Preoperative Anxiety Experienced by the PatientSHARENCT07741019
Effect of Viewing a Standardized Surgical Procedure Video on Preoperative Anxiety in Women Undergoing Benign Hysterectomy
A study testing Viewing a Surgical Procedure Video and Standard Preoperative Counseling in people with Preoperative Anxiety Experienced by the Patient, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Preoperative anxiety is common among women undergoing hysterectomy and may adversely affect perioperative outcomes and patient experience. This randomized controlled trial evaluates whether viewing a standardized surgical procedure video before surgery reduces preoperative anxiety compared with standard preoperative… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Preoperative Anxiety Experienced by the Patient
- What is being tested?
- Viewing a Surgical Procedure Video and Standard Preoperative Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 15 Jun 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older.
- Scheduled to undergo elective hysterectomy for benign gynecologic conditions.
- Able to understand the study procedures and provide written informed consent.
- Able to complete the Beck Anxiety Inventory (BAI) questionnaire.
Who cannot join
- Planned hysterectomy for suspected or confirmed gynecologic malignancy.
- Emergency surgery.
- Current use of psychiatric medications.
- Visual or hearing impairment that could interfere with viewing the surgical -video or completing the study procedures.
- Inability to read or understand Turkish.
- Cognitive impairment or any condition preventing completion of the study questionnaires or provision of informed consent.
- Previous participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Viewing a Standardized Surgical Procedure Video on Preoperative Anxiety in Women Undergoing Benign Hysterectomy: A Randomized Controlled Trial
Preoperative anxiety is common among women undergoing hysterectomy and may adversely affect perioperative outcomes and patient experience. This randomized controlled trial evaluates whether viewing a standardized surgical procedure video before surgery reduces preoperative anxiety compared with standard preoperative counseling alone. Women scheduled for hysterectomy for benign gynecologic conditions were randomized to receive either standard counseling plus a standardized surgical video or standard counseling alone. The primary outcome is the change in Beck Anxiety Inventory (BAI) score before surgery. Secondary outcomes include health-related quality of life measured by the Short Form-12 (SF-12) questionnaire one month after surgery and exploratory analyses of inflammatory biomarkers associated with anxiety.
Read the detailed description
Women scheduled to undergo hysterectomy for benign gynecologic indications at Hacettepe University were enrolled in this single-center randomized controlled trial. Eligible participants were randomly assigned in a 1:1 ratio to receive either standard preoperative counseling supplemented by a standardized surgical procedure video (intervention group) or standard preoperative counseling alone (control group). Beck Anxiety Inventory (BAI) scores were assessed immediately before randomization and again immediately before surgery to evaluate changes in preoperative anxiety. Health-related quality of life was assessed one month after surgery using the Short Form-12 (SF-12) questionnaire. Exploratory analyses evaluated the association between baseline anxiety and systemic inflammatory biomarkers, including the systemic immune-inflammation index (SII) and systemic inflammatory response index (SIRI). The study aimed to determine whether standardized surgical video education improves perioperative psychological outcomes without adversely affecting postoperative quality of life.
- Being tested
- Viewing a Surgical Procedure Video, Standard Preoperative Counseling
- Keywords
- Preoperative Anxiety, Hysterectomy, Surgical Video Education, Randomized Controlled Trial, Beck Anxiety Inventory, Health-Related Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viewing a Surgical Procedure VideoBehavioural
Participants viewed a publicly available video of a benign hysterectomy procedure before surgery in addition to standard preoperative counseling.
Standard Preoperative CounselingBehavioural
Participants received standard preoperative counseling before surgery without viewing the surgical procedure video.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Surgical Video | Experimental | Participants viewed a standardized video of the surgical procedure in addition to standard preoperative counseling. Receives: Behavioral: Viewing a Surgical Procedure Video |
| Standard Preoperative Counseling | Active comparator | Participants received standard preoperative counseling without viewing the surgical procedure video. Receives: Behavioral: Standard Preoperative Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Anxiety Inventory (BAI) Score
The primary outcome is the change in Beck Anxiety Inventory (BAI) score from before the intervention to the preoperative assessment immediately before surgery. The change will be compared between the intervention and control groups.
Measured: From baseline (before intervention) to immediately before surgery (same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Apr 2025
- Primary completion15 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Anxiety Experienced by the PatientStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Cengiz, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741019
- Sponsor's protocol ID
- HU-GYNONC-2025/22-01
- Acronym
- SHARE
- Status last verified
- Apr 2025
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Viewing a Standardized Surgical Procedure Video on Preoperative Anxiety in Women Undergoing Benign Hysterectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07741019
- Acronym / sponsor ID
- SHARE / HU-GYNONC-2025/22-01
- Keywords
- Preoperative Anxiety, Hysterectomy, Surgical Video Education, Randomized Controlled Trial, Beck Anxiety Inventory, Health-Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 3 Aug 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.
Preoperative anxiety is common among women undergoing hysterectomy and may adversely affect perioperative outcomes and patient experience. This randomized controlled trial evaluates whether viewing a standardized surgical procedure video before surgery reduces preoperative anxiety compared with standard preoperative counseling alone. Women scheduled for hysterectomy for benign gynecologic conditions were randomized to receive either standard counseling plus a standardized surgical video or standard counseling alone. The primary outcome is the change in Beck Anxiety Inventory (BAI) score before surgery. Secondary outcomes include health-related quality of life measured by the Short Form-12 (SF-12) questionnaire one month after surgery and exploratory analyses of inflammatory biomarkers associated with anxiety.
Detailed description
Women scheduled to undergo hysterectomy for benign gynecologic indications at Hacettepe University were enrolled in this single-center randomized controlled trial. Eligible participants were randomly assigned in a 1:1 ratio to receive either standard preoperative counseling supplemented by a standardized surgical procedure video (intervention group) or standard preoperative counseling alone (control group). Beck Anxiety Inventory (BAI) scores were assessed immediately before randomization and again immediately before surgery to evaluate changes in preoperative anxiety. Health-related quality of life was assessed one month after surgery using the Short Form-12 (SF-12) questionnaire. Exploratory analyses evaluated the association between baseline anxiety and systemic inflammatory biomarkers, including the systemic immune-inflammation index (SII) and systemic inflammatory response index (SIRI). The study aimed to determine whether standardized surgical video education improves perioperative psychological outcomes without adversely affecting postoperative quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Surgical Video | Experimental | Behavioral: Viewing a Surgical Procedure VideoParticipants viewed a standardized video of the surgical procedure in addition to standard preoperative counseling. |
| Standard Preoperative Counseling | Active comparator | Behavioral: Standard Preoperative CounselingParticipants received standard preoperative counseling without viewing the surgical procedure video. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients aged 18 years or older.
- Scheduled to undergo elective hysterectomy for benign gynecologic conditions.
- Able to understand the study procedures and provide written informed consent.
- Able to complete the Beck Anxiety Inventory (BAI) questionnaire.
Key exclusion criteria (7 listed)
- Planned hysterectomy for suspected or confirmed gynecologic malignancy.
- Emergency surgery.
- Current use of psychiatric medications.
- Visual or hearing impairment that could interfere with viewing the surgical -video or completing the study procedures.
- Inability to read or understand Turkish.
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 |
|---|---|---|
| Viewing a Surgical Procedure VideoParticipants viewed a publicly available video of a benign hysterectomy procedure before surgery in addition to standard preoperative counseling. | Behavioural | Standardized Surgical Video |
| Standard Preoperative CounselingParticipants received standard preoperative counseling before surgery without viewing the surgical procedure video. | Behavioural | Standard Preoperative Counseling |
Primary outcome
Change in Beck Anxiety Inventory (BAI) Score
Time frame: From baseline (before intervention) to immediately before surgery (same day)
The primary outcome is the change in Beck Anxiety Inventory (BAI) score from before the intervention to the preoperative assessment immediately before surgery. The change will be compared between the intervention and control groups.
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 3 Aug 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.
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 Viewing a Surgical Procedure Video and Standard Preoperative Counseling in people with Preoperative Anxiety Experienced by the Patient, run by Hacettepe 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 4 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 3 Aug 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?
Change in Beck Anxiety Inventory (BAI) Score (time frame: From baseline (before intervention) to immediately before surgery (same day)). 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 3 Aug 2026.