Evaluation of the Effects of Virtual Reality Application on Anxiety, Pain, and Physiological Stress Responses During Periodontal Frenectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain Intensity Assessed by Visual Analog Scale During and Immediately After Surgery
研究概览
简要总结
The goal of this clinical trial is to learn whether virtual reality can reduce anxiety, pain, and physiological stress responses during periodontal frenectomy in adults who need this surgical procedure.
The main questions it aims to answer are:
Does virtual reality reduce anxiety before and after periodontal frenectomy? Does virtual reality reduce pain during and after the procedure? Does virtual reality have a favorable effect on physiological stress responses such as blood pressure, heart rate, and oxygen saturation? Does virtual reality affect surgical process-related outcomes and early wound healing?
Researchers will compare adults who receive standard periodontal frenectomy with virtual reality-based audiovisual distraction to adults who receive standard periodontal frenectomy without virtual reality.
Participants will:
Complete anxiety and pain questionnaires before the procedure. Undergo periodontal frenectomy under local anesthesia. Be randomly assigned to either the virtual reality group or the control group. Have blood pressure, heart rate, oxygen saturation, and pain levels recorded at defined time points during the procedure.
Record daily pain levels and analgesic use for 7 days after surgery. Return for a 7-day follow-up visit for suture removal and early wound healing assessment.
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 (Outcomes Assessor)
盲法说明
Participants and the surgeon/care provider cannot be masked because of the nature of the virtual reality intervention. The 7-day early wound healing assessment will be performed by an outcomes assessor who is blinded to group assignment. The assessor will not be present during surgery, will not access the randomization result, and participants will be instructed not to disclose whether they received virtual reality. Postoperative questionnaires kept in sealed envelopes will be opened only after the blinded wound healing assessment is completed.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years
- •Classified as American Society of Anesthesiologists physical status I or II
- •Presence of a clinical indication for periodontal frenectomy
- •No previous periodontal surgery experience
- •No previous virtual reality experience
排除标准
- •Pregnancy or breastfeeding
- •Visual or hearing impairment that may prevent the use of the virtual reality headset
- •History of claustrophobia
- •History of vertigo
- •Use of analgesic or sedative medication within the last 24 hours
- •Current substance dependence
- •Presence of active infection in the surgical area
- •Current regular use of antidepressants, anxiolytics, antipsychotics, mood stabilizers, sedatives/hypnotics, or other psychotropic medications
研究组 & 干预措施
Virtual Reality Group
Participants in this group will receive standard periodontal frenectomy under local anesthesia with virtual reality-based audiovisual distraction during the procedure. After baseline assessments and randomization, a Meta Quest 3 head-mounted virtual reality device will be placed before local anesthesia. Participants will passively watch a standardized nature video with calming audio until the surgical procedure is completed.
干预措施: Virtual Reality-Based Audiovisual Distraction (Behavioral)
Virtual Reality Group
Participants in this group will receive standard periodontal frenectomy under local anesthesia with virtual reality-based audiovisual distraction during the procedure. After baseline assessments and randomization, a Meta Quest 3 head-mounted virtual reality device will be placed before local anesthesia. Participants will passively watch a standardized nature video with calming audio until the surgical procedure is completed.
干预措施: Standard Periodontal Frenectomy (Procedure)
Control Group
Participants in this group will receive standard periodontal frenectomy under local anesthesia without virtual reality or any other audiovisual distraction method. The surgical protocol, surgeon, local anesthesia protocol, and clinical environment will be the same as in the virtual reality group.
干预措施: Standard Periodontal Frenectomy (Procedure)
结局指标
主要结局
Pain Intensity Assessed by Visual Analog Scale During and Immediately After Surgery
时间窗: After local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery
Pain intensity will be assessed using a 0 to 10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain will be recorded after local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery.
State Anxiety Score Assessed by the State-Trait Anxiety Inventory-State Form
时间窗: Baseline before randomization and virtual reality application, and 10 minutes after completion of surgery
State anxiety will be assessed using the State-Trait Anxiety Inventory-State Form (STAI-S). The STAI-S consists of 20 items scored from 1 to 4, with a total score ranging from 20 to 80. Higher scores indicate higher state anxiety.
Blood Pressure During Periodontal Frenectomy
时间窗: Before virtual reality application, after local anesthesia, during the middle phase of surgery, and immediately after surgery
Systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) as physiological indicators of stress response.
Heart Rate During Periodontal Frenectomy
时间窗: Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
Heart rate will be measured as beats per minute using pulse oximetry. Heart rate will be used as a physiological indicator of stress response.
Peripheral Oxygen Saturation During Periodontal Frenectomy
时间窗: Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
Peripheral oxygen saturation will be measured as percentage using pulse oximetry. Peripheral oxygen saturation will be used as a physiological indicator of stress response.
次要结局
- Postoperative Pain Intensity Assessed by Visual Analog Scale(Postoperative days 1 to 7)
研究者
Muhammed Emin Kalender
Assistant Professor
Bilecik Seyh Edebali Universitesi