University
Ankara, 06230, Turkey (Türkiye)
NCT Number: NCT07741019
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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Notify Me18 year–70 year
Female
Interventional
Not applicable
Ankara, 06230, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants viewed a publicly available video of a benign hysterectomy procedure before surgery in addition to standard preoperative counseling.
Participants received standard preoperative counseling before surgery without viewing the surgical procedure video.
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.
Hacettepe University
Other
Effect of Viewing a Standardized Surgical Procedure Video on Preoperative Anxiety in Women Undergoing Benign Hysterectomy: A Randomized Controlled Trial
Acronym: SHARE
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