Voiding Cystourethrogram (VCUG)Phase 3NCT00226850
Using Hypnosis to Help Children Undergoing a Difficult Medical Procedure
A Phase 3 study testing hypnosis in people with Voiding Cystourethrogram (VCUG), run by Stanford University at 2 sites in United States.
Trial summary
This study examined whether a hypnosis intervention, compared to standard care, could help reduce distress and pain for children undergoing an invasive medical procedure. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Voiding Cystourethrogram (VCUG)
- What is being tested?
- hypnosis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 5 to 18 years
- All sexes
- Child, Adult
Who may be able to join
- The child: (1) was scheduled for an upcoming VCUG ; (2) must have undergone at least one previous VCUG; (3) was at least 4 years of age at the time of the previous VCUG; (4) experienced distress during the previous VCUG; and (5) both child and participating parent were English speaking.
Who cannot join
- Not meeting any of the above criteria.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine
Stanford, California, 94305-5718
Lucile Packard Children's Hospital
Stanford, California, 94305
About this study
This study examined whether a hypnosis intervention, compared to standard care, could help reduce distress and pain for children undergoing an invasive medical procedure.
- Conditions
- Voiding Cystourethrogram (VCUG)
- Being tested
- hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
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 Voiding Cystourethrogram (VCUG)Studies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Lisa D. Butler, Ph.D., Study director, Stanford UniversityDavid Spiegel, M.D., Principal investigator, Stanford UniversityLinda D Shortliffe, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226850
- Sponsor's protocol ID
- 1HUK610
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 27 Sep 2005
- Results posted
- No
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 27 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Hypnosis to Help Children Undergoing a Difficult Medical Procedure
- ClinicalTrials.gov ID
- NCT00226850
- Acronym / sponsor ID
- 1HUK610
- Conditions
- Voiding Cystourethrogram (VCUG)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- First posted
- 27 Sep 2005 (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.
This study examined whether a hypnosis intervention, compared to standard care, could help reduce distress and pain for children undergoing an invasive medical procedure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The child: (1) was scheduled for an upcoming VCUG ; (2) must have undergone at least one previous VCUG; (3) was at least 4 years of age at the time of the previous VCUG; (4) experienced distress during the previous VCUG; and (5) both child and participating parent were English speaking.
Key exclusion criteria (1 listed)
- Not meeting any of the above criteria.
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 |
|---|---|---|
| hypnosis | Behavioural | – |
Primary outcome
Not reported in the source record.
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 27 Sep 2005.
- Results publication: 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.
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.
Lisa D. Butler, Ph.D. study director
Stanford University
David Spiegel, M.D. principal investigator
Stanford University
Linda D Shortliffe, M.D. principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hypnosis in people with Voiding Cystourethrogram (VCUG), run by Stanford University at 2 sites 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 1 inclusion and 1 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 27 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00226850, 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 27 Sep 2005.