Reducing Pain During Orogastric Tube Placement in Preterm
Condition: Preterm; Pain; Nursing Caries
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The aim of this study is to determine the effectiveness of 3 different methods (breast milk
      pacifier, sucrose pacifier and pacifier) in reducing pain caused by Orogastric Tube (OGT)
      insertion in preterm newborns by monitoring behavioral and physiological changes in infants.
      The study was planned as a randomized controlled experimental study.
    

Detailed description: 
      Babies born before the 37th week of pregnancy are defined as preterm. Preterm newborns need
      Neonatal Intensive Care Unit (NICU) due to their immature characteristics. NICU includes many
      diagnostic and therapeutic procedures associated with pain. Babies are exposed to many
      painful procedures during their stay in the NICU. The International Association for the Study
      of Pain (IASP) defines pain as "an uncomfortable sensory and emotional experience that
      develops as a result of existing or potential tissue damage or is described by this damage".

      It is known that pain begins to be felt by the fetus from the intrauterine second trimester.
      Especially, preterm newborns are more vulnerable to the effects of pain exposure due to their
      developing central and peripheral nervous systems and are more sensitive to pain due to low
      pain thresholds. Therefore, developing appropriate pain control strategies, especially for
      preterm newborns, is both a medical and ethical responsibility. In their study, Zhao et al.
      defined pain as a complex and multidimensional phenomenon experienced in the NICU for preterm
      newborns. In a study by Mooney-Leber et al. with 430 newborns, it was stated that
      approximately 80 painful procedures were performed without specific analgesia. Reducing the
      pain of term and preterm newborns experiencing pain with effective and safe methods is a
      fundamental right of all newborns.

      The sucking reflex in preterm newborns is 28th in intrauterine life. it begins to develop
      after 32-34 weeks of gestation. during the gestational week, sucking and swallowing reflexes
      develop. Preterm newborns admitted to NICU are fed through the orogastric tube (OGT) until
      they can coordinate their sucking, swallowing, and breathing. A probe inserted through the
      mouth into the esophagus (esophagus) and from there into the stomach is called an orogastric
      tube. Measurement of OGT placement in preterm newborns; it is made in such a way that it
      comes from the baby's earlobe to the middle line of the mouth, and from there to the middle
      line between the Deciphoid protrusion and the umbilical cord. Taking the black markers on the
      probe as reference points, the length of the probe is adjusted accordingly, the tip should
      not be touched so that the tip of the probe is not contaminated. The process is stopped when
      the OGT reaches the point measured before the operation. The stomach contents are checked.
      OGT is detected at the edge of the mouth when it is sure of its location.

      The placement and use of OGT is one of the most common nursing practices applied as a
      therapeutic and diagnostic method in NICU . It is used for enteral nutrition, drug
      administration, drainage of the contents of the stomach/small intestine or for decompression
      and gastric analysis in hospitalized infants. However, OGT placement is a painful, stressful
      and troublesome procedure for preterm newborns. In preterm newborns, OGT placement is
      performed frequently until the development of the sucking and swallowing reflex is completed.
      The fact that the pain is felt intensely, the application is frequent, causes more pain in
      preterm newborns. It has been stated that recurrent pain leads to decreased brain
      oxygenation, causing excitotoxic damage to the developing neurons of newborn babies,
      increasing anxiety, changing sensitivity to pain, stress-related diseases, hyperactivity,
      attention deficit and may have negative effects on the development of social abilities.

      Atraumatic care, which is included in nursing approaches, is defined as therapeutic care or
      interventions that eliminate or minimize physical stress factors. In line with atraumatic
      nursing care, pain management is considered as a basic element of care. Newborn nurses
      closely testify to pain and stress. For the prevention of pain, it is important to provide
      individual and holistic nursing care. Accordingly, the knowledge of pharmacological and
      non-pharmacological methods in the management of pain by the nurse has a positive effect on
      the evaluation of pain in infants and pain management. The use of non-pharmacological methods
      that are easy to apply and low in cost by neonatal nurses is important for effective pain
      management. Non-pharmacological methods; sucking, sucrose or dextrose, breastfeeding (breast
      milk), kangaroo care (skin-to-skin contact), wrapping, massage, touching the face,
      positioning (fetal position), acupuncture and music therapy can be listed as non-nutritious
      or nutritious. When the literature is examined, it is stated that it is more effective to use
      more than one non-pharmacological method together in the use of non-pharmacological methods
      instead of their use alone . Given the frequency of OGT administration and the sensitivity of
      preterm infants, ensuring the management of pain during the OGT process will positively
      affect the development of the preterm baby. There are studies in the literature that
      different non-pharmacological methods used in OGT placement are effective in reducing pain in
      preterm newborns. In this study, a study planned in which the methods of using breast milk
      pacifiers, sucrose pacifiers, and pacifiers were compared together to reduce the pain caused
      by orogastric tube insertion in preterm newborns was not found in the literature.

