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

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.

Study Overview

• Status: Completed
• Conditions: Vesicoureteral Reflux
• Intervention / Treatment: Behavioral: DVD Self-Hypnosis Training Program

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital at Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulty of Procedure: Medical Staff Ratings	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."	Directly following procedure - up to 30 minutes following the end of procedure.
Anxiety: Parent Self-Report	Parents will complete the State-Trait Anxiety Inventory (Spielberger, 1970) immediately following the procedure.	Directly following procedure - up to 30 minutes following the end of procedure.
Parent Confidence	Parent confidence in helping their child through the VCUG procedure will be assessed immediately following the procedure up to 1 week.	Directly following procedure - 1 week
DVD Evaluation	The DVD Evaluation form will ask parents to evaluate the DVD-based training program.	Same day - 3 months following procedure
Duration of Procedure	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 day - Time can range from minutes - hours of observation.

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study information and contact information
• DVD study screen

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 6, 2012
• Study Completion (Actual): July 6, 2012

Study Registration Dates

• First Submitted: November 18, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Child; Hypnosis; Relaxation; VCUG; Voiding cystourethrography
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Vesico-Ureteral Reflux
• Other Study ID Numbers: 6970