Clinical trial NCT01483105: DVD-Based Training Program in Self-Hypnosis for Children
Official title: DVD-Based Training Program in Self-Hypnosis for Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vesicoureteral Reflux
Keywords: VCUG
Child
Hypnosis
Relaxation
Voiding cystourethrography
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Lucile Packard Children's Hospital
First posted: 2011-12-01
Enrollment: 12
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Distress: Child Self-Report
timeFrame: Same day - one week after procedure
measure: Distress: Parent Report
timeFrame: Same day - one week after procedure
measure: Distress: Observational Ratings
timeFrame: Same day - while the child is undergoing the VCUG procedure. Time can range from minutes - hours of observation.
Secondary outcomes:
measure: Difficulty of Procedure: Medical Staff Ratings
timeFrame: Directly following procedure - up to 30 minutes following the end of procedure.
measure: Anxiety: Parent Self-Report
timeFrame: Directly following procedure - up to 30 minutes following the end of procedure.
measure: Parent Confidence
timeFrame: Directly following procedure - 1 week
measure: DVD Evaluation
timeFrame: Same day - 3 months following procedure
measure: Duration of Procedure
timeFrame: Same day - Time can range from minutes - hours of observation.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
Study officials:
affiliation: Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences
name: David Spiegel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University School of Medicine, Pediatric Urology
name: Linda M. Shortliffe, M.D.
role: STUDY_DIRECTOR
References:
citation: Butler LD, Symons BK, Henderson SL, Shortliffe LD, Spiegel D. Hypnosis reduces distress and duration of an invasive medical procedure for children. Pediatrics. 2005 Jan;115(1):e77-85. doi: 10.1542/peds.2004-0818.