DVD-Based Training Program in Self-Hypnosis for Children (VCUG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01483105|
Recruitment Status : Recruiting
First Posted : December 1, 2011
Last Update Posted : May 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Vesicoureteral Reflux||Behavioral: DVD Self-Hypnosis Training Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||DVD-Based Training Program in Self-Hypnosis for Children: A Randomized Clinical Trial|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: DVD self-hypnosis
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
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.
No Intervention: Standard care
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.
- 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.
- 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."
- 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.
- 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."
- 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.
- 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.
- DVD Evaluation [ Time Frame: Same day - 3 months following procedure ]The DVD Evaluation form will ask parents to evaluate the DVD-based training program.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483105
|Contact: Arianna A. Gerry, Ph.D., MPHemail@example.com|
|Contact: Mala Sivapalasingam, MSN, MPH||650-736-8620||MSivapalasingam@LPCH.ORG|
|United States, California|
|Lucile Packard Children's Hospital at Stanford||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Arianna A. Gerry, Ph.D., MPH 650-723-2744 firstname.lastname@example.org|
|Contact: Mala Sivapalasingam, MSN, MPH 650-736-8620 email@example.com|
|Principal Investigator:||David Spiegel, M.D.||Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences|
|Study Director:||Linda M. Shortliffe, M.D.||Stanford University School of Medicine, Pediatric Urology|
|Study Director:||Arianna A. Gerry, Ph.D., MPH||Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences|