Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration

Endotracheal Aspiration Clinical Trial

Official title:

The Effect of Yakson and Gentle Touch Method on Pain, Comfort and Physiological Parameters in Preterm Infants During Endotracheal Aspiration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06308991
• Other study ID #: IDU-SBF-SD-01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2024
• Source: Izmir Democracy University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Weeks to 36 Weeks

Eligibility

Inclusion Criteria:

• Infants in the 26-36/6 gestational week and at appropriate gestational age (AGA)
• Infants undergoing ventilator support with an endotracheal tube

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Endotracheal Aspiration
• Premature Birth

Intervention

Other:
• Yakson touch
Yakson touch method will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.The Yakson method continued for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes).
• Gentle Human Touch
Gentle Human Touch (GHT) method will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.The GHT method continued for 15 minutes.
• Routine care
Infants in the Routine care will be applied swaddling. It will be started 5 minutes before the endotracheal aspiration procedure and continued until the completion of the procedure.

Locations

Country	Name	City	State
Turkey	Izmir Democracy University	Karabaglar	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Democracy University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Pain Agitation and Sedation Scale (N-PASS)	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 Açikgöz 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.	Pain was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Primary	Change in Oxygen saturation	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.	Oxygen saturation was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Primary	Change in Heart rate	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.	Heart rate was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Secondary	COMFORTneo Scale	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.	Comfort was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.