Efficacy of Healing Touch in Stressed Neonates

NCT00034008 | Completed Phase 2

• 1 other identifier: R21AT000734-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to evaluate whether or not Healing Touch therapy (HT) helps to treat the stress of babies in the Neonatal Intensive Care Unit (NICU). Healing Touch is a gentle use of human touch - a light, soft placement without moving of the HT therapist's hand on a baby's body - and energy to create balance and relaxation. The goal of HT treatment is to help babies rest better, have less pain and discomfort and to heal more quickly. Healing Touch works along with all the treatments and medicines babies receive as part of ordinary care in the NICU.

Conditions

Stress

Keywords

Energy Medicine; Healing Touch; CAM Research; Neonates; Stress; Conditions resulting from stress; Neonatal intensive care; Healing of stress and prevention of negative; Developmental outcomes - physical and behavioral; Therapeutic Touch; Touch therapies; Energy therapies; Infant touch; Infant stimulation

Interventions

Healing Touch BEHAVIORAL

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment upon admission to the NICU and up to 7 days after admission
• Admission to the NICU requiring Level III care during the study period (7 days).
• Infants requiring ventilator support within the first 48 hours after admission.
• Infants requiring tube feedings \> 50% of the time at the time of study entry.
• Both term and preterm infants (Any neonate admitted to the NICU - 20+ weeks gestation to term or more.)

You may not qualify if:

• All infants with cyanotic congenital heart disease.
• Other major congenital anomalies requiring immediate surgery.
• Infants admitted for a period predicted to be significantly less than 7 days; if status changes, the infant may be entered at that time.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

University of Arizona, University Medical Center, Neonatal Intensive Care Unit

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Behavior

Interventions

Touch

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sharon I. McDonough-Means, MD

  University of Arizona, College of Medicine, Program in Integrative Medicine and Dept. of Pediatrics

  PRINCIPAL INVESTIGATOR

• Iris R. Bell, MD, PhD

  University of Arizona, Department of Psychiatry and Program in Integrative Medicine, College of Medicine

• Rosemarie Bigsbury, ScD, OTR/L

  Infant Development Center, Department of Pediatrics, Women & Infants' Hospital, Brown University School of Medicine

• Jane Doussard-Roosevelt, PhD

  Department of Human Development, University of Maryland

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 19, 2002
• First Posted: April 22, 2002
• Study Start: July 1, 2003
• Study Completion: July 1, 2004
• Last Updated: August 18, 2006

Record last verified: 2006-07

Locations

US (1)