The Role of Audio-recorded Gut-hypnotherapy on Sleep Disturbance, Sleep-related Impairment and Abdominal Pain in Pediatric Functional Abdominal Pain Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Feasibility of adherence and satisfaction to hypnotherapy treatment protocol
研究概览
简要总结
Children with irritable bowel syndrome (IBS) and functional abdominal pain- not otherwise specified (FAP-NOS) have higher rates of poor sleep quality. This can be associated with worse abdominal pain and quality of life, but few treatments target sleep. Gut-directed hypnotherapy (GDH) has been shown to reduce abdominal pain and has been hypothesized to improve sleep, but this has not been studied. This study investigates the use of a home-based audio program of GDH as a feasibility intervention for children and whether it can also help with sleep quality. Children aged 8-18 with IBS or FAP-NOS were enrolled from three children's hospitals. Participants in one group completed 6 weeks of GDH sessions at home. Sleep, abdominal pain, and daily functioning were tracked through online surveys. Participants in the control group continued their usual medical care first, and then crossed over into the GDH program.
详细描述
Children with pain-predominant disorders of gut-brain interaction (DGBI) including irritable bowel syndrome (IBS) and functional abdominal pain-not otherwise specified (FAP-NOS) frequently experience sleep-related impairment, which is linked to increased pain severity, functional disability, and health care utilization. Gut-directed hypnotherapy (GDH) is an evidence-based treatment for pediatric DGBI that has been hypothesized to improve sleep, although this has not been studied. This pilot randomized controlled trial evaluates the feasibility of implementing a 6-week, audio-guided GDH program at home and explores effect sizes for sleep, abdominal pain, quality of life, and anxiety outcomes. Children ages 8-18 meeting Rome IV criteria for IBS or FAP-NOS and at least mild sleep disturbance or sleep impairment were recruited virtually from three pediatric gastroenterology centers. Participants were randomized to either standard medical therapy (SMT) or GDH; SMT participants crossed over to GDH after 6 weeks. Primary outcomes were feasibility as measured by adherence, interest, and satisfaction and sleep effect size. Secondary exploratory aims included abdominal pain, functional disability, and anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •ages 8 to 18 years
- •met Rome IV criteria for FAP-NOS or IBS
- •abdominal pain severity >3/10 in the past 2 weeks
- •minimum of 1 day of pain in the past 2 weeks
- •mild SRI and/or SD as determined by the PROMIS 4- question short-form questionnaires
- •stable medication regimen or dietary therapy for >2 weeks prior to enrollment
排除标准
- •disability that could hinder their understanding of the audio material
- •previous experience with guided imagery for treatment of abdominal pain
- •psychiatric disorder with psychotic elements such as dissociative symptoms
- •other chronic gastrointestinal disease including inflammatory bowel disease, celiac disease, or eosinophilic esophagitis
- •other chronic inflammatory conditions
- •previous gastrointestinal surgery
- •a diagnosis of a sleep disorder such as narcolepsy or sleep apnea.
结局指标
主要结局
Feasibility of adherence and satisfaction to hypnotherapy treatment protocol
时间窗: This was assessed throughout the 6 week course by completion of daily abdominal pain surveys and at the end of the 6 week hypnotherapy course.
Feasibility was measured through treatment adherence and participant satisfaction. Adherence was measured by number of pre-audio surveys completed and self-reported number of audios completed per week. A 5-point likert scale was used to determine enrolled participant satisfaction with hypnotherapy at the end of the intervention.
Treatment effect size for Sleep Quality as measured by PROMIS Questionnaire for sleep-related impairment and sleep disturbance
时间窗: enrollment to the end of the 3-month follow up period
Patient- reported outcomes measurement information system (PROMIS) sleep related impairment and sleep disturbance surveys were used to measure sleep quality. This scale produces T-scores ranging from about 25-75, normalized to a population mean of 50 and a standard devision of 10. For this measure, a higher T-score indicates a greater severity of sleep related impairment or sleep disturbance.
次要结局
- Abdominal pain(enrollment to the end of the 3-month follow up period)
- Functional disability(enrollment to the end of the 3-month follow up period)
- Anxiety(enrollment to the end of the 3-month follow up period)
研究者
Lily Barash
Physician
Children's Hospital at Montefiore