Comparative Evaluation of Effect of Distraction Techniques using Virtual Reality, Binaural Beats and Cartoon Assisted Visual/Audio Analgesia Methods on Pain Perception and Anxiety Levels in 6 –10-year-old Children
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparison Among Techniques:
研究概览
简要总结
Title: Comparative Evaluation of the Effect of Distraction Techniques Using Virtual Reality, Binaural Beats, and Cartoon-Assisted Visual/Audio Analgesia on Pain Perception and Anxiety Levels in 6–10-Year-Old Children
Objective: To evaluate and compare the effectiveness of Virtual Reality (VR), Binaural Beats, and Cartoon-Assisted Visual/Audio Analgesia in reducing pain perception and anxiety during administration of local anesthesia in children aged 6–10 years.
Study Design: Randomized Clinical Trial
Setting: Postgraduate Clinical Section, Department of Paediatric and Preventive Dentistry
Participants: 80 children (aged 6–10 years), undergoing their first dental visit, with positive Frankl behavior rating.
Sampling Technique: Stratified random sampling with lottery method for group allocation.
Intervention Groups:
- Group A (VR): Immersive VR video/audio during procedure
- Group B (Binaural Beats): Headphones with binaural beats and visual display
- Group C (Cartoon): Favorite cartoon on tablet with headphones
- Group D (Control): Standard care without distraction
Outcomes Measured:
- Pain Perception: Wong-Baker FACES Scale (child) and FLACC Scale (observer)
- Anxiety Levels: Modified Yale Preoperative Anxiety Scale (m-YPAS)
- Biological Indicator: Pulse rate using pulse oximeter
Inclusion Criteria: Healthy, cooperative children aged 6–10 years undergoing routine dental procedures for the first time.
Exclusion Criteria: Children with developmental/sensory impairments, previous distraction use, or medications affecting behavior.
Data Analysis:
- Shapiro-Wilk test for normality
- One-Way ANOVA with Post Hoc Bonferroni for group comparisons
- Significance level: p < 0.05; Power: 80%; CI: 95%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 6–10 years, healthy, positive Frankl rating Undergoing routine dental procedures with consent or assent will be included Patient undergoing first dental visit.
排除标准
- •Medical or developmental conditions which prevent behavior guidance Sensory impairments Prior use of distraction methods Medication affecting anxiety/behavior.
结局指标
主要结局
Comparison Among Techniques:
时间窗: Objective for assessment of anxiety will be evaluated by pulse oximeter at T0 before treatment, T1 during treatment, and T2 after treatment. | Subjective assessment of anxiety will be evaluated by using Modified Yale Anxiety Scale at T0 before treatment and T1 during treatment. | Subjective assessment of pain will be evaluated by an observer during the procedure by FLACC Scale and after the procedure by the participants using Wong-Baker FACES scale.
VR may show the greatest reduction in both pain and anxiety due to its immersive nature. Binaural beats may help with anxiety reduction more than pain. Cartoon-assisted methods may be moderately effective in both dimensions.
时间窗: Objective for assessment of anxiety will be evaluated by pulse oximeter at T0 before treatment, T1 during treatment, and T2 after treatment. | Subjective assessment of anxiety will be evaluated by using Modified Yale Anxiety Scale at T0 before treatment and T1 during treatment. | Subjective assessment of pain will be evaluated by an observer during the procedure by FLACC Scale and after the procedure by the participants using Wong-Baker FACES scale.
Improved Child Cooperation:
时间窗: Objective for assessment of anxiety will be evaluated by pulse oximeter at T0 before treatment, T1 during treatment, and T2 after treatment. | Subjective assessment of anxiety will be evaluated by using Modified Yale Anxiety Scale at T0 before treatment and T1 during treatment. | Subjective assessment of pain will be evaluated by an observer during the procedure by FLACC Scale and after the procedure by the participants using Wong-Baker FACES scale.
Children exposed to these distraction techniques may demonstrate better behavioral compliance during dental treatment.
时间窗: Objective for assessment of anxiety will be evaluated by pulse oximeter at T0 before treatment, T1 during treatment, and T2 after treatment. | Subjective assessment of anxiety will be evaluated by using Modified Yale Anxiety Scale at T0 before treatment and T1 during treatment. | Subjective assessment of pain will be evaluated by an observer during the procedure by FLACC Scale and after the procedure by the participants using Wong-Baker FACES scale.
次要结局
未报告次要终点
研究者
Dr Vinaya Kumar Kulkarni
SMBT Dental College and Hospital, Sangamner