Effects of Massage Therapy to Induce Sleep in Preterm Infants

NCT01354028 | Completed Results DMC

• 1 other identifier: 130342
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Birth of Newborn

Keywords

premature infant; massage therapy; sleep induction; relaxation

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Minute massage ended

Secondary Outcomes (2)

• Oxygen Saturation Levels During Massage

  During massage

• Heart Rate

  During massage therapy

Study Arms (2)

Massage therapy

EXPERIMENTAL

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

No massage therapy

NO INTERVENTION

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.

Interventions

Massage therapy OTHER

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.

Massage therapy

Eligibility Criteria

• Age: 3 Days - 20 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \> 3 days old
• weeks adjusted gestational age
• Minimum of 28 weeks gestational age at birth
• Clinically stable as determined by an neonatologist
• Stable respiratory status on room air or nasal cannula flow \<2 LPM

You may not qualify if:

• Clinically unstable and/or unable to be moved from the infant warmer
• Severe congenital anomalies likely to be associated with developmental delay
• Apgar score of ≤ 3 at 5 minutes of age
• Any other condition that in the opinion of the investigator might result in unnecessary or excessive risk to the subject
• Unstable respiratory status
• Sedation in the previous 24 hours before the infant's trial.
• Neurological disease: grade III or IV intraventricular hemorrhage, periventricular leukomalacia, evidence of hypoxic ischemic encephalopathy
• Anticipated painful procedures during the study period between 9 am and 12 pm

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Massage

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Limitations and Caveats

The sample size was small. 30 infants were enrolled, but 7 infants were discharged or became ineligible and could not start the study.

Results Point of Contact

• Title: Dr Richard W Hall MD, Professor of Neonatology
• Organization: University of Arkansas for Medical Sciences

HallRichardW@uams.edu

501-680-7894

Study Officials

• Richard W Hall, M.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 16, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 3, 2013
• Results First Posted: June 3, 2013

Record last verified: 2013-04

Locations

US (1)