CompletedNot Applicable

The Effect of Healing Touch on Sleep

United States41 participantsStarted 2015-12-12

Plain-language summary

Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.

Who can participate

Age range

5 Years – 25 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

. 5-25 years of age, inclusive
. Elective admission for a reconstructive operative procedure
. Planned use of general anesthesia during the elective operative procedure
. Written informed consent, assent and Health Insurance Portability and Accountability Act (HIPAA) release signed by parent or legal guardian

Exclusion criteria

. History of anoxic or suspected brain injury
. History of head injury within the last year
. Pre-existing neurological disorder
. History of Reynaud's syndrome
. Intellectual disability or inability to follow directions
. Face/head phenomena that prevent(s) proper placement of polysomnography(PSG) leads
. Taking medication for diagnosis of cardiomyopathy

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

Healing Touch Will Improve Total Sleep Time

Timeframe: 8 hours

Trial details

NCT IDNCT01870076

SponsorShriners Hospitals for Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05-15

Results submitted2017-07-15

View on ClinicalTrials.gov More Elective Reconstructive Surgery Population trials