An interventional study of DVD Self-Hypnosis Training Program in Vesicoureteral Reflux, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-05-31.
Sponsored by Stanford University · Not applicable, Interventional, and Supportive care
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.
28 studies on the registry are indexed under Vesico-Ureteral Reflux; 4 are open to participants now.
This study's enrollment of 12 is below the median of 62 across 20 interventional studies indexed under Vesico-Ureteral Reflux.
Browse Vesico-Ureteral Reflux studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
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.
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.
Parent Confidence
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
DVD Evaluation
The DVD Evaluation form will ask parents to evaluate the DVD-based training program.
Time frame: 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.
Time frame: Same day - Time can range from minutes - hours of observation.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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