Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304, United States
NCT Number: NCT01483105
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.
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Notify Me4 year–12 year
All sexes
Interventional
Not applicable
Palo Alto, California, 94304, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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."
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.
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."
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.
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.
Time frame: Same day - 3 months following procedure
The DVD Evaluation form will ask parents to evaluate the DVD-based training program.
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.
Stanford University
Other
DVD-Based Training Program in Self-Hypnosis for Children: A Randomized Clinical Trial
Acronym: VCUG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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