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Completed

NCT Number: NCT01870076

The Effect of Healing Touch on Sleep

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

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Key information

Conditions

Elective Reconstructive Surgery Population

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shriners Hospitals for Children

Cincinnati, Ohio, 45231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healing Touch

Behavioral

Healing Touch, Sham

Behavioral

Control, Presence

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. Preoperative Cortisol Level

    Time frame: Labs were drawn immediately pre-op.

    Cortisol level was compared among the 4 study groups.

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati

Registry information

Official study title

Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical

Acronym: Sleep7

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2013
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.