Vesicoureteral RefluxVCUGNCT01483105
DVD-Based Training Program in Self-Hypnosis for Children
A study testing DVD Self-Hypnosis Training Program in people with Vesicoureteral Reflux, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Vesicoureteral Reflux
- What is being tested?
- DVD Self-Hypnosis Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to 6 Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
About this study
Official title: DVD-Based Training Program in Self-Hypnosis for Children: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Vesicoureteral Reflux
- Being tested
- DVD Self-Hypnosis Training Program
- Keywords
- VCUG, Child, Hypnosis, Relaxation, Voiding cystourethrography
- Medical subject headings
- Vesico-Ureteral Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVD Self-Hypnosis Training ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DVD self-hypnosis | Experimental | 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. Receives: Behavioral: DVD Self-Hypnosis Training Program |
| Standard care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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."
Measured: 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.
Measured: Same day - while the child is undergoing the VCUG procedure. Time can range from minutes - hours of observation.
Secondary outcomes (5)
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."
Measured: 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.
Measured: 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.
Measured: Directly following procedure - 1 week
DVD Evaluation
The DVD Evaluation form will ask parents to evaluate the DVD-based training program.
Measured: 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.
Measured: Same day - Time can range from minutes - hours of observation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startOct 2011
- Primary completion6 Jul 2012
- Study completion6 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vesicoureteral RefluxStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Lucile Packard Children's Hospital
- Responsible party
- Principal investigator, David Spiegel, Stanford University
- Investigators
- David Spiegel, M.D., Principal investigator, Stanford University School of Medicine, Department of Psychiatry and Behavioral SciencesLinda M. Shortliffe, M.D., Study director, Stanford University School of Medicine, Pediatric Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483105
- Sponsor's protocol ID
- 6970
- Acronym
- VCUG
- Status last verified
- May 2022
- First submitted
- 18 Nov 2011
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15629969
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DVD-Based Training Program in Self-Hypnosis for Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01483105
- Acronym / sponsor ID
- VCUG / 6970
- Conditions
- Vesicoureteral Reflux
- Keywords
- VCUG, Child, Hypnosis, Relaxation, Voiding cystourethrography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Lucile Packard Children's Hospital
- Study start
- Oct 2011
- Primary completion
- 6 Jul 2012 (actual)
- Study completion
- 6 Jul 2012 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DVD self-hypnosis | Experimental | Behavioral: DVD Self-Hypnosis Training ProgramThis 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. |
| Standard care | No intervention | –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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DVD Self-Hypnosis Training ProgramThe 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. | Behavioural | DVD self-hypnosis |
Primary outcome
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.
5 secondary outcomes
Difficulty of Procedure: Medical Staff Ratings
Time frame: Directly following procedure - up to 30 minutes following the end of procedure.
Anxiety: Parent Self-Report
Time frame: Directly following procedure - up to 30 minutes following the end of procedure.
Parent Confidence
Time frame: Directly following procedure - 1 week
DVD Evaluation
Time frame: Same day - 3 months following procedure
Duration of Procedure
Time frame: Same day - Time can range from minutes - hours of observation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Background: PubMed 15629969Butler 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.
- DVD study screenLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Spiegel, M.D. principal investigator
Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences
Linda M. Shortliffe, M.D. study director
Stanford University School of Medicine, Pediatric Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVD Self-Hypnosis Training Program in people with Vesicoureteral Reflux, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress: Child Self-Report (time frame: Same day - one week after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01483105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.