Clinical trial NCT06308991: Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration
Official title: The Effect of Yakson and Gentle Touch Method on Pain, Comfort and Physiological Parameters in Preterm Infants During Endotracheal Aspiration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Aspiration
Keywords: Therapeutic Touch
Pain
Preterm Infant
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 26
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The order of the 2 different touching methods and routine care practices to be applied to the infants in the research group was determined by randomized method and 3 groups were created. Considering the order of application in each group, it was decided which touch method and routine care would be applied to the infants. Both touch techniques and routine care practices were applied once to each infant.

Group 1: Yakson touch, Routine care, Gentle HumanTouch Group 2: Routine care, Gentle HumanTouch, Yakson touch Group 3: Gentle HumanTouch, Yakson touch, Routine care
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal Pain Agitation and Sedation Scale (N-PASS)
timeFrame: Pain was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
measure: Change in Oxygen saturation
timeFrame: Oxygen saturation was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
measure: Change in Heart rate
timeFrame: Heart rate was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Secondary outcomes:
measure: COMFORTneo Scale
timeFrame: Comfort was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
Other outcomes:
Locations:
city: Karabağlar
country: Turkey
facility: Izmir Democracy University
state: Izmir
Study officials:
affiliation: Izmir Democracy University
name: Sadiye Dur, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Seda Caglar, PhD
role: PRINCIPAL_INVESTIGATOR
References: