Evaluation of the Effects of Therapeutic Positioning on Physiological Parameters, Comfort, and Pain Levels in Premature Neonates on Mechanical Ventilation: A Randomized Controlled Study
| Registry | NCT07845435 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 60 (Actual) |
| Sponsor | Mustafa Kemal University (Other) |
| Conditions | Prematurity, Mechanical Ventilation |
| Interventions | Supine Position, Prone Position, Fetal Position (Other) |
| Dates | start 2024-02-07, primary completion 2025-02-07, completion 2025-10-30, first posted 2026-09-28, last updated 2026-09-28 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Prematurity, Mechanical Ventilation All trials of Supine Position All trials of Prone Position
This randomized controlled trial evaluated the effects of three therapeutic positions on physiological parameters, pain, and comfort in mechanically ventilated preterm infants. A total of 60 preterm infants born between 35 and 37 weeks of gestation were randomly assigned to the supine, prone, or fetal position group, with 20 infants in each group. Physiological parameters, pain, and comfort were assessed at baseline, 30 minutes, 2 hours, and 3 hours after positioning. Pain was assessed using the Premature Infant Pain Profile-Revised, and comfort was assessed using the COMFORTneo scale.
Preterm infants receiving mechanical ventilation are exposed to physiological instability, pain, environmental stressors, and reduced comfort during neonatal intensive care. Therapeutic positioning is a non-pharmacological nursing intervention that may support oxygenation, physiological stability, neurobehavioral organization, and comfort.
This three-arm, parallel-group randomized controlled trial was conducted among mechanically ventilated preterm infants born between 35 and 37 weeks of gestation. Infants meeting the eligibility criteria were randomly assigned in a 1:1:1 ratio to the supine position, prone position, or fetal position group. Randomization was performed using a computer-generated random number sequence by an independent researcher.
The assigned position was applied according to a standardized positioning protocol. Ventilator settings were not changed as part of the positioning intervention. Physiological parameters, including heart rate, respiratory rate, peripheral oxygen saturation, and body temperature, were recorded at baseline, 30 minutes, 2 hours, and 3 hours. Pain was assessed using the Premature Infant Pain Profile-Revised, and comfort was assessed using the COMFORTneo scale at the same time points.
The study was designed to determine whether prone and fetal positioning improve physiological stability, reduce pain, and increase comfort compared with routine supine positioning in mechanically ventilated preterm infants.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Supine Position | Experimental | Other: Prone Position; Other: Fetal Position | Infants assigned to the control group were placed in the supine position. The infant was positioned on the back, with the head maintained in the midline, according to the standardized positioning protocol. The position was maintained during the three-hour assessment period. |
| Prone Position | Active comparator | Other: Supine Position; Other: Fetal Position | Infants assigned to this group were placed in the prone position. The trunk and pelvis were supported, and the head was turned slightly to one side according to the standardized positioning protocol. The position was maintained during the three-hour assessment period. |
| Fetal Position | Active comparator | Other: Supine Position | Infants assigned to this group were placed in a flexion-based fetal position. The upper and lower extremities were maintained in flexion, and appropriate positioning supports were used to mimic the intrauterine posture. The position was maintained during the three-hour assessment period. |
Sex: All, ages: 35 Weeks to 37 Weeks
Inclusion Criteria: * Preterm infants born between 35 and 37 weeks of gestation * Receiving invasive or non-invasive mechanical ventilatory support * Clinically stable before positioning * No additional comfort-enhancing intervention administered during the study assessment period * Written informed consent provided by a parent or legal guardian Exclusion Criteria: * Gestational age below 35 weeks or above 37 weeks * Receiving phototherapy during the study assessment period * Presence of a congenital anomaly * Receiving sedative medication * Clinical instability preventing the application of the assigned position
| Facility | City | Country | Status |
|---|---|---|---|
| Çukurova Üniversitesi | Adana | Turkey (Türkiye) |