- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07819123
Effects of Virtual Reality Content on Anxiety During Third Molar Surgery
A Comparative Evaluation of the Effects of Different Virtual Reality (VR) Content on Patient Anxiety During Impacted Mandibular Third Molar Surgery
This randomized controlled study evaluated whether the content of an immersive virtual reality environment influenced anxiety in adults undergoing surgical removal of an impacted mandibular third molar. A total of 75 patients aged 18-40 years with elevated dental anxiety were randomly assigned in a 1:1:1 ratio to a nature-based virtual reality group, an art-gallery virtual reality group, or a control group receiving conventional care without virtual reality.
Participants in the two virtual reality groups wore the same headset and headphones and viewed standardized 360-degree content from the beginning of surgery until completion of the procedure. Anxiety was assessed using the Modified Dental Anxiety Scale, the State-Trait Anxiety Inventory-State subscale, and an 11-point numerical anxiety rating scale. Systolic and diastolic blood pressure, heart rate, and peripheral oxygen saturation were also recorded. Measurements were obtained before local anesthesia, after local anesthesia but before surgery and virtual reality exposure, and immediately after wound closure, as applicable. The study compared changes in anxiety and physiological measures among the three groups and examined whether nature-based and art-gallery virtual reality content produced different responses.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rize Province
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Rize, Rize Province, 터키 (Türkiye), 53020
- Recep Tayyip Erdogan University Faculty of Dentistry
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age between 18 and 40 years
- American Society of Anesthesiologists (ASA) physical status I
- Presence of an impacted mandibular third molar for which surgical removal was indicated
- Pell and Gregory Class II, position B impaction
- Vertical or mesioangular impaction according to Winter's classification
- Preoperative Modified Dental Anxiety Scale (MDAS) score of 11 or higher
- Ability to understand the study procedures and complete the questionnaires
- Provision of written informed consent
Exclusion Criteria:
- A systemic or psychiatric condition considered likely to influence anxiety responses
- Regular use of medication that could alter anxiety or autonomic responses
- Use of antipsychotic or anxiolytic medication
- Smoking 10 or more cigarettes per day
- Previous surgical removal of an impacted tooth
- Acute infection in the operative region
- Pregnancy
- Severe visual or hearing impairment that could prevent adequate virtual reality exposure
- Inability to tolerate or correctly use the virtual reality headset
- Surgical duration exceeding 30 minutes
- Withdrawal of consent at any stage of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Nature-Based Virtual Reality
Participants viewed standardized investigator-developed nature-based 360-degree immersive content using a virtual reality headset and headphones from the beginning of surgery until completion of the procedure.
Exposure duration was determined by surgical duration and did not exceed 30 minutes.
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Participants viewed standardized investigator-developed nature-based 360-degree immersive content using a virtual reality headset and headphones.
The intervention began at the start of surgery and continued until completion of the procedure.
Exposure duration was determined by surgical duration and did not exceed 30 minutes.
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|
실험적: Art-Gallery Virtual Reality
Participants viewed standardized investigator-developed art-gallery 360-degree immersive content using the same virtual reality headset, headphones, audiovisual settings, and exposure period as the nature-based virtual reality group.
Exposure continued from the beginning of surgery until completion of the procedure and did not exceed 30 minutes.
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Participants viewed standardized investigator-developed art-gallery 360-degree immersive content using the same virtual reality headset, headphones, audiovisual settings, and exposure period as the nature-based virtual reality group.
The intervention began at the start of surgery and continued until completion of the procedure.
Exposure duration was determined by surgical duration and did not exceed 30 minutes.
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간섭 없음: Conventional Care Without Virtual Reality
Participants underwent the same standardized surgical procedure and received conventional clinical care without a virtual reality headset or an alternative audiovisual intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Modified Dental Anxiety Scale Score
기간: From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
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Dental anxiety was assessed using the five-item Modified Dental Anxiety Scale (MDAS).
Each item is scored from 1 to 5, producing a total score ranging from 5 to 25, with higher scores indicating greater dental anxiety.
The outcome was the change in total MDAS score from T0 to T2, calculated as the T2 score minus the T0 score.
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From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
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Change in State-Trait Anxiety Inventory-State Subscale Score
기간: From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
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State anxiety was assessed using the 20-item State-Trait Anxiety Inventory-State subscale (STAI-S).
Each item is scored from 1 to 4, producing a total score ranging from 20 to 80, with higher scores indicating greater state anxiety.
The outcome was the change in total STAI-S score from T0 to T2, calculated as the T2 score minus the T0 score.
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From before local anesthesia (T0) to immediately after wound closure and completion of the procedure (T2), during a single surgical visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Anxiety Visual Analog Scale Score
기간: At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
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Momentary anxiety was assessed using the study-designated Anxiety Visual Analog Scale (VAS-A), administered as an 11-point whole-number response scale ranging from 0 to 10.
A score of 0 indicated no anxiety, whereas a score of 10 indicated the highest perceived anxiety.
Changes in VAS-A scores across T0, T1, and T2 were compared among the study groups.
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At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
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Change in Systolic Blood Pressure
기간: At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
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Systolic blood pressure was measured in millimeters of mercury (mmHg) using the same automated monitoring device during a standardized five-minute assessment period at each time point.
Changes in systolic blood pressure across T0, T1, and T2 were compared among the study groups.
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At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
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Change in Diastolic Blood Pressure
기간: At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
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Diastolic blood pressure was measured in millimeters of mercury (mmHg) using the same automated monitoring device during a standardized five-minute assessment period at each time point.
Changes in diastolic blood pressure across T0, T1, and T2 were compared among the study groups.
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At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
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Change in Heart Rate
기간: At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
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Heart rate was measured in beats per minute (bpm) using the same automated monitoring device during a standardized five-minute assessment period at each time point.
Changes in heart rate across T0, T1, and T2 were compared among the study groups.
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At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
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Change in Peripheral Oxygen Saturation
기간: At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
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Peripheral oxygen saturation was measured as a percentage (SpO2) using the same monitoring device during a standardized five-minute assessment period at each time point.
Changes in peripheral oxygen saturation across T0, T1, and T2 were compared among the study groups.
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At three time points during a single surgical visit: before local anesthesia (T0), after local anesthesia but before surgery and virtual reality exposure (T1), and immediately after wound closure and completion of the procedure (T2)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2025/353
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
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