Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration
- Conditions
- Endotracheal Aspiration
- Registration Number
- NCT06308991
- Lead Sponsor
- Izmir Democracy University
- Brief Summary
The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.
- Detailed Description
Background: Preterm infants in the neonatal intensive care unit are exposed to various painful procedures, so different non-pharmacological pain control techniques are used to alleviate pain.
Aims: To determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.
Design: A randomized controlled crossover trial. Setting: This study was conducted in the neonatal intensive care unit between July 2022 and June 2023.
Methods: Thirty neonates were enrolled in this study based on inclusion criteria. The samples were randomly received a sequence of suctioning with Yakson and GHT and routine care. Neonatal Pain Agitation and Sedation Scale and COMFORT neo were used to collect the data.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Infants in the 26-36/6 gestational week and at appropriate gestational age (AGA)
- Infants undergoing ventilator support with an endotracheal tube
- Infants taking opiates and sedatives within four hours, having undergone a painful procedure at least one hour before
- Infants congenital anomalies, sepsis or haemorrhagic disease that might prevent Yakson and GHT
- Infants who underwent surgery and had a chest tube
- Infants with intracranial hemorrhage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change in Heart rate Heart rate was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure. Heart rate of infants before, during, and after endotracheal aspiration were recorded to a computer using a Masimo Radical 7 Pulse Oximeter at 2-second intervals.
Neonatal Pain Agitation and Sedation Scale (N-PASS) Pain was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure. Pain will be evaluated using the Neonatal Pain Agitation and Sedation Scale (N-PASS).This scale was developed by Hummel Puchalski in 2000 for preterm and term babies. The Turkish validity and reliability study was conducted by Açıkgöz et al. in 2017. Crying, irritability, behavior-state, facial expression, extremity tone, and vital signs parameters are evaluated in the N-PASS scale. In this scale is evaluated with triple likert type and pain score can be between "0" and "10". Permission was obtained from the authors to use the scale.
Change in Oxygen saturation Oxygen saturation was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure. Oxygen saturation of infants before, during, and after endotracheal aspiration were recorded to a computer using a Masimo Radical 7 Pulse Oximeter at 2-second intervals.
- Secondary Outcome Measures
Name Time Method COMFORTneo Scale Comfort was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure. This scale was developed by Van Dijk et al. in 2009 for preterm babies. The Turkish validity and reliability study was conducted by Kahraman et al. in 2014. It is a 5-point Likert type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. The lowest score that can be obtained from the scale is 6 and the highest score is 30. It is emphasized that if the total score of the scale is between 9-13, the baby is comfortable, if it is between 14-30, the baby is in pain or distress, the baby is uncomfortable and needs interventions to provide comfort.
Trial Locations
- Locations (1)
Izmir Democracy University
🇹🇷Karabağlar, Izmir, Turkey
Izmir Democracy University🇹🇷Karabağlar, Izmir, Turkey