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Completed

NCT Number: NCT01483105

DVD-Based Training Program in Self-Hypnosis for Children

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Distress: Child Self-Report

    Time frame: Same day - one week after procedure

    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.

  2. Distress: Parent Report

    Time frame: Same day - one week after procedure

    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."

  3. Distress: Observational Ratings

    Time frame: Same day - while the child is undergoing the VCUG procedure. Time can range from minutes - hours of observation.

    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 outcomes

  1. Difficulty of Procedure: Medical Staff Ratings

    Time frame: Directly following procedure - up to 30 minutes following the end of procedure.

    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."

  2. Anxiety: Parent Self-Report

    Time frame: Directly following procedure - up to 30 minutes following the end of procedure.

    Parents will complete the State-Trait Anxiety Inventory (Spielberger, 1970) immediately following the procedure.

  3. Parent Confidence

    Time frame: Directly following procedure - 1 week

    Parent confidence in helping their child through the VCUG procedure will be assessed immediately following the procedure up to 1 week.

  4. DVD Evaluation

    Time frame: Same day - 3 months following procedure

    The DVD Evaluation form will ask parents to evaluate the DVD-based training program.

  5. Duration of Procedure

    Time frame: Same day - Time can range from minutes - hours of observation.

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Lucile Packard Children's Hospital

Registry information

Official study title

DVD-Based Training Program in Self-Hypnosis for Children: A Randomized Clinical Trial

Acronym: VCUG

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2011
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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