Comparative Efficacy of Acupressure Versus Acupressure Combined with Audiovisual Distraction for Anxiety Reduction in Children During Inferior Alveolar Nerve Block (IANB): A Single-Blinded Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in dental anxiety scores measured using the Modified Child Dental Anxiety Scale (MCDAS) from baseline to post-procedure, compared across the three groups.
研究概览
简要总结
This single blinded randomized controlled trial aims to evaluate and compare the effectiveness of auricular acupressure alone and auricular acupressure combined with audiovisual distraction ie AVD or VR in reducing dental anxiety, physiological stress, and pain perception in children undergoing inferior alveolar nerve block.
A total of 90 healthy children aged 6 to12 years requiring IANB will be randomly allocated into three equal groups. Group 1 Control with no intervention. Group 2 Auricular acupressure at Shenmen, Shen points etc, applied bilaterally 2 minutes before and during IANB. Group 3 Same acupressure plus AVD using age appropriate animated videos or VR.
Primary outcome is Change in MCDAS anxiety scores from baseline to post procedure.
Secondary outcomes is Pulse rate, SpO2, Wong Baker FACES pain score, and FLACC behavioural pain score.
Data will be statistically analysed using the Kruskal Wallis test for between group comparisons and Friedman test for within group comparisons across time intervals, with significance set at p than 0.05.
This study is expected to clarify whether combining acupressure with AVD provides a synergistic benefit in reducing dental anxiety and improving behaviour during IANB in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 6 to 12 years requiring IANB for routine dental treatment.
- •ASA I or II (healthy or mild systemic illness).
- •Willing to undergo acupressure with or without AVD or VR.
排除标准
- •Ear infections, skin lesions, or allergy to adhesive materials.
- •Epilepsy, motion sickness, cognitive or communication disorders, or visual/hearing impairments preventing participation.
- •Use of anxiolytics, sedatives, or analgesics within 24 to 48 hrs.
- •Allergy to local anaesthetics or study materials.
- •Acute systemic illness or contraindication for IANB.
结局指标
主要结局
Change in dental anxiety scores measured using the Modified Child Dental Anxiety Scale (MCDAS) from baseline to post-procedure, compared across the three groups.
时间窗: Dental anxiety (MCDAS) | 1. Baseline (T0): Before intervention (while seated, prior to IANB). | 2. Post-procedure (T3): After completion of IANB injection.
次要结局
- Score on Wong Baker FACES Pain Rating Scale, FLACC scale immediately after IANB.(At baseline, during injection & post injection)
研究者
Geetanjali Mahajan
Saveetha Dental College and Hospitals, Saveetha University, Chennai