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NCT01354028 · ClinicalTrials.gov registry record · NA
Effects of Massage Therapy to Induce Sleep in Preterm Infants
A NA study, sponsored by University of Arkansas.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01354028: Completed NA study, sponsored by University of Arkansas.
NCT01354028 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01354028, a NA study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- OTHER Massage therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-06 |
| Phase | NA |
What the finished NCT01354028 record still lists
NCT01354028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Massage therapy is the first listed.
NCT01354028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01354028 about?
NCT01354028 is a clinical study titled "Effects of Massage Therapy to Induce Sleep in Preterm Infants". 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 sta...
What is the current status of trial NCT01354028?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2011-03. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01354028?
The interventions under investigation include: Massage therapy (OTHER).
Who is sponsoring clinical trial NCT01354028?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01354028's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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