Project Title:	Massaging Therapy Before Preterm Infant Heelsticks
Principal Investigator/Program Director:	Tiffany Field, Ph.D.
Other Investigators and Departments (or other Universities, if applicable):	Miguel Diego, Ph.D.
Community Based Organization-Collaborator (if applicable)	NA
Funding Source (e.g., NICHD, NCI, Dept of Education, Children’s Trust):	NCCAM
Annual Direct Costs:	$150,000
Annual Facility and Administration Costs (F&A) and Rate, (e.g., 53%, 10%):	53%
Total Project Award (Combined Direct and F&A Costs):	$459,000
Dates of Award (if pending, indicated Pending):	Pending
Lay Abstract (in space below): Please be concise (space below will word wrap and expand)	Please include: (a) Specific Aims, Objectives, and/or Hypotheses of the study; (b) Participants (disease or disability, age, gender, child, family, etc), (c) Project type (eg., descriptive study, service demonstration project, case study, ethnographic study, clinical trial); (d) Brief description of methods and procedures; and (e) anticipated outcomes/benefits
Preterm neonates in Neonatal Intensive Care Units show distress and physiological disorganization following their frequent heelsticks for blood draws. Several studies have documented the pain-alleviating effects of non-nutritive sucking (pacifier use) and sucrose during heelsticks. Some have suggested, however, that these procedures interfere with breastfeeding, highlighting the need for finding still another intervention. Massage therapy might alleviate the acute pain of heelsticks. The first aim of this study is to measure the pain-alleviating effects of a brief leg massage prior to the heelstick procedure. Pilot data from our lab suggest that distressed facial expressions and heart rate are reduced when a brief massage is applied prior to the removal of electrodes, a similarly painful procedure. The second aim is to establish the feasibility of phlebotomists applying massage prior to the heelstick procedure by videotaping the heelstick for compliance and effectiveness. A third aim of the study is to explore mediating variables for the massage-pain alleviating effects. Neonatologists are more likely to adopt procedures when underlying mechanisms have been investigated. The model we will explore is based on variables that have already been associated with pain including heart rate, vagal activity, cortisol, substance P and oxytocin. We expect that the massage group would show less facial distress and lower heart rate than the hands-on only group during heelsticks, and their blood samples would contain higher levels of oxytocin. Using the new paper test for saliva, we would also expect lower cortisol and substance P levels during the heelsticks that were preceded by massage. Three of our staff phlebotomists would be trained in the brief, simple-to-administer massage (two minutes). 120 preterm neonates would be randomly assigned to a massage or a simple hand-on-leg touch/attention control group. Group comparisons would be made by a MANOVA followed by ANOVAS on vagal activity, cortisol, substance P, oxytocin, and the distress facial expressions and heart rate during and following the heelstick. The effects of the therapy and the mediating variables (vagal activity, cortisol, substance P and oxytocin) will be assessed by regression analyses on pain reduction (facial distress and heart rate). Massage could then be used as a cost-effective therapy prior to painful NICU procedures.
Abstracts and/or Publications Resulting from the Project: