Elective Reconstructive Surgery PopulationSleep7NCT01870076
The Effect of Healing Touch on Sleep
A study testing Healing Touch in people with Elective Reconstructive Surgery Population, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity. Read more about this study
- Who is it for?
- Ages 5 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Elective Reconstructive Surgery Population
- What is being tested?
- Healing Touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2015to 3 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Cincinnati, Ohio, 45231
About this study
Official title: Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical
Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.
Read the detailed description
Patients are to randomized into one of 4 treatment groups upon enrollment. Depending on randomization group, the study participant receives the treatment the evening before elective surgery. A polysomnographic sleep study is then completed. Plan is to review the effect of the treatment group on sleep quantity and sleep quality.
- Being tested
- Healing Touch, Healing Touch, Sham, Control, Presence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing TouchBehavioural
Healing Touch, ShamBehavioural
Control, PresenceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Healing Touch Intervention | Experimental | Healing Touch performed one hour prior to bed. Receives: Behavioral: Healing Touch |
| Healing Touch Sham | Sham comparator | Healing Touch Sham provided one hour prior to bed. Receives: Behavioral: Healing Touch, Sham |
| Control, Presence | Active comparator | Control, Presence Intervention in the room one hour prior to bed. Receives: Behavioral: Control, Presence |
| Control, No Presence | No intervention | No Presence in the room one hour prior to bed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Touch Will Improve Total Sleep Time
Data from nocturnal polysomnography, specifically total number of minutes of sleep time, will be compared between the healing touch and non healing touch groups.
Measured: 8 hours
Secondary outcomes (1)
Preoperative Cortisol Level
Cortisol level was compared among the 4 study groups.
Measured: Labs were drawn immediately pre-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study start12 Dec 2015
- Primary completion15 May 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Elective Reconstructive Surgery PopulationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Michele Gottschlich, Shriners Hospitals for Children
- Investigators
- Michele Gottschlich, PhD, Principal investigator, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870076
- Sponsor's protocol ID
- 2015-1253
- Acronym
- Sleep7
- Status last verified
- Oct 2017
- First submitted
- 28 May 2013
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical
- ClinicalTrials.gov ID
- NCT01870076
- Acronym / sponsor ID
- Sleep7 / 2015-1253
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- 12 Dec 2015 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.
Detailed description
Patients are to randomized into one of 4 treatment groups upon enrollment. Depending on randomization group, the study participant receives the treatment the evening before elective surgery. A polysomnographic sleep study is then completed. Plan is to review the effect of the treatment group on sleep quantity and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healing Touch Intervention | Experimental | Behavioral: Healing TouchHealing Touch performed one hour prior to bed. |
| Healing Touch Sham | Sham comparator | Behavioral: Healing Touch, ShamHealing Touch Sham provided one hour prior to bed. |
| Control, Presence | Active comparator | Behavioral: Control, PresenceControl, Presence Intervention in the room one hour prior to bed. |
| Control, No Presence | No intervention | –No Presence in the room one hour prior to bed. |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Healing Touch | Behavioural | Healing Touch Intervention |
| Healing Touch, Sham | Behavioural | Healing Touch Sham |
| Control, Presence | Behavioural | Control, Presence |
Primary outcome
Healing Touch Will Improve Total Sleep Time
Time frame: 8 hours
Data from nocturnal polysomnography, specifically total number of minutes of sleep time, will be compared between the healing touch and non healing touch groups.
1 secondary outcome
Preoperative Cortisol Level
Time frame: Labs were drawn immediately pre-op.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Michele Gottschlich, PhD principal investigator
Shriners Hospitals for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Touch in people with Elective Reconstructive Surgery Population, run by Shriners Hospitals for Children 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 4 inclusion and 7 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 20 Nov 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Healing Touch Will Improve Total Sleep Time (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2017.