DVD-Based Training Program in Self-Hypnosis for Children (NCT01483105) | Clinical Trial Compass
CompletedNot Applicable
DVD-Based Training Program in Self-Hypnosis for Children
United States12 participantsStarted 2011-10
Plain-language 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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Distress: Child Self-Report
Timeframe: Same day - one week after procedure
2
Distress: Parent Report
Timeframe: Same day - one week after procedure
3
Distress: Observational Ratings
Timeframe: Same day - while the child is undergoing the VCUG procedure. Time can range from minutes - hours of observation.