Using Medical Hypnotherapy in Children With Defecation Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 主要终点
- The primary outcome of this study will be the assessment of distress as measured by the non-blinded observer.
研究概览
简要总结
Partially blinded randomized controlled trial investigating the effect of a brief session of hypnosis prior to anorectal manometry in children
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
A blinded observer assessed child distress during anorectal manometry
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-18 who are scheduled to undergo anorectal manometry testinf.
- •ASA classification I to II.
- •Both parents and children have sufficient English language proficiency.
- •Both parents and children are willing to fill out the questionnaires involved in this study.
排除标准
- •ASA classification III, IV (children with a chronic or severe disease).
- •Children with a metabolic, endocrine or neuromuscular disorder or mental illness.
- •Children with anorectal malformations or previous anorectal surgery.
- •Children with developmental delay
- •Children with diagnosed emotional or behavioral disorders
结局指标
主要结局
The primary outcome of this study will be the assessment of distress as measured by the non-blinded observer.
时间窗: Periprocedural
The non-blinded observer will use the Observation Scale of Behavioral Distress (OSBD) to assess the periprocedural distress of the child. The OSBD records the presence or absence of thirteen operationally-defined behaviors, which indicate discomfort (e.g. cry, verbal resistance, information seeking) at 15-second intervals throughout the procedure. The behaviors are given a score ranging from 1 to 4 according to the severity of distress that is expressed by that behavior. The recorded score during a 15-second interval can range from zero (no distress) to 33.5 (extreme distress). The total scores will be summed up and then divided by the number of 15-second intervals to obtain a mean distress score.
次要结局
- Periprocedural distress as measured by the blinded observer(Periprocedural)
- Child-reported levels of distress(Right after anorectal manometry (same day))
- Parent-reported levels of distress(Right after anorectal manometry (same day))
- Difficulty of procedure(Right after anorectal manometry (same day))
- Difficulty of hypnosis(Right after anorectal manometry (same day))
- Manometry outcomes(Periprocedural)
研究者
Frederick Woodley
PhD
Nationwide Children's Hospital