DVD-Based Training Program in Self-Hypnosis for Children
- Conditions
- Vesicoureteral Reflux
- Interventions
- Behavioral: DVD Self-Hypnosis Training Program
- Registration Number
- NCT01483105
- Lead Sponsor
- Stanford University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DVD self-hypnosis DVD Self-Hypnosis Training Program 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.
- Primary Outcome Measures
Name Time Method Distress: Child Self-Report 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 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 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.
- Secondary Outcome Measures
Name Time Method Difficulty of Procedure: Medical Staff Ratings 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."
Parent Confidence 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 Same day - 3 months following procedure The DVD Evaluation form will ask parents to evaluate the DVD-based training program.
Duration of Procedure 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.
Anxiety: Parent Self-Report 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.
Trial Locations
- Locations (1)
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States