The Nonpharmacological Methods in Reducing the Pain Caused by Orogastric Tube Insertion in Preterm Infants
Condition: Pain; Preterm; Premature
MeSH terms: Premature Birth
Study type: Interventional

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.
    

Detailed description: 
      Orogastric tube feeding is a feeding method used to support the feeding of newborns who
      cannot be fed orally and OGT insertion causes pain. Ottawa Neonatal Pain Interest Group
      (2015) and the studies have shown that OGT insertion causes acute pain in newborns. It was
      stated that OGT insertion causes pain in newborns and non-pharmacological methods were
      effective in reducing this pain. However, there have been no studies in which
      non-pharmacological methods (expressed breast milk, swaddling and facilitated tucking
      methods) are alone and in combination with OGT insertion procedural pain for preterm infants.
      Therefore, the purpose of this study is to evaluate the efficacy of using expressed breast
      milk, swaddling and facilitated tucking methods together and alone in reducing the pain
      caused by OGT insertion process in preterm infants. Based on the above literature review and
      mechanisms, the investigators hypothesized that: (1) Swaddling, expressed breast milk, and
      facilitated tucking alone could be more effective than routine care on preterm infant pain
      before, during, and after OGT insertion procedure. (2) Pain occur less frequently before,
      during, and after OGT insertion procedure in preterm infants treated with combinations of
      swaddling, expressed breast milk, and facilitated tucking than in those receiving routine
      care. (3) Combined intervention of swaddling+expressed breast milk, and facilitated
      tucking+expressed breast milk could be more effective than any single intervention on preterm
      infant pain before, during, and after OGT insertion procedure.

      Preterm infants were recruited by convenience sampling from level III neonatal intensive care
      units of three hospitals in Turkey/Antalya from November 2017 to 2018. Preterm infants
      meeting study criteria (n=219) from 2017 to 2018. Participation was refused by 24 parents who
      did not want their infants to be videotaped data collection (12), refused anything extra done
      to their infants (n=10), were not interested (n=2) and 8 infants did not need OGT insertion;
      thus, 187 infants participated in this study. Preterm infants who did participate did not
      differ significantly in terms of sex, GA, postnatal age, and body weight. To calculate study
      power, the investigators first determined that the effect size was 0.51, based on the mean
      Premature Infant Pain Profile (PIPP) scores, respectively, and the correlation (r=0.385) of
      PIPP scores between the six groups. Based on this effect size and a significance level of
      0.05, the study power (two tailed) with 187 infants was 0.99. Based on the between- and
      within-group variances of PIPP scores during OGT insertion procedures the effect size was
      0.33. Thus, a sample size of 187 preterm infants was sufficient. 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, the outcome
      assessment of the videos was blinded. OGT insertion procedure was conducted by the clinical
      nurse in NICU within the scope of treatment for preterm infants in the case when clinical
      physician was deemed as necessary. The assigned treatment condition was administered by one
      researcher. 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 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. In the swaddling group, 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. 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. In the expressed breast milk group, 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. In the facilitated tucking group,
      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. In the combined
      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. In the combined 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. The
      Premature Infant Pain Profile (PIPP) scale was used for the pain assessment. Physiological
      indicators were continuously monitored and behavioral indicators (facial images) were
      videotaped by a real-time colour video recorder. The digital camera was fixed at a certain
      angle via the tripod 30 minutes before the procedure. Pain was scored from videotapes of
      infants' faces 10 min before, 2 min during, and 5 min after OGT insertion procedures. PIPP
      score was measured by two specialist pain doctors who were blinded to the study purpose, and
      to the study group allocation. The inter-rater reliability of the Premature Infant Pain
      Profile ranged from 0.97-0.99 (0.97 for baseline [phase 1], 0.97 phase 2, 0.98 phase 3, 0.99
      phase 4, respectively). All preterm infants, heart rate and oxygen saturation were measured
      using an electrocardiographic bedside monitor and continuously recorded by custom computer
      software.

      Each OGT insertion included four phases: (1) Baseline: 1 min of baseline was collected at the
      end of the 30 min without stimuli. (2) OGT insertion: conducting the OGT measurement,
      inserting and fixing OGT (3) Recovery: one min after OGT insertion. (4) Recovery: two min
      after OGT insertion. Heart rate, oxygen saturation, and PIPP scores were evaluated by four
      phases.

      For the statistical analysis of the data obtained in the study, SPSS (Statistical Package for
      Social Science) for Windows 22.0 and SAS software, version 9.4 (SAS Institute Inc., Cary, NC,
      USA) packaged software were used. In the analysis of the measurements such as heart rate and
      oxygen saturation taken from the same newborns at different times, both graphical methods and
      repeated measures analysis of variance were used. Paired-sample t-test was applied to the
      features found to be significant as a result of repeated measures analysis of variance.
      Advanced analysis of the Bonferroni post-hoc test was also performed. Concordance between the
      two first evaluators for the PIPP measurements were evaluated using the intraclass
      correlation coefficient (ICC).

      In order to compare the preterm infants with and without pain in six different application
      groups, those having PIPP values of ≥6 were defined as 1 "pain" and values less than 6 were
      defined as 0 "no pain". In the analysis of the repeated measure data obtained from the
      preterm infants in six application groups and at different measurement times, the Generalized
      Estimating Equation (GEE) method's multiple logistic regression models were used. When the
      observations are related with each other as in the data with repeated measures, GEE models
      give more effective and unbiased estimates than ANOVA-based models. Statistical significance
      was defined as p<0.05.
    

Intervention name(s): The swaddling group; The expressed breast milk group; The facilitated tucking group; The swaddling and expressed breast milk group; The facilitated tucking and expressed breast milk group
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pain; preterm; premature; orogastric tube; newborn nurse