HysterectomyNCT05063864
Post-Hysterectomy Nursing Support Program
A study testing Nursing Support Program in people with Hysterectomy, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study was conducted to evaluate the effectiveness of the nursing support program developed for women undergoing hysterectomy. Background: Hysterectomy is an important surgical intervention that affects women physically, sexually and psychosocially. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Nursing Support Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2017to 24 Jun 2019
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis benign hysterectomy and bilateral oophorectomy
- Having no communication problems.
Who cannot join
- Clinical diagnosis vaginal hysterectomy
- Clinical diagnosis psychiatric disorders and therefore used drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effectiveness of the Post-Hysterectomy Nursing Support Program: Randomized Controlled Study
Objective: This study was conducted to evaluate the effectiveness of the nursing support program developed for women undergoing hysterectomy.
Background: Hysterectomy is an important surgical intervention that affects women physically, sexually and psychosocially.
Method: The study is a single blind, randomized controlled study conducted at the Department of Obstetrics and Gynecology in a university hospital between November 2017 and November 2018. 60 women who had hysterectomy were divided into experimental and control groups and It was evaluated on the 1-2 day, 6-7 day and 2nd month. In the study, the nursing support program was applied only to women in the experimental group.
Read the detailed description
Aim: This study was conducted to evaluate the effectiveness of the nursing support program developed for women who had hysterectomy.
Methods: A prospective, randomised controlled study was conducted in the gynaecology clinic of a university hospital between November 2017 and November 2018. It was conducted in a single-blind, randomised controlled trial with a total of 60 women in the experimental and control groups. A nursing support program had been developed for women who have had a hysterectomy. The program developed for the experimental group and the routine program for routine maintenance and control group were applied. The initial evaluation was carried out postoperative on the 1st-2nd day, the second assessment was carried out on the 6th-7th day and the third evaluation was carried out at 2 months. The first interview was carried out in the hospital, and the second and third interviews were carried out with home visits. The sociodemographic data form, postoperative evaluation form, Female Sexual Function Index (FSFI), Epidemiological Studies and Central Depression Scale (EAMDS), Menopausal Symptoms Evaluation Scale (MSDS) and SF-12 quality of life scale were used to collect data.
- Conditions
- Hysterectomy
- Being tested
- Nursing Support Program
- Keywords
- hysterectomy, nursing support program,, menopausal symptoms, sexuality, depression, quality of life
- Medical subject headings
- Sexuality, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Support ProgramOther
Within the scope of the nursing support program, counselling services were provided to women by making regular phone calls that lasted 15-20 minutes once a week. Within the scope of the support program, two training booklets titled "Life After Hysterectomy Surgery" and "Women's Health During Menopause" were prepared by reviewing the literature.
| Study group | Role | What they receive |
|---|---|---|
| Nursing Support Program | Experimental | the group that applied the nursing support program Receives: Other: Nursing Support Program |
| No Nursing Support Program | No intervention | the group that did not receive a nursing support program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing Support Program
Change of postoperative symptoms in the postoperative data sheet at 2 months after hysterectomy, Change of sexual functions in female sexual function index (FSFI) 2 months after hysterectomy Change of mental status in epidemiological depression scale (CES-D) 2 months after hysterectomy Change in quality of life in SF-12 quality of life scale at 2 months after hysterectomy Change in menopausal symptoms in the menopausal symptoms rating scale (MRS) 2 months after hysterectomy
Measured: postoperative on the 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start20 Nov 2017
- Primary completion15 Nov 2018
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Yılmaz, Suleyman Demirel University
- Investigators
- Kübra Yilmaz, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063864
- Sponsor's protocol ID
- KYilmaz
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I am not sure.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effectiveness of the Post-Hysterectomy Nursing Support Program: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05063864
- Acronym / sponsor ID
- KYilmaz
- Conditions
- Hysterectomy
- Keywords
- hysterectomy, nursing support program,, menopausal symptoms, sexuality, depression, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 1 Oct 2021 (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: This study was conducted to evaluate the effectiveness of the nursing support program developed for women undergoing hysterectomy.
Background: Hysterectomy is an important surgical intervention that affects women physically, sexually and psychosocially.
Method: The study is a single blind, randomized controlled study conducted at the Department of Obstetrics and Gynecology in a university hospital between November 2017 and November 2018. 60 women who had hysterectomy were divided into experimental and control groups and It was evaluated on the 1-2 day, 6-7 day and 2nd month. In the study, the nursing support program was applied only to women in the experimental group.
Detailed description
Aim: This study was conducted to evaluate the effectiveness of the nursing support program developed for women who had hysterectomy.
Methods: A prospective, randomised controlled study was conducted in the gynaecology clinic of a university hospital between November 2017 and November 2018. It was conducted in a single-blind, randomised controlled trial with a total of 60 women in the experimental and control groups. A nursing support program had been developed for women who have had a hysterectomy. The program developed for the experimental group and the routine program for routine maintenance and control group were applied. The initial evaluation was carried out postoperative on the 1st-2nd day, the second assessment was carried out on the 6th-7th day and the third evaluation was carried out at 2 months. The first interview was carried out in the hospital, and the second and third interviews were carried out with home visits. The sociodemographic data form, postoperative evaluation form, Female Sexual Function Index (FSFI), Epidemiological Studies and Central Depression Scale (EAMDS), Menopausal Symptoms Evaluation Scale (MSDS) and SF-12 quality of life scale were used to collect data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nursing Support Program | Experimental | Other: Nursing Support Programthe group that applied the nursing support program |
| No Nursing Support Program | No intervention | –the group that did not receive a nursing support program |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis benign hysterectomy and bilateral oophorectomy
- Having no communication problems.
Key exclusion criteria (2 listed)
- Clinical diagnosis vaginal hysterectomy
- Clinical diagnosis psychiatric disorders and therefore used drugs
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 ProgramWithin the scope of the nursing support program, counselling services were provided to women by making regular phone calls that lasted 15-20 minutes once a week. Within the scope of the support program, two training booklets titled "Life After Hysterectomy Surgery" and "Women's Health During Menopause" were prepared by reviewing the literature. | Other | Nursing Support Program |
Primary outcome
Nursing Support Program
Time frame: postoperative on the 2 months.
Change of postoperative symptoms in the postoperative data sheet at 2 months after hysterectomy, Change of sexual functions in female sexual function index (FSFI) 2 months after hysterectomy Change of mental status in epidemiological depression scale (CES-D) 2 months after hysterectomy Change in quality of life in SF-12 quality of life scale at 2 months after hysterectomy Change in menopausal symptoms in the menopausal symptoms rating scale (MRS) 2 months after hysterectomy
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 1 Oct 2021.
- Individual participant dataSharing planned: No. I am not sure.
Related trials for Hysterectomy
Not yet recruiting
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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.
Kübra Yilmaz principal investigator
Suleyman Demirel University
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 in people with Hysterectomy, run by Suleyman Demirel University 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 2 inclusion and 2 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 1 Oct 2021. 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?
Nursing Support Program (time frame: postoperative on the 2 months.). 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 1 Oct 2021.