HysterectomyNCT07651449
The Effect of Hysterectomy Education and Counseling on Stress, Quality of Life, and Dyadic Adjustment
A study testing Postoperative Counseling in people with Hysterectomy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effects of postoperative education and counseling provided to women undergoing hysterectomy on dyadic adjustment, perceived stress, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Postoperative Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Mar 2026
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women undergoing hysterectomy Aged 18 years and older Married and living with their spouse Able to communicate in Turkish
Who cannot join
- Women with diagnosed psychiatric disorders Women with severe postoperative complications requiring intensive care
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu University, Graduate Education Institute, Department of Nursing
Gaziantep, Şahinbey/gaziantep, 27410
About this study
Official title: The Effect of Counseling and Education Given to Women Undergoing Hysterectomy on Dyadic Adjustment, Perceived Stress, and Quality of Life: A Randomized Controlled Trial
The aim of this study was to evaluate the effects of postoperative education and counseling provided to women undergoing hysterectomy on dyadic adjustment, perceived stress, and quality of life.
Read the detailed description
This randomized controlled trial was designed to evaluate the effects of postoperative education and counseling on perceived stress, quality of life, and dyadic adjustment among women undergoing hysterectomy. The study was conducted in the gynecology ward of Çukurova University Balcalı Hospital between September 2024 and February 2025. A total of 60 women were randomly assigned to either an intervention group (n=30) or a control group (n=30) using a simple randomization method. Data were collected using the Sociodemographic Data Questionnaire, the Perceived Stress Scale (PSS), the SF-12 Quality of Life Scale (SF-12 QoL), and the Revised Dyadic Adjustment Scale (RDAS). Women in the intervention group received structured hysterectomy education on the first postoperative day and weekly counseling sessions for four weeks after discharge. Women in the control group received routine postoperative care. Outcome assessments were performed at baseline and five weeks after enrollment.
- Conditions
- Hysterectomy
- Being tested
- Postoperative Counseling
- Keywords
- Hysterectomy, Perceived Stress, Quality of Life, Marital Adjustment, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative CounselingBehavioural
Participants received structured hysterectomy education on the first postoperative day and weekly counseling sessions for four weeks after discharge. Education and counseling focused on postoperative recovery, complication prevention, physical activity, sexual health, emotional support, healthy lifestyle behaviors, and adaptation following hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Hysterectomy Education and Counseling | Experimental | Women in this group received structured hysterectomy education on the first postoperative day and weekly counseling sessions for four weeks following discharge, in addition to routine postoperative care. Receives: Behavioral: Postoperative Counseling |
| control group | Experimental | Women in this group received routine postoperative care. No structured education or counseling was provided during the study period. Follow-up assessments were conducted five weeks after the pre-test, and an educational booklet was provided after completion of the post-test. Receives: Behavioral: Postoperative Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
Change in perceived stress levels measured using the Perceived Stress Scale.
Measured: Baseline and 5 weeks after intervention
SF-12 Quality of Life Scale
Change in physical and mental quality of life measured using the SF-12 Quality of Life Scale.
Measured: Baseline and 5 weeks after intervention
Revised Dyadic Adjustment Scale (RDAS)
Change in dyadic adjustment measured using the Revised Dyadic Adjustment Scale.
Measured: Baseline and 5 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Sep 2024
- Primary completion1 Feb 2025
- Study completion1 Mar 2026
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Keser, Hasan Kalyoncu University
- Investigators
- merve keser, Principal investigator, Hasan Kalyoncu University, Graduate Education Institute, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651449
- Sponsor's protocol ID
- 2024/98
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Counseling and Education Given to Women Undergoing Hysterectomy on Dyadic Adjustment, Perceived Stress, and Quality of Life: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07651449
- Acronym / sponsor ID
- 2024/98
- Conditions
- Hysterectomy
- Keywords
- Hysterectomy, Perceived Stress, Quality of Life, Marital Adjustment, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 16 Jun 2026 (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.
The aim of this study was to evaluate the effects of postoperative education and counseling provided to women undergoing hysterectomy on dyadic adjustment, perceived stress, and quality of life.
Detailed description
This randomized controlled trial was designed to evaluate the effects of postoperative education and counseling on perceived stress, quality of life, and dyadic adjustment among women undergoing hysterectomy. The study was conducted in the gynecology ward of Çukurova University Balcalı Hospital between September 2024 and February 2025. A total of 60 women were randomly assigned to either an intervention group (n=30) or a control group (n=30) using a simple randomization method. Data were collected using the Sociodemographic Data Questionnaire, the Perceived Stress Scale (PSS), the SF-12 Quality of Life Scale (SF-12 QoL), and the Revised Dyadic Adjustment Scale (RDAS). Women in the intervention group received structured hysterectomy education on the first postoperative day and weekly counseling sessions for four weeks after discharge. Women in the control group received routine postoperative care. Outcome assessments were performed at baseline and five weeks after enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysterectomy Education and Counseling | Experimental | Behavioral: Postoperative CounselingWomen in this group received structured hysterectomy education on the first postoperative day and weekly counseling sessions for four weeks following discharge, in addition to routine postoperative care. |
| control group | Experimental | Behavioral: Postoperative CounselingWomen in this group received routine postoperative care. No structured education or counseling was provided during the study period. Follow-up assessments were conducted five weeks after the pre-test, and an educational booklet was provided after completion of the post-test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing hysterectomy Aged 18 years and older Married and living with their spouse Able to communicate in Turkish
Key exclusion criteria (1 listed)
- Women with diagnosed psychiatric disorders Women with severe postoperative complications requiring intensive care
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 |
|---|---|---|
| Postoperative CounselingParticipants received structured hysterectomy education on the first postoperative day and weekly counseling sessions for four weeks after discharge. Education and counseling focused on postoperative recovery, complication prevention, physical activity, sexual health, emotional support, healthy lifestyle behaviors, and adaptation following hysterectomy. | Behavioural | Hysterectomy Education and Counseling, control group |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: Baseline and 5 weeks after intervention
Change in perceived stress levels measured using the Perceived Stress Scale.
SF-12 Quality of Life Scale
Time frame: Baseline and 5 weeks after intervention
Change in physical and mental quality of life measured using the SF-12 Quality of Life Scale.
Revised Dyadic Adjustment Scale (RDAS)
Time frame: Baseline and 5 weeks after intervention
Change in dyadic adjustment measured using the Revised Dyadic Adjustment Scale.
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 16 Jun 2026.
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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.
merve keser principal investigator
Hasan Kalyoncu University, Graduate Education Institute, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Counseling in people with Hysterectomy, run by Hasan Kalyoncu 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 1 inclusion and 1 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 16 Jun 2026. 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?
Perceived Stress Scale (PSS) (time frame: Baseline and 5 weeks after intervention). 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 16 Jun 2026.