The Effect of Touch Methods on Pain and Physiological Parameters in Preterm Infants During Endotracheal Aspiration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-37
SponsorAcibadem University
About this trial
Recurrent and painful interventions such as heel lancing, venipuncture, dressing change, endotracheal aspiration are frequently performed in neonatal intensive care units (NICU). Touch is one of the infant's earliest developing senses. Therefore it is very important among individualized supportive care practices. Correct stimulation of the infant's sense of touch affects psychosocial development positively. In addition, it is reported that touch has a calming and analgesic effect during invasive interventions. Therefore, there is a need for touch appropriate for development of newborn.
The aim of this study was determine the effect of Yakson and Gentle Human Touch on pain and physiologic parameters in preterm infants during endotracheal aspiration.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The gestational week of the infant is less than 38
Absence of congenital anomaly
Mechanical ventilator support
Absence of comorbid disease
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Touch Methods
Other interventionThe Yakson touch method continue for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In this method, the palms of the practitioner and all fingers keep in close contact so that the babies don't feel pressure. Gentle human touch refers to steady contact of the skin without caressing or massaging. While the practitioner place one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was place on the lower abdomen covering the waist and hip of the infants.
Treatment groups
81 Participants
are divided into 1 treatment groupGroup A: No Intervention and Touch GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pain Score
Pain will be evaluated using the Neonatal Pain Agitation and Sedation Scale (N-PASS).This scale was developed for preterm and term babies. The Turkish validity and reliability study was conducted 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.
Time frame
Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.2
Change in Oxygen saturation
Oxygen saturation will be evaluated using the pulse oximeter
Time frame
Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.3
Change in Heart rate
Heart rate will be evaluated using the monitor
Time frame
Data will be collected from 5 minutes before the aspiration up to the 15th minute. Change in this time intervals will be assessed during 15 minutes.Sponsors and contacts
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Source ClinicalTrials.gov