DVD-Based Training Program in Self-Hypnosis for Children

NCT ID: NCT01483105

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-07-06

Brief Summary

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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

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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.

Conditions

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Vesicoureteral Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DVD Self-Hypnosis Training Program

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lucile Packard Children's Hospital

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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David Spiegel

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Spiegel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences

Linda M. Shortliffe, M.D.

Role: STUDY_DIRECTOR

Stanford University School of Medicine, Pediatric Urology

Locations

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Lucile Packard Children's Hospital at Stanford

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15629969 (View on PubMed)

Related Links

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Other Identifiers

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6970

Identifier Type: -

Identifier Source: org_study_id

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