model has no effect on the sleep quality of women who have undergone surgical menopause.
H0-c: Nursing support program developed in line with the Roy Adaptation Model has no effect on the depressive symptom status of women who have undergone surgical menopause.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigation Group | Experimental | Other: Nursing support programEducation was given, which was prepared in line with the Roy Adaptation Theory and considering the literature, including the problems experienced in menopausal periods and the approaches used to cope with them. The progressive relaxation exercise was explained and taught to the women and the first application was provided with the instructions. "Menopause and Life" booklet prepared in line with Roy Adaptation Theory was given to support the education given and to remember the information afterwards. |
| Control Group | Active comparator | Other: Routine nursing careRoutine nursing care was given to the control group. The clinical routine has not been exceeded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To have undergone surgical menopause
- To be literate
- To agree to participate in the study
Key exclusion criteria (7 listed)
- To have natural menopause before the operation
- To have an oncological disease
- To have a psychiatric disease
- To use sleeping pills
- To use hormonal therapy
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 |
|---|---|---|
| Nursing support programIt was discussed about the operation and surgical menopause that the woman will undergo after hospitalization for the operation. Education was given including the problems experienced during menopause and the approaches used to cope with them. Progressive relaxation exercises were taught and practiced. In order to carry out these procedures, an interview of approximately 45-60 minutes was held with each woman. During the program, four planned meetings were held. One of them was face-to-face and the others were phone calls. During the phone calls, the symptoms experienced by the women and their coping methods were discussed and the questions of the women were answered. The average of each phone call was 20-30 minutes. | Other | Investigation Group |
| Routine nursing careRoutine nursing care was given to the control group. The clinical routine has not been exceeded. It includes discharge training for the surgery. | Other | Control Group |
Primary outcome
Life quality
Time frame: 6 months
Women's quality of life was evaluated with the Menopause-Specific Quality of Life Questionnaire. The questionnaire consists of 4 sub-dimensions. The score for each dimension is calculated separately. High scores from the questionnaire indicate low quality of life.
Sleep quality
Time frame: 6 months
Sleep quality of women was evaluated with the Pittsburgh Sleep Quality Index. The index consists of 7 sub-dimensions. The score for each dimension is calculated separately.
Depressive symptom status
Time frame: 6 months
Depressive symptom status of women was evaluated with the Perimenopausal Depression Scale. The scale consists of 5 subscales. Minimum point is "0" an maximum point is "48".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing support program and Routine nursing care in people with Nursing Caries and Surgical Menopause, run by Mehtap Gümüşay at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life quality (time frame: 6 months). The study lists 3 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 12 Apr 2023.