DVD-Based Training Program in Self-Hypnosis for Children (VCUG)

This study is currently recruiting participants.
Verified December 2013 by Stanford University
Sponsor:
Collaborator:
Lucile Packard Children's Hospital
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01483105
First received: November 18, 2011
Last updated: December 3, 2013
Last verified: December 2013

November 18, 2011
December 3, 2013
October 2011
December 2014   (final data collection date for primary outcome measure)
  • Distress: Child Self-Report [ Time Frame: Same day - one week after procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: Same day - one week after procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: Same day - while the child is undergoing the VCUG procedure. Time can range from minutes - hours of observation. ] [ Designated as safety issue: No ]
    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 as current
Complete list of historical versions of study NCT01483105 on ClinicalTrials.gov Archive Site
  • Difficulty of Procedure: Medical Staff Ratings [ Time Frame: Directly following procedure - up to 30 minutes following the end of procedure. ] [ Designated as safety issue: No ]
    Immediately after the procedure, the attending radiologist and the technician each will be asked to rate the degree of difficulty of conducting the procedure. Staff will be asked to make the ratings with respect to children of similar ages on a 7-point scale ranging from "far easier" to "far more difficult."
  • Anxiety: Parent Self-Report [ Time Frame: Directly following procedure - up to 30 minutes following the end of procedure. ] [ Designated as safety issue: No ]
    Parents will complete the State-Trait Anxiety Inventory (Spielberger, 1970) immediately following the procedure.
  • Parent Confidence [ Time Frame: Directly following procedure - 1 week ] [ Designated as safety issue: No ]
    Parent confidence in helping their child through the VCUG procedure will be assessed immediately following the procedure up to 1 week.
  • DVD Evaluation [ Time Frame: Same day - 3 months following procedure ] [ Designated as safety issue: No ]
    The DVD Evaluation form will ask parents to evaluate the DVD-based training program.
  • Duration of Procedure [ Time Frame: Same day - Time can range from minutes - hours of observation. ] [ Designated as safety issue: No ]
    Time in minutes of the VCUG procedure will be recorded from when the child first enters the room to when the child is told the procedure is over.
Same as current
Not Provided
Not Provided
 
DVD-Based Training Program in Self-Hypnosis for Children
DVD-Based Training Program in Self-Hypnosis for Children: A Randomized Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Vesicoureteral Reflux
Behavioral: DVD Self-Hypnosis Training Program
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.
  • Experimental: 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.
    Intervention: Behavioral: DVD Self-Hypnosis Training Program
  • No Intervention: 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
4 Years to 12 Years
No
Contact: Arianna A. Gerry, Ph.D., MPH 650-723-2744 aagerry@stanford.edu
Contact: Mala Sivapalasingam, MSN, MPH 650-736-8620 MSivapalasingam@LPCH.ORG
United States
 
NCT01483105
6970
Yes
Stanford University
Stanford University
Lucile Packard Children's Hospital
Principal Investigator: David Spiegel, M.D. Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences
Study Director: Linda M. Shortliffe, M.D. Stanford University School of Medicine, Pediatric Urology
Study Director: Arianna A. Gerry, Ph.D., MPH Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences
Stanford University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP