- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07739381
Effects of Virtual Reality and Tablet Distraction During IV Cannulation in Children
The Effect of Watching an Entertaining Video With Virtual Reality Glasses and a Tablet on Pain, Anxiety, and Fear During Intravenous Cannulation in Children in the Emergency Department: A Randomized Controlled Trial
연구 개요
상세 설명
The study was designed as a randomized controlled trial involving children aged 7 to 12 years who required intravenous cannulation in a pediatric emergency department. Eligible participants were randomly assigned in a 1:1:1 ratio to a virtual reality group, a tablet group, or a control group.
Children assigned to the virtual reality group watched an entertaining audiovisual video using a virtual reality headset during intravenous cannulation. Children assigned to the tablet group watched the same video on a tablet during the procedure. Children in the control group underwent intravenous cannulation according to the routine clinical practice of the emergency department without an audiovisual distraction intervention.
Anxiety and fear were assessed immediately before intravenous cannulation and again five minutes after the procedure. Pain was assessed immediately after intravenous cannulation. The primary purpose of the study was to determine whether virtual reality and tablet-based distraction reduced procedure-related pain, anxiety, and fear and to compare the effectiveness of these interventions.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Kütahya
-
Kütahya, Kütahya, 터키 (Türkiye), 4300
- Kütahya Evliya Çelebi Training and Research Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- It was that the child belonged to the 7-12 age group and was fully conscious.
Exclusion Criteria:
- Children with hearing, cognitive, or visual impairments; children unaccompanied by a parent; children with whom communication cannot be established; and children with critical health issues and/or conditions requiring immediate intervention.
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 |
|---|---|
|
실험적: Virtual Reality Group
Children watched an age-appropriate entertaining video using a virtual reality headset during intravenous cannulation.
|
Children in the virtual reality group received virtual reality-based distraction during intravenous cannulation.
A virtual reality headset was used to divert the child's attention from the procedure.
|
|
실험적: tablet Group
Children watched the same age-appropriate entertaining video on a tablet during intravenous cannulation.
|
Children in the tablet group watched an age-appropriate cartoon on a tablet during intravenous cannulation to divert their attention from the procedure.
|
|
간섭 없음: control group
Children underwent intravenous cannulation according to routine clinical practice without any audiovisual distraction intervention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain During Intravenous Cannulation
기간: Immediately after intravenous cannulation
|
Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale.
The scale consists of six facial expressions representing increasing levels of pain.
Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Pain was assessed immediately after intravenous cannulation.
|
Immediately after intravenous cannulation
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Anxiety Before and After Intravenous Cannulation
기간: Immediately before and immediately after intravenous cannulation
|
Anxety was assesed using the scale .Higher scores indicate greater anxiety.
|
Immediately before and immediately after intravenous cannulation
|
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .