DVD-Based Training Program in Self-Hypnosis for Children

NCT01483105 | Completed DMC

• 1 other identifier: 6970
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Vesicoureteral Reflux

Keywords

VCUG; Child; Hypnosis; Relaxation; Voiding cystourethrography

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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.

Study Arms (2)

DVD self-hypnosis

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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.

Interventions

DVD Self-Hypnosis Training Program BEHAVIORAL

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.

DVD self-hypnosis

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Lucile Packard Children's Hospital: collaborator

Study Sites (1)

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 15629969 BACKGROUND

Related Links

• DVD study screen

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• David Spiegel, M.D.

  Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

• Linda M. Shortliffe, M.D.

  Stanford University School of Medicine, Pediatric Urology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: December 1, 2011
• Study Start: October 1, 2011
• Primary Completion: July 6, 2012
• Study Completion: July 6, 2012
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

US (1)