Reducing Pain During Orogastric Tube Placement in Preterm

NCT05430100 | Completed

• 1 other identifier: SBU-KONUKBAY-002
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm; Pain; Nursing Caries

Keywords

Pain; preterm; orogastric tube; Neonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Premature Infant Pain Profile - PIPP

  PIPP assesses pain with seven indicators. These are three behavioral (forehead wrinkles, enlargement of the eye wings and nose), two physiological (heart rate and oxygen saturation) and two contextual (gestational week and sleep/wake state) variables. The PIPP scale has 7 items to assess the baby's pain, such as gestational week, behavioral status, highest heart rate, lowest oxygen saturation value, forehead wrinkles, squint eyes, and enlarged nasal wings. Each item; It is scored from good to bad as 0, 1, 2, and 3. Premature Baby Pain Profile Scale is evaluated as mild pain between 0-6 points, moderate pain between 7-12 points and severe pain between 13-21 points.

  1 year

Secondary Outcomes (4)

• Heart Rate

  1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure

• Oxygen Saturation

  1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure

• Cerebral Oxygen Saturation (rScO2)

  1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure

• Measurement of incidence of adverse events

  1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure

Study Arms (4)

Breast Milk Pacifiers Group

EXPERIMENTAL

To determine the effectiveness of breast milk pacifier in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants.

Other: The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns

Sucrose Pacifiers Group

EXPERIMENTAL

To determine the effectiveness of sucrose pacifier in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants.

Other: The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns

Pacifiers Group

EXPERIMENTAL

To determine the effectiveness of pacifier in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants.

Other: The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns

Control Group

NO INTERVENTION

The camera recording will be started 5 minutes before the OGT insertion procedure and the routine OGT placement process will be performed. No pain-related procedures are performed during routine OGT in the NICU.

Interventions

The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns OTHER

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.

Also known as: Sucrose Pacifiers Group, Pacifiers Group

Breast Milk Pacifiers Group

The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns OTHER

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.

Also known as: Breast Milk Pacifiers Group, Pacifiers Group

Sucrose Pacifiers Group

The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns OTHER

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.

Also known as: Breast Milk Pacifiers Group, Sucrose Pacifiers Group

Pacifiers Group

Eligibility Criteria

• Age: 30 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (2)

Ankara University

Ankara, Turkey (Türkiye)

Location

University of Health Sciences Turkey

Ankara, Turkey (Türkiye)

Location

Related Publications (19)

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• Chen S, Zhang Q, Xie RH, Wen SW, Harrison D. What is the Best Pain Management During Gastric Tube Insertion for Infants Aged 0-12months: A Systematic Review. J Pediatr Nurs. 2017 May-Jun;34:78-83. doi: 10.1016/j.pedn.2016.12.015. Epub 2016 Dec 24.

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• Celik F, Sen S, Karayagiz Muslu G. Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants: A Randomized Controlled Trial. Clin Nurs Res. 2022 Jun;31(5):891-900. doi: 10.1177/10547738211058312. Epub 2021 Nov 16.

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• Fitri SYR, Lusmilasari L, Juffrie M, Bellieni CV. Modified Sensory Stimulation Using Breastmilk for Reducing Pain Intensity in Neonates in Indonesia: A Randomized Controlled Trial. J Pediatr Nurs. 2020 Jul-Aug;53:e199-e203. doi: 10.1016/j.pedn.2020.04.004. Epub 2020 May 10.

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• Ganguly A, Bhadesia PJ, Phatak AG, Nimbalkar AS, Nimbalkar SM. Pain profile of premature infants during routine procedures in neonatal intensive care: An observational study. J Family Med Prim Care. 2020 Mar 26;9(3):1517-1521. doi: 10.4103/jfmpc.jfmpc_1033_19. eCollection 2020 Mar.

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• Hoarau K, Payet ML, Zamidio L, Bonsante F, Iacobelli S. "Holding-Cuddling" and Sucrose for Pain Relief During Venepuncture in Newborn Infants: A Randomized, Controlled Trial (CASA). Front Pediatr. 2021 Jan 14;8:607900. doi: 10.3389/fped.2020.607900. eCollection 2020.

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• Li L, Wang L, Niu C, Liu C, Lv T, Ji F, Yu L, Yan W, Dou YL, Wang Y, Cao Y, Huang G, Hu X. Early skin contact combined with mother's breastfeeding to shorten the process of premature infants </= 30 weeks of gestation to achieve full oral feeding: the study protocol of a randomized controlled trial. Trials. 2021 Sep 17;22(1):637. doi: 10.1186/s13063-021-05605-x.

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• Lin T, Hu J, Zhang L, Qin X, Liu X, Lan Y, Chen K, You T. Promoting enteral tube feeding safety and performance in preterm infants: A systematic review. Int J Nurs Stud. 2022 Apr;128:104188. doi: 10.1016/j.ijnurstu.2022.104188. Epub 2022 Feb 4.

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• Mala O, Forster EM, Kain VJ. Neonatal Nurse and Midwife Competence Regarding Pain Management in Neonates: A Systematic Review. Adv Neonatal Care. 2022 Apr 1;22(2):E34-E42. doi: 10.1097/ANC.0000000000000911. Epub 2021 Jul 1.

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• Mooney-Leber SM, Brummelte S. Neonatal pain and reduced maternal care alter adult behavior and hypothalamic-pituitary-adrenal axis reactivity in a sex-specific manner. Dev Psychobiol. 2020 Jul;62(5):631-643. doi: 10.1002/dev.21941. Epub 2019 Dec 1.

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MeSH Terms

Conditions

Premature Birth; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• DİLEK KONUKBAY

  Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 24, 2022
• Study Start: July 10, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)