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Effects of Massage Therapy to Induce Sleep in Preterm Infants

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ClinicalTrials.gov Identifier: NCT01354028
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : June 3, 2013
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Premature Birth of Newborn
Intervention Other: Massage therapy
Enrollment 30
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Massage Therapy First Day, no Massage Therapy Second Day No Massage Therapy First Day, Massage Therapy Second Day
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 15 15
Completed 13 10
Not Completed 2 5
Reason Not Completed
Physician Decision             0             2
Discharged before study start             2             2
No quiet alert state             0             1
Arm/Group Title Massage Therapy
Hide Arm/Group Description Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
newborn infant >3 days Number Analyzed 30 participants
30
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
12
  40.0%
Male
18
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
A convenient number of participants was selected for this pilot study.
Arm/Group Title Sleep Efficiency With Massage Therapy Sleep Efficiency With no Massage Therapy
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: percentage of time spent sleeping
78.7  (20) 77.8  (21.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sleep Efficiency With Massage Therapy, Sleep Efficiency With no Massage Therapy
Comments

Null hypothesis: there will be no difference in sleep efficiency in preterm infants on the day of massage versus the day without massage.

Power calculation: the sample size was determined by convenience for this pilot study

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1303
Comments [Not Specified]
Method Chi-squared
Comments Degrees of freedom =1
2.Primary Outcome
Title Number of Infants Sleeping at the End of the Massage Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
A convenient number of infants was determined for this pilot study
Arm/Group Title Massage Therapy No Massage Therapy
Hide Arm/Group Description:
Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
Overall Number of Participants Analyzed 23 23
Measure Type: Number
Unit of Measure: participants
7 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Massage Therapy, No Massage Therapy
Comments

Null hypothesis: there is no difference in massage therapy or no massage therapy in number of infants who will be asleep at the end of massage or the corresponding time frame on the non massage day.

Pearson's chi square=4.98

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments Pearson's chi square
Method Chi-squared
Comments Degrees of freedom=1
3.Secondary Outcome
Title Oxygen Saturation Levels During Massage
Time Frame During massage
Hide Outcome Measure Data
Hide Analysis Population Description
We determined a convenient size for this pilot study
Arm/Group Title Oxygen Saturation During Massage Oxygen Saturation Without Massage
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Oxygen saturation during massage therapy
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 heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: percentage of oxygen saturation
99.7  (0.7) 99.3  (1.18)
4.Secondary Outcome
Title Heart Rate
Hide Description Heart rate during massage therapy
Time Frame During massage therapy
Hide Outcome Measure Data
Hide Analysis Population Description
A convenient size was determined for this pilot study
Arm/Group Title Heart Rate During Massage Heart Rate Without Massage
Hide Arm/Group Description:
Heart rate during massage therapy
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 heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: beats per minute
162.5  (12.7) 169.45  (12.86)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Massage Therapy No Massage Therapy
Hide Arm/Group Description Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours. This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
All-Cause Mortality
Massage Therapy No Massage Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Massage Therapy No Massage Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Massage Therapy No Massage Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
The sample size was small. 30 infants were enrolled, but 7 infants were discharged or became ineligible and could not start the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Richard W Hall MD, Professor of Neonatology
Organization: University of Arkansas for Medical Sciences
Phone: 501-680-7894
EMail: HallRichardW@uams.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01354028     History of Changes
Other Study ID Numbers: 130342
First Submitted: May 12, 2011
First Posted: May 16, 2011
Results First Submitted: January 30, 2013
Results First Posted: June 3, 2013
Last Update Posted: June 3, 2013