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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Vesicoureteral Reflux
Behavioral: DVD Self-Hypnosis Training Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: DVD-Based Training Program in Self-Hypnosis for Children: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 56
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

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

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483105

Contacts
Contact: Arianna A. Gerry, Ph.D., MPH 650-723-2744 aagerry@stanford.edu
Contact: Mala Sivapalasingam, MSN, MPH 650-736-8620 MSivapalasingam@LPCH.ORG

Locations
United States, California
Lucile Packard Children's Hospital at Stanford Recruiting
Palo Alto, California, United States, 94304
Contact: Arianna A. Gerry, Ph.D., MPH    650-723-2744    aagerry@stanford.edu   
Contact: Mala Sivapalasingam, MSN, MPH    650-736-8620    msivapalasingam@lpch.org   
Sponsors and Collaborators
Stanford University
Lucile Packard Children's Hospital
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01483105     History of Changes
Other Study ID Numbers: 6970
Study First Received: November 18, 2011
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
VCUG
Child
Hypnosis
Relaxation
Voiding cystourethrography

Additional relevant MeSH terms:
Vesico-Ureteral Reflux
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014