DVD-Based Training Program in Self-Hypnosis for Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vesicoureteral Reflux

Intervention / Treatment
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* Behavioral: DVD Self-Hypnosis Training Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DVD self-hypnosis<br>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<br>* 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.<br>|
| No Intervention: Standard care<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VCUG, Child, Hypnosis, Relaxation, Voiding cystourethrography