Effectiveness of Weighted Blanket-Assisted Deep Pressure Stimulation in Reducing Anxiety and Pain During Local Anesthetic Injection for Pulpectomy in Children Aged 6–12 Years : A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The implementation of weighted blankets during pulpectomy procedures is anticipated to significantly attenuate pediatric dental anxiety, foster enhanced patient cooperation, and reduce the incidence of disruptive behaviors. Furthermore, by facilitating autonomic nervous system modulation, this non-pharmacological intervention may contribute to the physiological regulation of stress responses and diminish reliance on sedation or other pharmacological modalities.
研究概览
简要总结
Brief SummaryThis randomized controlled trial aims to evaluate the effectiveness of weighted blanket-assisted deep pressure stimulation in reducing anxiety and pain during local anesthetic injection for pulpectomy procedures in children aged 6–12 years. A total of 60 medically healthy, cooperative children will be randomly allocated into two groups: one receiving pulpectomy with a weighted blanket and the other without. Objective anxiety will be assessed using pulse oximeter-based heart rate monitoring, while subjective measures will include the Modified Venham Scale for anxiety and the Wong–Baker FACES Pain Scale for pain perception. The intervention involves placing a commercially available, appropriately sized weighted blanket (10–20% of body weight) over the child during treatment. The study hypothesizes that deep pressure stimulation through weighted blankets can serve as a safe, non-invasive method to reduce dental anxiety and pain, potentially minimizing the need for pharmacological behavior management strategies in pediatric dental care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Children aged between 6 and 12 years requiring pulpectomy procedure Medically healthy children Demonstrated cooperative or potentially cooperative behaviour using Frankl behaviour rating scale 3 or 4 No previous history of pulpectomy procedures Ability to understand and respond to pain assessment scales.
排除标准
- •Diagnosed sensory or neurodevelopmental disorders Eg. ASD, ADHD Known allergies to the materials used in weighted blankets Eg. cotton, PET pellets Presence of orthopaedic or musculoskeletal conditions that contraindicate use of weighted blankets.
结局指标
主要结局
The implementation of weighted blankets during pulpectomy procedures is anticipated to significantly attenuate pediatric dental anxiety, foster enhanced patient cooperation, and reduce the incidence of disruptive behaviors. Furthermore, by facilitating autonomic nervous system modulation, this non-pharmacological intervention may contribute to the physiological regulation of stress responses and diminish reliance on sedation or other pharmacological modalities.
时间窗: Objective assessment of anxiety will be evaluated by utilising a digital finger pulse oximeter at three different time intervals from T0 to T2 | T0 Before the treatment | T1 During the treatment | T2 After the treatment | Subjective assessment of anxiety will be evaluated by using modified Venham scale at two intervals | T0 Before the treatment | T1 After the treatment | Wong-Baker FACES Pain Scale will be used to evaluate the pain immediately after the administration of local anesthesia.
次要结局
未报告次要终点
研究者
Dr. Vinaya Kumar Kulkarni
SMBT Dental College and Hospital Sangamner