Harp music: Effects on heart rate variability, cortisol and activity

ISRCTN	ISRCTN61185493
DOI	https://doi.org/10.1186/ISRCTN61185493
Protocol serial number	NIH AT001901
Sponsor	National Institutes of Health, National Center for Complementary and Alternative Medicine (USA)
Funder	National Institutes of Health (ref: NCCAM AT001901)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Kathi Kemper
Scientific

Wake Forest University School of Medicine
Medical Center Blvd.
Winston-Salem
27157
United States of America

Primary study design	Interventional
Study design	Randomized controlled trial.
Secondary study design	Randomised controlled trial
Scientific title	Harp music: Effects on heart rate variability, cortisol and activity
Study objectives	The null hypothesis is that harp music has no effect compared with usual care or a quiet room on any parameter of heart rate variability, salivary cortisol or activity of premature infants.
Ethics approval(s)	Approved by Wake Forest University School of Medicine (WFUSM) Institutional Review Board on 03/31/2005 (Protocol no. BG05-162)
Health condition(s) or problem(s) studied	Prematurity
Intervention	Harp music vs quiet room. The infants allocated to the intervention group had harp music for 45 minutes each day for 3 days.
Intervention type	Other
Primary outcome measure(s)	1. Salivary cortisol was measured just prior to harp music/quiet/usual care observation period and just after each day 2. HRV was measured during the intervention each day 3. Activity was measured during and after the intervention each day 4. Weight, meausred at baseline (Monday) and 5 days (Friday)
Key secondary outcome measure(s)	Growth, measured as weight gain at 5 days (this trial is 5 days long).
Completion date	30/12/2006

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	90
Total final enrolment	8
Key inclusion criteria	Infants hospitalized at Brenner Children's Hospital Neonatal Intensive Care or Intermediate Care UnitsInfants were eligible if they satisfied the following criteria: 1. Born between 25 and 36 weeks gestational age 2. At least 34 weeks gestational age by the time of enrollment 3. Had been medically stable in the intermediate care nursery for at least three days 4. Had passed the neonatal hearing screen 5. Slept in a crib rather than an isolette 6. Took full oral feedings 7. Free of apnea and bradycardia spells 8. Expected to remain in the intermediate nursery for at least seven more days to achieve stable body temperature
Key exclusion criteria	1. Any medical condition known to adversely affect either: 1.1. Central nervous system (e.g. intraventricular hemorrhage of Grade II or higher) 1.2. Cardiac or adrenal function (e.g. major cardiac anomaly) 1.3. Movement (e.g. spasticity, hypotonia, or fractured clavicle) 2. Any ongoing need for stressful or invasive medical procedures or steroid medications
Date of first enrolment	01/04/2005
Date of final enrolment	30/12/2006

Wake Forest University School of Medicine

Winston-Salem
27157
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2008	17/05/2019	Yes	No

17/05/2019: Publication reference and total final enrolment added.