The Effects of Menstrual Cycle Phase and Virtual Reality on Preoperative Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Amsterdam Preoperative Anxiety and Information Scale (APAIS) Score
研究概览
简要总结
This study aims to examine the effects of menstrual cycle phase and a virtual reality (VR) intervention on preoperative anxiety in female patients scheduled for septorhinoplasty surgery.
详细描述
This study was designed to evaluate the effects of menstrual cycle phases (follicular/luteal) and the use of virtual reality (VR) on preoperative anxiety levels and hemodynamic parameters in female patients scheduled for septorhinoplasty surgery. The study consisted of four groups: follicular phase with VR, follicular phase without VR, luteal phase with VR, and luteal phase without VR. All participants' preoperative anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI I-II) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). In the VR groups, heart rate and mean arterial pressure were recorded at baseline and at 5, 10, and 15 minutes during the video session. This study aims to determine whether VR, as a non-pharmacological method, is an effective tool for managing preoperative anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) I-II risk groups,
- •scheduled for elective septorhinoplasty,
- •either the follicular (days 1-12 from last menstruation) or luteal (days 20-24) phase of the menstrual cycle
排除标准
- •if they did not speak Turkish
- •in days 13-19 of their menstrual cycle,
- •menstrual irregularities,
- •undergone hysterectomy or bilateral salpingo-oophorectomy,
- •drug allergies,
- •psychiatric or cognitive dysfunction,
- •epilepsy,
- •claustrophobia,
- •alcohol-substance dependence,
- •blindness or deafness,
- •revision septorhinoplasty.
研究组 & 干预措施
Gorup 2: Luteal Phase + No VR
The 15-minute immersive virtual reality video, which offered both visual and auditory stimuli, was not shown.
In the preoperative period, heart rate and mean arterial pressure values were recorded at baseline, and at 5, 10, and 15 minutes over a 15-minute period. Participants were asked to complete the STAI I-II anxiety scales only once.
干预措施: State-Trait Anxiety Inventory (STAI I-II) (Other)
Gorup 2: Luteal Phase + No VR
The 15-minute immersive virtual reality video, which offered both visual and auditory stimuli, was not shown.
In the preoperative period, heart rate and mean arterial pressure values were recorded at baseline, and at 5, 10, and 15 minutes over a 15-minute period. Participants were asked to complete the STAI I-II anxiety scales only once.
干预措施: The decision for a 15-minute preoperative observation without visual and auditory experience depends on the phase of the menstrual cycle and group assignment. (Other)
Group 3: Follicular Phase + Virtual Reality (VR)
15-minute immersive virtual reality video providing both visual and auditory stimuli .Baseline and 5th, 10th, and 15th minute heart rate and mean arterial pressure values were recorded during the viewing of the video. After the video, the headset was removed, and the patients were asked to complete STAI I-II again.
干预措施: 15-minute video providing a visual and auditory experience (Training Video) (Other)
Group 3: Follicular Phase + Virtual Reality (VR)
15-minute immersive virtual reality video providing both visual and auditory stimuli .Baseline and 5th, 10th, and 15th minute heart rate and mean arterial pressure values were recorded during the viewing of the video. After the video, the headset was removed, and the patients were asked to complete STAI I-II again.
干预措施: State-Trait Anxiety Inventory (STAI I-II) (Other)
Group 4: Follicular Phase + No VR
The 15-minute immersive virtual reality video, which offered both visual and auditory stimuli, was not shown.
In the preoperative period, heart rate and mean arterial pressure values were recorded at baseline, and at 5, 10, and 15 minutes over a 15-minute period. Participants were asked to complete the STAI I-II anxiety scales only once.
干预措施: State-Trait Anxiety Inventory (STAI I-II) (Other)
Group 4: Follicular Phase + No VR
The 15-minute immersive virtual reality video, which offered both visual and auditory stimuli, was not shown.
In the preoperative period, heart rate and mean arterial pressure values were recorded at baseline, and at 5, 10, and 15 minutes over a 15-minute period. Participants were asked to complete the STAI I-II anxiety scales only once.
干预措施: The decision for a 15-minute preoperative observation without visual and auditory experience depends on the phase of the menstrual cycle and group assignment. (Other)
Group 1:Luteal Phase+ Virtual Reality (VR)
15-minute immersive virtual reality video providing both visual and auditory stimuli .Baseline and 5th, 10th, and 15th minute heart rate and mean arterial pressure values were recorded during the viewing of the video. After the video, the headset was removed, and the patients were asked to complete STAI I-II agai
干预措施: 15-minute video providing a visual and auditory experience (Training Video) (Other)
Group 1:Luteal Phase+ Virtual Reality (VR)
15-minute immersive virtual reality video providing both visual and auditory stimuli .Baseline and 5th, 10th, and 15th minute heart rate and mean arterial pressure values were recorded during the viewing of the video. After the video, the headset was removed, and the patients were asked to complete STAI I-II agai
干预措施: State-Trait Anxiety Inventory (STAI I-II) (Other)
结局指标
主要结局
Amsterdam Preoperative Anxiety and Information Scale (APAIS) Score
时间窗: Preoperative (before VR or baseline)
State-Trait Anxiety Inventory (STAI-I/II) Score
时间窗: Preoperative and Post-Intervention (after 15-minute video or control period)
次要结局
- Heart Rate(At baseline, and at 5, 10, and 15 minutes during video viewing)
研究者
Gamze Küçükosman
Principal Investigator, Department of Anesthesiology and Reanimation
Zonguldak Bulent Ecevit University