An interventional study of Massage therapy in Premature Birth of Newborn, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 3 Days to 20 Weeks. Per ClinicalTrials.gov, last updated 2013-06-03.
Sponsored by University of Arkansas · Not applicable, Interventional, and Supportive care
Premature infants sometimes require sedation to ensure minimal movement during diagnostic procedures such as MRIs. However, sedatives may produce adverse effects. The purpose of this two-day study is to determine whether massage therapy will promote sleep in preterm infants and also help them to stay asleep, providing a safer way to sedate infants for procedures. A small instrument called a sleep watch or actigraph will be placed around the infant's ankle to measure muscle activity and provide an indication of sleep. Infants will receive a 10- minute massage on one morning of the study and no massage on the alternate morning. Recordings from the actigraph will show whether there is difference in sleep pattern with and without massage. Infants will be monitored for any heart rate and oxygen saturation changes on both mornings of the study.
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.
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This study's enrollment of 30 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
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
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.
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.
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
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
Time frame: Participants were followed for two days
Number of Infants Sleeping at the End of the Massage Period
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.
Time frame: Minute massage ended
Oxygen Saturation Levels 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.
Time frame: During massage
Heart Rate
Heart rate during massage therapy
Time frame: During massage therapy
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.
| Milestone | Massage Therapy First Day, no Massage Therapy Second Day | No Massage Therapy First Day, Massage Therapy Second Day |
|---|---|---|
| Started | 15 | 15 |
| Completed | 13 | 10 |
| Not completed | 2 | 5 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Discharged before study start | 2 | 2 |
| Withdrew: No quiet alert state | 0 | 1 |
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
| percentage of time spent sleeping | Sleep Efficiency With Massage Therapy | Sleep Efficiency With no Massage Therapy |
|---|---|---|
| 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 ± 20 | 77.8 ± 21.4 |
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.
| percentage of oxygen saturation | Oxygen Saturation During Massage | Oxygen Saturation Without Massage |
|---|---|---|
| Oxygen Saturation Levels During Massage | 99.7 ± 0.7 | 99.3 ± 1.18 |
Heart rate during massage therapy
| beats per minute | Heart Rate During Massage | Heart Rate Without Massage |
|---|---|---|
| Heart Rate | 162.5 ± 12.7 | 169.45 ± 12.86 |
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.
| participants | Massage Therapy | No Massage Therapy |
|---|---|---|
| Number of Infants Sleeping at the End of the Massage Period | 7 | 14 |
Collected over Infants were enrolled in the study three hours per day for two days. They received massage therapy on one day and no massage therapy on the other day (crossover trial). Data were collected for a total period of 1 year, 2 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Massage Therapy | — | 0/30 (0%) | 0/30 (0%) |
| No Massage Therapy | — | 0/30 (0%) | 0/30 (0%) |
| Age, Customized(participants) | Massage Therapy |
|---|---|
| newborn infant >3 days | 30 |
| Sex: Female, Male(Participants) | Massage Therapy |
|---|---|
| Female | 12 |
| Male | 18 |
| Region of Enrollment(participants) | Massage Therapy |
|---|---|
| United States | 30 |
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