DVD-Based Training Program in Self-Hypnosis for Children: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Distress: Child Self-Report
研究概览
简要总结
The proposed study is designed to utilize a self-hypnosis DVD home-training program for parents to use with their children to teach self-hypnosis techniques for inducing relaxation and hypnotic analgesia. These relaxation techniques can be employed to manage anticipatory anxiety, distress, and pain during an invasive medical procedure, for example, voiding cystourethrography (VCUG). The study will examine the efficacy of this intervention for children undergoing VCUG procedures.
详细描述
Pediatric care professionals and parents seek safe ways to make invasive medical procedures less stressful and traumatic for children. However, for unpleasant procedures that require child cooperation, this task becomes difficult. Home-training in self-hypnotic relaxation may provide an inexpensive, yet systematic method for improving the overall medical care of children undergoing invasive medical procedures. The proposed study is designed to utilize a self-hypnosis DVD home-training program for parents to use with their children to teach self-hypnosis techniques for inducing relaxation and hypnotic analgesia. The study will examine the efficacy of this intervention for children undergoing urethral catheterization for VCUG procedures. Parents will be instructed to watch the DVD and practice the self-hypnosis exercises every day for a week with their child prior to the upcoming procedure. Parents are encouraged to practice self-hypnosis during their child's VCUG procedure. Both parents and children will be asked to complete a series of questionnaires before and following the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child and participating parent have assented (child) or consented (parent) to participate
- •Both child and parent are English-speaking
- •Child has undergone at least one previous VCUG
- •Child was at least 4 years of age at the time of the most recent VCUG
- •Parent reports child experienced some difficulty (e.g., at least some crying, pain, or fear) during that earlier procedure.
排除标准
- •Child and participating parent have not assented (child) or consented (parent) to participate
- •Either child or parent are not English-speaking
- •Child has not undergone at least one previous VCUG
- •Child was under 4 years of age at the time of the most recent VCUG
- •Parent reports child did not experience difficulty (e.g., at least some crying, pain, or fear) during that earlier procedure.
研究组 & 干预措施
DVD self-hypnosis
This group will receive standard care, and parents/children in this group will receive in the mail a set of questionnaires and the DVD self-hypnosis training program. Parents will be asked to review these materials and practice the training at home with their children for one week leading up to the procedure Parents will also be asked to try to use these techniques with their child during his or her upcoming VCUG procedure.
干预措施: DVD Self-Hypnosis Training Program (Behavioral)
Standard care
Children in this arm will receive standard care and parents/children will be mailed a set of questionnaires to complete before and after your child's upcoming VCUG.
结局指标
主要结局
Distress: Child Self-Report
时间窗: Same day - one week after procedure
Crying will be assessed by having the child point to a picture on a continuous visual analog scale of 6 different faces representing increasing levels of distress, ranging from a smiling face to a face crying intensely.
Distress: Parent Report
时间窗: Same day - one week after procedure
Parent assessments of child distress (fear, pain, and crying)and overall trauma will be completed on 5-point scales, ranging from "not at all" to "extremely". Parents will also rate of how traumatic the present VCUG procedure was compared with the previous one was completed on a 6-point scale ranging from "much less traumatic" to "much more traumatic."
Distress: Observational Ratings
时间窗: Same day - while the child is undergoing the VCUG procedure. Time can range from minutes - hours of observation.
A research associate will rate the child's distress from the time he or she enters the procedure room until the procedure is completed. A modified 8-point version of the Torrance Global Mood Scale will be used.
次要结局
- Difficulty of Procedure: Medical Staff Ratings(Directly following procedure - up to 30 minutes following the end of procedure.)
- Parent Confidence(Directly following procedure - 1 week)
- DVD Evaluation(Same day - 3 months following procedure)
- Duration of Procedure(Same day - Time can range from minutes - hours of observation.)
- Anxiety: Parent Self-Report(Directly following procedure - up to 30 minutes following the end of procedure.)
研究者
David Spiegel
Principle Investigator
Stanford University