Reducing Pain During Orogastric Tube Insertion in Newborns: Use of Pacifiers and Pacifiers Sweetened With 25% Dextrose
Condition: Pain
Study type: Interventional

Summary: 
      Orogastric tube(OGT) placement, which is used for monitoring, diagnostic and therapeutic
      purposes, causes pain and stress in premature and term newborns. Non-pharmacological pain
      intervention with pacifiers and sweetener solutions (sucrose, dextrose, etc.) in newborns is
      a viable nursing approach to reduce pain. In the limited number of studies in the literature,
      it was seen that pacifiers and sucrose were used in nasogastric tube(NGT) applications and
      they were especially focused on premature babies. In our study, due to the fact that it was
      conducted in term newborns and, unlike the limited number of studies, OGT was placed in the
      stomach in the form of a pacifier and a 25% dextrose pacifier leaking from the rim. Our study
      was conducted as a randomized controlled experimental study to examine the effect of using
      pacifiers and dextrose pacifiers on pain reduction during orogastric tube placement, and also
      to evaluate the effects on behavioral response and physiological parameters (heart rate,
      oxygen saturation) in newborns.In addition, it was thought that the fact that the study was
      carried out by passing a pacifier and a pacifier sweetened with 25% dextrose, would
      facilitate progress and reduce trauma by stimulating the swallowing reflex in newborns via a
      pacifier as in adults.The population of the study consisted of term newborns at 38-42 weeks
      of gestation who were hospitalized in the Neonatal Intensive Care Unit of a hospital in
      Turkey between April-December 2019. The sample group randomly consisted of 60 newborns
      (Control group: 20, Intervention group with only pacifiers:20, with dextrose flavored
      pacifiers:20). 20 babies in the intervention group were given only pacifiers and 20 babies
      were given a pacifiers flavored with dextrose 2 minutes before the OGT insertion. The
      procedure was performed by leaking the tube from the edge of the pacifiers. Routine OGT
      insertion was performed in the control group. The data collection process was recorded with a
      camera. The Neonatal Infant Pain Scale (NIPS), the highest heart rate and lowest oxygen
      saturation from physiological pain responses, and crying time from behavioral parameters were
      evaluated by the researcher by watching the camera recording. Variance analysis, Shapiro
      Wilk, Kruskal Wallis, Chi-square, Bonferro, and Wilcoxon tests were used in the statistical
      analysis of the study. The SPSS v22 package program was used for statistical analysis and the
      significance level was taken at α=0.05.
    

Detailed description: 
      Painful and invasive procedures for follow-up, diagnostic and therapeutic purposes are an
      inevitable part of care in the neonatal intensive care unit. Effective pain management is at
      the core of nursing care and is based on a comprehensive assessment of the infant and its
      pain. Nurses and the interdisciplinary healthcare team have a responsibility to prevent or
      minimize pain during these procedures. Studies to reduce pain during OGT insertion were
      generally performed in premature newborns, but there are few studies performed in term
      newborns. It has been observed that there are not enough studies on OGT that focus on NGT
      placement in the studies. In the studies examined, the use of dextrose and pacifier alone,
      which are non-pharmacological methods in reducing pain, were generally discussed, and no
      studies involving the combined use were found. It is thought that our study will be useful in
      terms of the fact that feeding tube placement, which is known to be a painful and stressful
      procedure, will be performed in term newborns, presenting new evidence to nurses for reducing
      pain and stress, and supporting the existing study results.

      This study is a randomized controlled experimental study to examine the effect of using
      pacifiers and dextrose pacifiers on pain reduction during orogastric tube placement in
      newborns, as well as to evaluate behavioral responses and physiological changes in newborns.
      In addition, it was thought that the fact that the study was carried out by passing a
      pacifier and a pacifier sweetened with 25% dextrose, would facilitate progress and reduce
      trauma by stimulating the swallowing reflex in newborns via a pacifier as in adults. Ethical
      approval was obtained from the Bursa Uludağ University Faculty of Medicine Clinical Research
      Ethics Committee before starting the study. In order to start the research after the approval
      of the ethics committee, T.C. Permissions were obtained from the Istanbul Provincial Health
      Directorate and the Istanbul Tuzla State Hospital management. In addition, written consent
      was obtained from the families of the newborns in the control and intervention groups, with
      an informed consent form. The research was carried out in Turkey/Istanbul Tuzla State
      Hospital neonatal intensive care unit between April-December 2019. The population consisted
      of term newborns who were hospitalized in the neonatal intensive care unit of Istanbul Tuzla
      State Hospital, whose OGT placement procedure was deemed clinically appropriate, and legal
      permission was obtained from their families. Of these newborns, a total of 60 newborns, 20+20
      in the intervention group and 20 in the control group, were included in the sample group. The
      first intervention group consisted of 20 newborns given a pacifier alone, the second
      intervention group consisted of 20 newborns given a pacifier sweetened with 25% dextrose, and
      20 newborns in the control group. Randomization was provided by the researcher for babies who
      met the inclusion criteria of the study during weekday neonatal intensive care unit working
      hours. For this; During working hours, the first newborn to be fitted with OGT was in the
      control group, the second newborn was given a pacifier only, and the third newborn was in the
      pacifier intervention group sweetened with 25% dextrose. When there was not enough OGT
      indication (less than 3) on the same day, the application continued in the same order in the
      next clinical shift. It was applied in the same way for each group before the procedure.
      Information about the baby and the mother in the baby and mother introduction form, which was
      prepared by using the literature, was filled in before the procedure. The newborns were
      placed under a radiant warmer in an open bed 5 minutes before the procedure. In newborns who
      could not be placed under a radiant heater, the application was performed in an incubator.
      After the preparation of the necessary materials before the application, the OGT measurement
      to be placed was made and the marking process was carried out. A saturation probe was placed
      in the baby to monitor heart rate and oxygen saturation. The newborn was prepared for the
      procedure by adjusting the camera monitor focused on the baby's face in the field of view. 2
      minutes before OGT insertion, 20 babies in the intervention groups were given pacifiers
      alone, and 20 babies were given pacifiers sweetened with 25% dextrose. The procedure was
      carried out by leaking the tube from the pacifiers. In the control group, routine OGT
      placement was performed without giving anything. The data collection process was recorded
      with a camera. After the evaluation period was completed and the baby was comfortable, the
      recording was stopped. However, the recording continued without any time constraint to
      monitor the crying time of the baby who continued to cry during the insertion. The dependent
      variables of the study were the score from the NIPS pain scale, oxygen saturation, heart
      rate, and crying time.
    

Intervention name(s): Pacifiers Group (İntervention Group 1); Pacifier group sweetened with 25% dextrose (İntervention Group 2)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Camera recording was started 2 minutes before OGT placement and only a pacifier was given to the newborn. After the pacifier in the OGT intervention group was placed in the mouth of the given baby in the form of leaking from the mouth, it was inserted by advancing the baby's swallowing reflex from the esophagus to the stomach. It was checked whether the orogastric tube was in the right place. After the evaluation period was completed and the baby was comfortable, the recording was stopped.; Camera recording was started 2 minutes before OGT insertion and the newborn was given a pacifier sweetened with 25% dextrose. After the dextrose-sweetened pacifier in the OGT intervention group was placed in the mouth of the baby in the form of a leak from the mouth, it was inserted by advancing the baby's esophagus and then to the stomach with the swallowing reflex of the baby. It was checked whether the orogastric tube was in the right place. After the evaluation period was completed and the baby was comfortable, the registration was stopped.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Neonatal; Orogastric tube; Pacifiers; %25 Dextrose; NIPS