Effects of Massage Therapy to Induce Sleep in Preterm Infants
|ClinicalTrials.gov Identifier: NCT01354028|
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : June 3, 2013
Last Update Posted : June 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth of Newborn||Other: Massage therapy||Not Applicable|
This cross-over trial pilot study will assess the effectiveness of massage therapy for inducing and maintaining sleep in preterm infants. Massage therapy promotes relaxation and lowers stress levels, evidenced by increased vagal activity and lower cortisol levels. Safer methods of inducing sleep without drugs would be beneficial for infants who require sedation for diagnostic studies. The sample will include infants over 3 days old and between 32-40 weeks adjusted gestational age in a Neonatal Intensive Care Unit (NICU). Infants who are clinically unstable, require surgery, have major congenital anomalies or have a history of severe birth asphyxia will be excluded.
After parental consent, infants will be randomized to receive massage on study day 1 or study day 2. Standard care will be provided on the alternate study day. A minimum of 30 infants is required to complete the study. The primary outcome measure used to document the response to massage will measured by the Motionlogger® Micro Sleep Watch® Actigraph (Actigraph). The actigraph will be placed on the infant's ankle approximately following the 9 am feed and will record lower extremity activity until approximately the 12 pm feed. Massages will occur after a minimum of 30 minutes following the morning feeding when the infant is in a quiet alert state and will be approximately 10 minutes in length. Baby lotion used as standard care in the NICU will be used to facilitate ease of massage.
Primary outcome measures will include data recorded by the actigraph: (a) sleep onset following massage intervention, (b) sleep end time, (c) number of awakenings and duration of awakenings during the study interval, (d) the duration of the longest sustained sleep period, and (e) sleep efficiency. Secondary outcomes will include oxygen saturation and heart rate during massage and for 30 minutes after massage.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Massage Therapy to Induce Sleep in Preterm Infants|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: Massage therapy
Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
Other: Massage therapy
An overall massage time of approximately 10 minutes, administered by physical therapists. Almond oil or baby lotion that is currently used in standard care in the ACH NICU will be used to assist with ease of skin to skin contact during moderate pressure massage. Infants will receive two repetitions of 5-1minute periods of 12 strokes lasting approximately 5 seconds each described in protocol. Actigraph device is on infant's ankle to measure sleep.
No Intervention: No massage therapy
This was a crossover trial with two arms. On one day, infants received massage therapy for 10 minutes. On the other day, infants were monitored as usual with the Actigraph to measure sleep efficiency, but received no massage therapy. This was the control or no intervention arm.
- 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 [ Time Frame: Participants were followed for two days ]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
- Number of Infants Sleeping at the End of the Massage Period [ Time Frame: Minute massage ended ]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.
- Oxygen Saturation Levels During Massage [ Time Frame: During massage ]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.
- Heart Rate [ Time Frame: During massage therapy ]Heart rate during massage therapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354028
|United States, Arkansas|
|Arkansas Children's Hospital|
|Little Rock, Arkansas, United States, 72202|
|Principal Investigator:||Richard W Hall, M.D.||University of Arkansas|