Preterm Infants Physiological Parameters and Sleep-Wakefulness Status
Condition: Sleep
Study type: Interventional

Summary: 
      This research was carried out between December 2021 and May 2022 as a randomized controlled
      experimental design. In the study, between 28-35 weeks of gestation preterm infants were
      divided into two groups as the experimental group (n=30) and the control group (n=30). The
      block randomization method was used to ensure that the infants were similar in terms of both
      weeks and weight due to the large interval between the weeks and to ensure the balance
      between the groups. Infants in the control group were followed in the routine prone position
      of the neonatal intensive care unit, while infants in the experimental group were followed in
      the prone position with three-stair positioning pillows.
    

Detailed description: 
      This research was carried a randomized controlled experimental design. The sample size in the
      study was 1.08, type 1 error was 5%, and statistical power was 95%, according to the power
      analysis performed by taking into account the Breathing frequency values of the groups in the
      study called "Effectiveness of Hammock Positioning in Reducing Pain and Improving
      Sleep-Wakefulness State in Preterm Infants". It was calculated as a total of 48 participants,
      24 in each group (Ribas et al., 2019). Considering the possibility of losses, 30 preterm
      infants with TSPP (experimental) and 30 preterm infants who were not used (control) were
      included and the infants were randomly assigned to the groups. The block randomization method
      was used to ensure that the infants were similar in terms of both weeks and weight due to the
      large interval between the weeks and to ensure the balance between the groups. Infants were
      divided into 2 groups as 28-31 week gestation and 32-35 week gestation. 30 infants were
      randomly distributed to each gestational week group as experimental and control groups
      through a program available at http://www.randomizer.org. Families were informed by the
      researcher about the method of the study through face-to-face interviews, written and verbal
      consents were obtained, and the information about preterm infants and their families was
      recorded in the "Information Form". The actigraphy measuring device was connected to the
      computer and the device was installed by entering the parameters such as the name and surname
      of the infant to be treated and the time interval in which the recordings would be made. Data
      were collected from a single hall in the NICU. The noise level of the intensive care unit
      (NICU) was measured with the Uni-T UT353 Mini Decibelmeter Device and the average noise level
      of the hall where the data were collected was between 50-55 dB. The infant was cared for, fed
      and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No
      intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to
      rest. Between these hours, the oxygen saturation and heart rate of the preterm infants in
      both groups were counted by the researcher with a pulse oximeter device and recorded 18 times
      in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the
      Actigraphy measuring device. Preterm infants in the experimental group were followed in the
      prone position with three-stair positioning pillows and the infants in the control group were
      followed in the routine 15º head raised prone position between the hours of the research
      follow-up. The study followed the CONSORT guideline for reporting randomized controlled
      trials.
    

Intervention name(s): Three-stair positioning pillows group
Intervention type(s): Other
Intervention description(s): The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with three-stair positioning pillows. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention