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OpenTrials
Completed

NCT Number: NCT07741019

Effect of Viewing a Standardized Surgical Procedure Video on Preoperative Anxiety in Women Undergoing Benign Hysterectomy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University

Ankara, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Viewing a Surgical Procedure Video

Behavioral

Participants viewed a publicly available video of a benign hysterectomy procedure before surgery in addition to standard preoperative counseling.

Standard Preoperative Counseling

Behavioral

Participants received standard preoperative counseling before surgery without viewing the surgical procedure video.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Effect of Viewing a Standardized Surgical Procedure Video on Preoperative Anxiety in Women Undergoing Benign Hysterectomy: A Randomized Controlled Trial

Acronym: SHARE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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