Effect of Viewing a Standardized Surgical Procedure Video on Preoperative Anxiety in Women Undergoing Benign Hysterectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in Beck Anxiety Inventory (BAI) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants received standard preoperative counseling plus a standardized surgical procedure video before hysterectomy.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Beck Anxiety Inventory (BAI) Score
时间窗: 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.
次要结局
未报告次要终点
研究者
Murat Cengiz
Gynecologic Oncology Fellow, Department of Obstetrics and Gynecology, Hacettepe University Faculty of Medicine
Hacettepe University