A randomized controlled trial to assess the effect of adding hypnoanaesthesia to existing standard infiltration anaesthetic technique in reducing pain and anxiety in children undergoing minor dermatosurgical procedures, as compared to standard infiltration anaesthetic technique alone
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the percentage difference in mean VAS (Visual Analogue Scale) score of perceived pain of local anaesthetic injection between children receiving additional hypnoanaesthesia in combination with standard infiltration anaesthetic technique versus those receiving standard infiltration anaesthetic technique alone during minor dermatosurgical procedures
研究概览
简要总结
Hypnotherapyor trance-induction is a well-documented technique of intentionally inducing analtered conscious state where increased acceptability of verbal suggestions hasbeen noted, along with a profound reduction of stress and anxiety. This can beused to alter perception of sensations including pain. This can be helpful forreduction of anxiety, as well as the perception of the needle prick, burningsensation of local anaesthetic agent, and residual sensations despite use oflocal anaesthetic agent. It has been used by small groups of surgeons, since1946, by itself and as an adjunct for a host of surgical procedures includingthose otherwise requiring general aanesthesia. Post-hypnotic suggestions can beused to have effects which continue after the trance and can be used to modifyperception of post-operative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Children 6 to 13 years of age undergoing minor procedures in the Dermatology Minor Operation theatre complex.
- •Can understand English or Hindi well
- •Can follow verbal suggestions for modulating breathing rate, contracting or relaxing muscles.
- •Patients agreeing to have their vitals monitored before, during and at end of procedure.
排除标准
- •Patients with an inability to follow verbal instructions.
结局指标
主要结局
To assess the percentage difference in mean VAS (Visual Analogue Scale) score of perceived pain of local anaesthetic injection between children receiving additional hypnoanaesthesia in combination with standard infiltration anaesthetic technique versus those receiving standard infiltration anaesthetic technique alone during minor dermatosurgical procedures
时间窗: Just after the injection of local anaesthetic agent
次要结局
- To assess the percentage difference in mean VAS score of perceived pain(During & after the surgery)
- To assess the percentage reduction in VAS score of anxiety before & immediately after the hypnoanaesthesia in the intervention arm.(Before & immediately after the hypnoanaesthesia)
- To evaluate the changes in respiratory rate, heart rate & blood pressure before & immediately after the administration of hypnoanaesthesia.(before & immediately after the administration of hypnoanaesthesia)
- To assess the percentage difference in mean VAS score of post-operative pain at the end of 1 week between the control & intervention group(Day 7)
- To assess the percentage difference in mean VAS score of anxiety in parents during the surgical procedure of their child(During the surgical procedure)