NCT01483105|CompletedDMC
DVD-Based Training Program in Self-Hypnosis for Children
VCUG
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VCUG
Sponsor study identifier
interventional
12
1 country
1
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 6, 2012
Actual (reported)Study Completion
July 6, 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 6, 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 18, 2011
Actual (reported)December 1, 2011
Actual (reported)July 6, 2012
Actual (reported)July 6, 2012
Actual (reported)Distress: Child Self-Report
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.
Same day - one week after procedure
Distress: Parent Report
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."
Same day - one week after procedure
Distress: Observational Ratings
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.
Same day - while the child is undergoing the VCUG procedure. Time can range from minutes - hours of observation.
Difficulty of Procedure: Medical Staff Ratings
Directly following procedure - up to 30 minutes following the end of procedure.
Anxiety: Parent Self-Report
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.
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.
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.
The DVD training program contains instructional materials developed by an experienced psychiatrist and psychologist at the Department of Psychiatry at Stanford University School of Medicine. Parents will be instructed to review these materials, 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304, United States
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.
David Spiegel, M.D.
Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences
Linda M. Shortliffe, M.D.
Stanford University School of Medicine, Pediatric Urology
12 participants (actual enrollment reported by the registry).
First Submitted
November 18, 2011
First Posted
December 1, 2011
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
Contact the study team to confirm eligibility.
Primary Completion
July 6, 2012
Actual (reported)Study Completion
July 6, 2012
Actual (reported)Last Updated
May 31, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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