Trial Outcomes & Findings for Effects of Massage Therapy to Induce Sleep in Preterm Infants (NCT NCT01354028)
NCT ID: NCT01354028
Last Updated: 2013-06-03
Results Overview
Sleep onset following the first quiet alert state after the 9 AM feed Sleep end time Number of awakenings and duration of the awakenings during the study period Longest sustained sleep period for the study interval Percentage of time spent sleeping, or sleep efficiency, will be used to summarize the data, comparing sleep efficiency over 2 days and using each infant as his/her own control
COMPLETED
NA
30 participants
Participants were followed for two days
2013-06-03
Participant Flow
Infants were recruited from the Neonatal Intensive Care Unit (NICU) at a Children's Hospital. Recruitment dates were 03/09/2011 to 05/09/2012. A total of 30 infants were enrolled.
Seven infants were enrolled but did not complete the study. Two infants developed medical complications before the study and therefore became ineligible. Four infants were discharged before the study began. One infant did not have a quiet alert state after feeding and the study was discontinued at that point with no data collected.
Participant milestones
| Measure |
Massage Therapy First Day, no Massage Therapy Second Day
Day one of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
Day two of study: No massage therapy. Actigraph in place to measure sleep for 3 hours
|
No Massage Therapy First Day, Massage Therapy Second Day
Day one of study: No massage therapy. Actigraph in place to measure sleep for 3 hours.
Day two of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Massage Therapy First Day, no Massage Therapy Second Day
Day one of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
Day two of study: No massage therapy. Actigraph in place to measure sleep for 3 hours
|
No Massage Therapy First Day, Massage Therapy Second Day
Day one of study: No massage therapy. Actigraph in place to measure sleep for 3 hours.
Day two of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Discharged before study start
|
2
|
2
|
|
Overall Study
No quiet alert state
|
0
|
1
|
Baseline Characteristics
Effects of Massage Therapy to Induce Sleep in Preterm Infants
Baseline characteristics by cohort
| Measure |
Massage Therapy
n=30 Participants
Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
|
|---|---|
|
Age, Customized
newborn infant >3 days
|
30 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for two daysPopulation: A convenient number of participants was selected for this pilot study.
Sleep onset following the first quiet alert state after the 9 AM feed Sleep end time Number of awakenings and duration of the awakenings during the study period Longest sustained sleep period for the study interval Percentage of time spent sleeping, or sleep efficiency, will be used to summarize the data, comparing sleep efficiency over 2 days and using each infant as his/her own control
Outcome measures
| Measure |
Sleep Efficiency With Massage Therapy
n=23 Participants
Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
|
Sleep Efficiency With no Massage Therapy
n=23 Participants
No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
|
|---|---|---|
|
Quality of Sleep, Defined by Number and Duration of Awakenings, and Longest Sustained Sleep Period for the Study Interval. These Data Were Measured by the Actigraph Software and Summarized as Percentage of Time Spent Sleeping, or Sleep Efficiency
|
78.7 percentage of time spent sleeping
Standard Deviation 20 • Interval -3.5 to 12.9
|
77.8 percentage of time spent sleeping
Standard Deviation 21.4
|
PRIMARY outcome
Timeframe: Minute massage endedPopulation: A convenient number of infants was determined for this pilot study
Investigators compared the number of infants sleeping at the end of the massage period with the percentage of infants sleeping at the same time on the non massage day.
Outcome measures
| Measure |
Sleep Efficiency With Massage Therapy
n=23 Participants
Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
|
Sleep Efficiency With no Massage Therapy
n=23 Participants
No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
|
|---|---|---|
|
Number of Infants Sleeping at the End of the Massage Period
|
7 participants
|
14 participants
|
SECONDARY outcome
Timeframe: During massagePopulation: We determined a convenient size for this pilot study
Infants in the NICU are routinely attached to pulse oximeter monitors that measure oxygen saturation continuously. If the infant is stressed, oxygen levels may drop. Oxygen saturation was monitored during massage therapy as a routine measure but also to ensure that infants did not become stressed during the massage.
Outcome measures
| Measure |
Sleep Efficiency With Massage Therapy
n=23 Participants
Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
|
Sleep Efficiency With no Massage Therapy
n=23 Participants
No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
|
|---|---|---|
|
Oxygen Saturation Levels During Massage
|
99.7 percentage of oxygen saturation
Standard Deviation 0.7 • Interval 98.0 to 99.0
|
99.3 percentage of oxygen saturation
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: During massage therapyPopulation: A convenient size was determined for this pilot study
Heart rate during massage therapy
Outcome measures
| Measure |
Sleep Efficiency With Massage Therapy
n=23 Participants
Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
|
Sleep Efficiency With no Massage Therapy
n=23 Participants
No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
|
|---|---|---|
|
Heart Rate
|
162.5 beats per minute
Standard Deviation 12.7
|
169.45 beats per minute
Standard Deviation 12.86
|
Adverse Events
Massage Therapy
No Massage Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Richard W Hall MD, Professor of Neonatology
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place