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

NCT04006743 | Completed

• 1 other identifier: TDK-2018-3032
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pain; preterm; premature; orogastric tube; newborn nurse

Outcome Measures

Primary Outcomes (1)

• Premature Infant Pain Profile (PIPP)

  The Premature Infant Pain Profile (PIPP) scale was used for the pain assessment. The primary outcome was the pain score assessed with PIPP scale, a validated and widely used tool to measure procedural pain in preterm infants; It measures pain according to two contextual indicators (gestational age and behavioral state), two physiological indicators (heart rate and oxygen saturation), and three behavioral indicators (brow bulge, eye squeeze, and nasolabial furrow). PIPP scores ≥ 6 are suggested to indicate at least mild pain, and scores ≥ 12 are suggested to indicate moderate-to-severe pain.

  1 year

Secondary Outcomes (3)

• Heart Rate

  1 year

• Oxygen Saturation

  1 year

• Measurement of incidence of adverse events

  1 year

Study Arms (6)

The routine care group

NO INTERVENTION

In the routine care group, while a neonatal nurse performed the OGT insertion procedure, physiological measurements of the highest value of heart rate and the lowest value of oxygen saturation were recorded by one researcher (the first author) 1 min before the procedure, during the process and after the process in 1st and 2nd minutes acquired for each infant in the unit with an individual monitor.

The swaddling group

EXPERIMENTAL

In this group, preterm infants were given swaddling method.

Behavioral: The swaddling group

The expressed breast milk group

EXPERIMENTAL

In this group, preterm infants were given expressed breast milk method.

Behavioral: The expressed breast milk group

The facilitated tucking group

EXPERIMENTAL

In this group, preterm infants were given facilitated tucking method.

Behavioral: The facilitated tucking group

The swaddling and expressed breast milk group

EXPERIMENTAL

In this group, preterm infants were given combined swaddling and expressed breast milk method.

Behavioral: The swaddling and expressed breast milk group

The facilitated tucking and expressed breast milk group

EXPERIMENTAL

In this group, preterm infants were given combined facilitated tucking and expressed breast milk method.

Behavioral: The facilitated tucking and expressed breast milk group

Interventions

The swaddling group BEHAVIORAL

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.

The swaddling group

The expressed breast milk group BEHAVIORAL

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.

The expressed breast milk group

The facilitated tucking group BEHAVIORAL

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.

The facilitated tucking group

The swaddling and expressed breast milk group BEHAVIORAL

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.

The swaddling and expressed breast milk group

The facilitated tucking and expressed breast milk group BEHAVIORAL

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.

The facilitated tucking and expressed breast milk group

Eligibility Criteria

• Age: 32 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• gestational age (GA) between 32 and 34 weeks at delivery
• postnatal age between 3 and 28 days
• being fed with OGT
• not scheduled to receive sedatives, muscle relaxants, or analgesic drugs 24 h before a study session
• having spontaneous breathing
• having breast milk. In this study, GA was defined as the time (in weeks) from the first day of the last menstrual period to date of birth.

You may not qualify if:

• history of surgery
• congenital or known genetic anomalies
• disorders affecting brain circulation or cardiovascular system
• severe medical conditions requiring treatment such as sedatives, muscle relaxants, anti-epileptic, or analgesic drugs
• in the condition of fasting
• mother with a history of substance-abuse.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Premature Birth

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessment of the videos was blinded. PIPP score was measured by two specialist pain doctors who were blinded to the study purpose, and to the study group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Model Details: This study was randomized controlled trial on the effects of combined and alone use of swaddling, expressed breast milk, and facilitated tucking on preterm infants before, during and after OGT insertion procedure. Preterm infants were randomly allocated before the OGT insertion by a neonatal nurse using a random closed envelope manner to one of the six groups: routine care group, swaddling, expressed breast milk, facilitated tucking, swaddling+expressed breast milk, and facilitated tucking+expressed breast milk group. After obtaining parental written consent, neonatal nurse who apply OGT insertion randomized the infant and learned the allocation group. The nurses could not be blinded to the allocation because of the nature of the intervention. However, nurses were blinded to the study hypotheses. Additionally, the outcome assessment of the videos was blinded.

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: June 15, 2017
• Primary Completion: January 2, 2019
• Study Completion: January 2, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)