Clinical trial NCT05430100: Reducing Pain During Orogastric Tube Placement in Preterm
Official title: The Effect of usıng Breast mılk pacıfıer, Sucrose pacıfıer and pacıfıer ın reducıng the paın That Occurs durıng orogastrıc Tube ınsertıon ın Preterm Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Pain
Nursing Caries
Keywords: Pain
preterm
orogastric tube
Neonatal Intensive Care Unit
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 73
Sex: ALL
Minimum age (years): 30
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* A gestational age of 30-34 weeks ,
* Having his mother's milk
* Stable state of health
* The fact that the preterm baby has not previously had an orogastic tube inserted
* Having spontaneous breathing
* Being fed through the orogastric tube
* Not taking opioids or non-opioid analgesics
* He did not receive a painful stimulus until 30 minutes before the intervention,
* Volunteer consent of the parents of the preterm neonate to participate in the study

Exclusion Criteria:

* Have any congenital abnormalities on the face or oral cavity,
* The need for a ventilator,
* Having a congenital and genetic anomaly,
* Use of analgesic / Narcotic analgesic drugs,
* The mother has any substance abuse,
* Receiving continuous sedative therapy,
* Congenital malformation that can cause asphyxia and affect breathing
* Preterm newborns with intracranial hemorrhage formed the exclusion criteria of the study.

Primary outcomes:
measure: Premature Infant Pain Profile - PIPP
timeFrame: 1 year
Secondary outcomes:
measure: Heart Rate
timeFrame: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
measure: Oxygen Saturation
timeFrame: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
measure: Cerebral Oxygen Saturation (rScO2)
timeFrame: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
measure: Measurement of incidence of adverse events
timeFrame: 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
city: Ankara
country: Turkey
facility: University of Health Sciences Turkey
Study officials:
affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
name: DİLEK KONUKBAY
role: PRINCIPAL_INVESTIGATOR
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