Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034008
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-04-19
Brief Title:
Efficacy of Healing Touch in Stressed Neonates
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Efficacy of Healing Touch in Stressed Neonates
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 therapists hand on a babys 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
Detailed Description:
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 N20 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 HTSOC 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 Sa02b 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None