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.
Stress is an inherent part of the experience for the neonate who is critically ill and
unstable during the initial days in the Neonatal Intensive Care Unit (NICU). Individualized
developmentally appropriate nursing care is standard of care (SOC) and provides significant
reduction in stressful stimulation. Developmentally appropriate, nurturing stimulation is
often lacking. Touch is critical in development of neonatal self-regulation. Healing Touch
(HT), a gentle touch and energy healing therapy, is proposed to ameliorate stress and
enhance regulatory system development. This R21 feasibility study will involve 40
critically-ill neonates on admission to the NICU, in a parallel, randomized controlled
trial, single blind design of 2 groups (N=20 each). In each day for a total of 7 days, each
subject will have 2 study conditions: a significant, routinely-occurring, specified stressor
followed immediately by either HT+SOC or SOC alone. The treated group will have HT + SOC
following a stressor for one study condition and SOC alone for the second study condition;
the SOC group will have only SOC for both study conditions. This design allows the treated
group to be paired to its own control on each day. During each study condition, markers of
stress response will be collected: physiological [heart rate (HR), respiratory rate (RR),
oxygen saturation (Sa02) and respiratory sinus arrhythmia (RSA) for cardiac vagal tone
(Vna)] and behavioral [Brazelton states 1-6 and cues (self-regulatory and stress) per
Bigsby]. The primary hypotheses (all in comparison to SOC alone) are: a) HT will result in
improved stress recovery within each study condition, reflected by HR, RR, and Sa02;.b) HT
will result in an accumulative improvement in the stress response from day 1-7, reflected by
HR, RR and Sa02; c) In infants > 30 weeks gestation, HT will result in + _ improved stress
response within each study condition, reflected by increased amplitude of RSA and increased
cardiac vagal tone (Vna), or stress reactivity; and d) In infants > 30 weeks gestation, HT
will result in an accumulative + _ improvement in the stress response from day 1-7,
reflected by increased amplitude of RSA and increased cardiac vagal tone (Vna) both in
stress reactivity (measured during the stress response) and in stress vulnerability
(measured during sleep). Secondary hypotheses are: a) HT will result in improved neonatal
behavioral state and cues during stress recovery within each study condition, as compared
with standard of care alone; b) HT will result in accumulative improvement in behavior from
day 1-7, during the stress response, as reflected by decrease in stress cues, increased
self-regulatory cues, more relaxed behavioral state or decreased frequency of state change.
Data analysis will be done using comparison measures [paired, grouped and multiple T-tests].
To assess the data longitudinally, a general linear mixed model will be used; [repeated
measures analysis of variance and GEE model]. This study will begin our research in
enhancement of neonatal regulatory system development and response to stress and will lay a
foundation for larger scale prospective effectiveness and mechanism studies.
- 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.)
- 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.
- Any infant whose critical care precludes the presence of the Healing Touch
practitioner at the bedside – a temporary exclusion.
- No exclusion due to race or ethnicity – other than the language barrier for true
consent mentioned above.