Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration

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

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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Aspiration
• Intervention / Treatment: Other: Yakson touch; Other: Gentle Human Touch; Other: Routine care

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir
    • Karabağlar, Izmir, Turkey, 35140
      • Izmir Democracy University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yakson touch; The Yakson method continued for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In the Yakson touch method, the palms of the practitioner and all fingers were kept in close contact so that the infants did not feel pressure.; Steady touch (5 minutes): One hand rested on the chest and abdomen of the preterm infant, while the other hand supported the back and hip of the preterm infant.; Compassionate Caress (5 minutes): In the same hand position, the practitioner repeated caressing and resting for 5 minutes: Caress (1 minute), rest (30 seconds), caress (1 minute), rest (30 seconds), and caress (2 minutes). The practitioner caressed the infants' chest and belly with a 1 cm diameter clockwise circular movement every 10 seconds.; Steady touch (5 minutes): The practitioner followed the steady touch procedure as previously described.	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).
Experimental: Gentle Human Touch; While the practitioner placed one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was placed on the lower abdomen covering the waist and hip of the infant.	Other: 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.
Other: Routine Care; All infants in the control, Yakson, and GHT groups were applied swaddling as the routine practice of the clinic before and during painful procedures.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	Pain was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Izmir Democracy University
• Investigators: Principal Investigator: Seda Caglar, PhD, Istanbul University - Cerrahpasa (IUC); Principal Investigator: Sadiye Dur, PhD, Izmir Democracy University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Therapeutic Touch; Preterm Infant
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: IDU-SBF-SD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No