title: A double-blind randomized controlled pilot trial examining the safety and efficacy of therapeutic touch in premature infants.
abstract: OBJECTIVE
  To explore the hypothesis that nontouch therapy such as therapeutic touch (TT) reduces stress to a clinically important degree and is safe to use in preterm infants.
  
  
  METHODS
  A pilot randomized, double-blind, controlled trial.
  
  
  METHODS
  Two groups of 10 infants were enrolled and randomly assigned to treatment or nontreatment groups. Gestational age was less than 29 weeks. Demographic descriptions of the 2 groups were statistically similar.
  
  
  METHODS
  The observer and staff were blinded to assignment; the TT practitioner was blinded to observed measurements. Each infant received either TT or no therapeutic touch (NTT) for 5 minutes on 3 consecutive days at the same time of day, behind a curtain. Heart period variability (HPV) was measured 5 minutes before, during, and after the treatment phase.
  
  
  RESULTS
  Examination of the parameters of oxygen saturation and episodes of apnea demonstrated no increase in adverse events in TT group compared with NTT group. Repeated-measures multivariate analysis of variance on HPV revealed differences in the interaction of group assignment with low-frequency, high-frequency, and low-to-high- frequency ratio interaction (F2,143 = 8.076, P = .000) and for group, day, and low-frequency, high-frequency, and low-to-high-frequency ratio (F2,288 = 3.146, P = .015), and in the posttreatment time period (F1,16 = 6.259, P = .024), reflective of greater parasympathetic activity in TT group.
  
  
  CONCLUSIONS
  In this pilot trial, HPV showed an increase for the TT group compared with the NTT group. The study reveals no adverse effects of TT in preterm infants.
authors.affiliation: Neonatal Nurseries, McMaster Children's Hospital, Hamilton Health Sciences, Hamilton, Ontario, Canada. julie4453@cogeco.ca
authors.forename: Julie Anne
authors.initials: JA
authors.lastname: Whitley
authors.forename: Bonnie L
authors.initials: BL
authors.lastname: Rich
mesh_terms: D000704:Analysis of Variance; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000628:therapy*; D007234:Infant, Premature; D008297:Male; D010865:Pilot Projects; D019124:Therapeutic Touch; D016896:Treatment Outcome