The Nonpharmacological Methods in Reducing the Pain Caused by Orogastric Tube Insertion in Preterm Infants

NCT04006743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2019-07-05

No results posted yet for this study

Summary

According to the World Health Organization, preterm birth (from 20 to 37 gestation week) is a significant global health problem, as preterm infants represent an estimated 15 million infants per year worldwide. One of the important problems experienced by the preterm infants, leaving their intrauterine environment earlier than normal, while receiving special treatment and care in Neonatal Intensive Care Unit is the painful procedures. Exposure to pain may change preterm infants' brain structure and organization as well as impair brain development through oxygen desaturation, leading to generation of free radicals that can damage fast-growing tissues. For this reason, preterm infants need to be supported and protected more in pain procedures. Orogastric Tube (OGT) is a feeding method that is used to support the nutrition of preterms that cannot be fed orally and causes OGT insertion pain. Although non-pharmacological methods are effective in reducing the pain caused by OGT insertion in preterms, a limited number of studies have been found. There was no study using combined nonpharmacological methods to reduce OGT insertion pain.To evaluate the efficacy of the use of expressed breast milk, swaddling and facilitated tucking methods alone and combination in reducing the pain caused by OGT insertion in preterms. Randomized controlled trial. Three level III neonatal intensive care units in Turkey. Preterm infants born 32-34 weeks of gestation were randomly assigned to six groups: routine care group (n=33), swaddling group (n=30), facilitated tucking (n=32), expressed breast milk (n=31), swaddling+expressed breast milk group (n=30), and facilitated tucking+expressed breast milk group (n=31). OGT insertion included four phases: baseline (the last 1 min of the 30 min without stimuli), OGT insertion, recovery (1 min after OGT insertion), recovery (2 min after OGT insertion). Four phases of OGT insertion procedures were videotaped. Premature infant pain profile (PIPP) score, heart rate, and oxygen saturation were assessed by two independent evaluators who were blinded to the purpose of the study. Data were analyzed by analysis of variance for the multiple repeated measurements, bonferroni, Generalised Estimating Equation logistic regression. 187 preterm infants completed the protocol.

Conditions

  • Pain
  • Preterm
  • Premature

Interventions

BEHAVIORAL

The swaddling group

The newborns were placed in a supine position on a 90 cm2 soft fabric for swaddling procedure. The upper side of the bandage was aligned with the shoulder of the newborn. Newborns' arms were put in a flexion position. The top of the body was completely covered with a bandage. The infant's head can move freely. The swaddling procedure took about one minute. In the study, swaddling process was applied 10 minutes before the painful procedure. The swaddled newborns remained in the swaddling during the procedure and for 5 minutes after the procedure.

BEHAVIORAL

The expressed breast milk group

In terms of the reliability of the study results, nothing was orally given to the preterm infant at least 30 minutes before the procedure. As recommended in the studies, 2 ml oral breast milk was given to preterm infants before the procedure. In the study, breast milk was given slowly to the upper part of the tongue of each preterm infant from his/her own mother as a single dose before OGT insertion. As a result, preterm was ensured to take all of 2 ml breast milk by reducing the aspiration risk of breastmilk. The breast milk was given without touching the tip of the injector to the newborn's mouth. The preterm infants were not allowed to suck the tip of the injector.

BEHAVIORAL

The facilitated tucking group

Facilitated tucking was given in supine position by holding the arm and legs of the preterm infant to the body by the researcher. In line with the literature, facilitated tucking was initiated 3 minutes before OGT insertion in order for the newborn to feel the fetal position and to cope with the painful procedure. The preterm was kept in fetal position during the procedure and for 5 minutes after the procedure.

BEHAVIORAL

The swaddling and expressed breast milk group

Swaddling procedure was conducted by the researcher to the preterm infant 10 minutes before the OGT insertion procedure. 2 ml breast milk was administered by the researcher to preterm using a sterile injector as a single dose for 2 minutes before OGT insertion procedure. The preterm was remained in swaddling during the OGT insertion procedure and for 5 minutes after the process.

BEHAVIORAL

The facilitated tucking and expressed breast milk group

Facilitated tucking method was applied right after giving 2 ml breast milk by the researcher to the preterm 3 minutes before OGT insertion procedure. Preterm newborn remained in facilitated tucking during the procedure and for 5 minutes after the procedure.

Sponsors & Collaborators

  • Akdeniz University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-15
Primary Completion
2019-01-02
Completion
2019-01-02

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04006743 on ClinicalTrials.gov