      The use of a pacifier (non-nutritious suction), one of the non-pharmacological methods
      included in the scope of the study, is used in routine practice to improve the ability to
      suck in preterm newborns. To stimulate sucking in non-nutritious sucking, a warning is given
      by touching the cheek, lips, tongue, gums, jaw and palate. The purpose of this method is to
      strengthen sucking by stimulating the oral motor functions of the preterm baby. In this way,
      coordination between sucking, swallowing and during respiration is supported. It is stated
      that sucrose, which will be used as another method, is effective in reducing pain in some
      studies, but there may be problems in terms of cost and access in routine applications.
      Breast milk is a miraculous food that meets all the needs of the newborn in terms of the
      components it contains, and it has the property of preventing the transmission of pain
      sensation by stimulating opioids with the nutrients it contains and blocking the pain fibers.
      It is evaluated that determining the effects on pain management by comparing the pacifier,
      breast milk pacifier and sucrose pacifier methods in reducing the pain that will occur during
      the OGT insertion procedure in preterm newborns, the outcomes will contribute to the
      literature by guiding the effective pain management during the OGT procedure in preterm
      newborns hospitalized in the NICU.

      Hypotheses Of The Study:

      In reducing the pain caused by OGT insertion in preterm infants, Hypothesis 0 (H0): There is
      no difference between breast mılk pacıfıers, sucrose pacıfıers and pacıfıers methods.

      Hypothesis 1.1 (H1.1): The breast mılk pacıfıers method is more effective than the control
      group.

      Hypothesis 1.2 (H1.2): The sucrose pacıfıers method is more effective than the control group.

      Hypothesis 1.3 (h.1.3): The pacifier method is more effective than the control group.

      Hypothesis 1.4 (H1.4): The breast milk pacifier method is more effective than the sucrose
      pacifier group.

      Hypothesis 1.5 (H1.5): The breast milk pacifier method is more effective than the pacifier
      group.

      Hypothesis 1.6 (H1.6): The sucrose pacıfıers method is more effective than breast milk
      pacifier group.

      Hypothesis 1.7 (H1.7): The sucrose pacıfıers method is more effective than pacifier group.

      Hypothesis 1.8 (H1.8): The pacifier method is more effective than the breast milk pacifier
      group.

      Hypothesis 1.9 (H1.9): The pacifier method is more effective than the sucrose pacifier group.

      Place And Tıme Of The Study:

      The study was planned to be carried out after the necessary ethics committee permissions were
      obtained from the Human Research Ethics Committee of Ankara University Faculty of Medicine.
      July 2022- july 2023 will be conducted at Ankara University Neonatal Intensive Care Unit.
      There are 30 nurses in the Neonatal Intensive Care Unit and 4. It serves up to the step.

      Unıverse And Sample Of The Study:

      In the analysis of the research hypotheses, it is planned to perform analyzes of two and more
      than two group comparisons and the highest sample size calculated according to the
      statistical method to be performed is taken as the basis. In this study, "G. Using the
      "Power-3.1.9.2" program, the sample size was calculated to compare multiple 3 or more groups
      at a 95% confidence level. As a result of the analysis, α=0.05, the standardized effect size
      was taken as 0.460461 (high grade) using a similar study conducted in this field earlier, and
      the minimum sample volume was calculated as 56 with a theoretical strength of 0.80.
    

Intervention name(s): The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns; The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns; The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns
Intervention type(s): Other; Other; Other
Intervention description(s): 5 Minutes before the OGT insertion, the camera recording will be started and the preterm newborn will be given a breast milk pacifier. After the breast milk pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's esophagus will be placed by advancing from there to the stomach with the swallowing reflex. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will continue so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement. In terms of the reliability of the research results, nothing should be given orally to a preterm newborn at least 30 minutes before the procedure.; The camera recording will be started 5 minutes before the OGT insertion procedure and the newborn will be given a sucrose-sweetened pacifier. After the sucrose-sweetened pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's esophagus will be placed by advancing from there to the stomach with a swallowing reflex. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will be continued so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement. In terms of the reliability of the research results, nothing should be given orally to a preterm newborn at least 30 minutes before the procedure.; The camera recording will be started 5 minutes before the OGT insertion procedure and the newborn will be given a pacifier. After the pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's swallowing reflex will be placed by moving the esophagus from there to the stomach. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will be continued so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement.
Other intervention name(s): Sucrose Pacifiers Group; Pacifiers Group; Breast Milk Pacifiers Group; Pacifiers Group; Breast Milk Pacifiers Group; Sucrose Pacifiers Group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 4 groups will be involved in our research. These are; - Breast milk pacifiers group, - Sucrose pacifiers group, - Pacifiers group, - Control group. The numbers to be given to the groups will be determined by lot method. In the research, the assignment of the participants to the groups will be made using the "block randomization method". Randomization will be provided by the researcher using microsoft excel. By typing the numbers from 1 to 100 in cell A, adding the RAND() operation to cell B, the number will be generated in all rows from 1 to 100. Then, the sorting process will be performed on the numbers in cell B and a random list will be created in column A. After evaluating the inclusion criteria and obtaining consent from the participants, it will be determined which group the preterm newborn will be in.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pain; preterm; orogastric tube; Neonatal Intensive Care Unit