search
Back to results

DVD-Based Training Program in Self-Hypnosis for Children (VCUG)

Primary Purpose

Vesicoureteral Reflux

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DVD Self-Hypnosis Training Program
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vesicoureteral Reflux focused on measuring VCUG, Child, Hypnosis, Relaxation, Voiding cystourethrography

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lucile Packard Children's Hospital at Stanford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DVD self-hypnosis

Standard care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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."
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.

Secondary Outcome Measures

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."
Anxiety: Parent Self-Report
Parents will complete the State-Trait Anxiety Inventory (Spielberger, 1970) immediately following the procedure.
Parent Confidence
Parent confidence in helping their child through the VCUG procedure will be assessed immediately following the procedure up to 1 week.
DVD Evaluation
The DVD Evaluation form will ask parents to evaluate the DVD-based training program.
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.

Full Information

First Posted
November 18, 2011
Last Updated
May 26, 2022
Sponsor
Stanford University
Collaborators
Lucile Packard Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01483105
Brief Title
DVD-Based Training Program in Self-Hypnosis for Children
Acronym
VCUG
Official Title
DVD-Based Training Program in Self-Hypnosis for Children: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 6, 2012 (Actual)
Study Completion Date
July 6, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Lucile Packard Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesicoureteral Reflux
Keywords
VCUG, Child, Hypnosis, Relaxation, Voiding cystourethrography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DVD self-hypnosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DVD Self-Hypnosis Training Program
Intervention Description
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 Outcome Measure Information:
Title
Distress: Child Self-Report
Description
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
Title
Distress: Parent Report
Description
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
Title
Distress: Observational Ratings
Description
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 Outcome Measure Information:
Title
Difficulty of Procedure: Medical Staff Ratings
Description
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.
Title
Anxiety: Parent Self-Report
Description
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.
Title
Parent Confidence
Description
Parent confidence in helping their child through the VCUG procedure will be assessed immediately following the procedure up to 1 week.
Time Frame
Directly following procedure - 1 week
Title
DVD Evaluation
Description
The DVD Evaluation form will ask parents to evaluate the DVD-based training program.
Time Frame
Same day - 3 months following procedure
Title
Duration of Procedure
Description
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.
Time Frame
Same day - Time can range from minutes - hours of observation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Spiegel, M.D.
Organizational Affiliation
Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda M. Shortliffe, M.D.
Organizational Affiliation
Stanford University School of Medicine, Pediatric Urology
Official's Role
Study Director
Facility Information:
Facility Name
Lucile Packard Children's Hospital at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15629969
Citation
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.
Results Reference
background
Links:
URL
http://stresshealthcenter.stanford.edu/research/projects.html
Description
Study information and contact information
URL
https://stanfordmedicine.qualtrics.com/SE/?SID=SV_e9Rm0i6H0uyxiw4
Description
DVD study screen

Learn more about this trial

DVD-Based Training Program in Self-Hypnosis for Children

We'll reach out to this number within 24 hrs