DVD-Based Training Program in Self-Hypnosis for Children

Stanford University12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Vesicoureteral Reflux

Interventions

DVD Self-Hypnosis Training ProgramBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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."

Time frame: 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.

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

Secondary Outcomes

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."

Time frame: 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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.