DVD-Based Training Program in Self-Hypnosis for Children

Vesicoureteral Reflux Clinical Trial

— VCUG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483105
• Other study ID #: 6970
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: July 6, 2012

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 6, 2012
• Est. primary completion date: July 6, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vesico-Ureteral Reflux
• Vesicoureteral Reflux

Intervention

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.

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital at Stanford	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Lucile Packard Children's Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	DVD Evaluation	The DVD Evaluation form will ask parents to evaluate the DVD-based training program.	Same day - 3 months following procedure
Secondary	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.

External Links

•   DVD study screen
•   Study information and contact information