Comparison of Two Methods in Pain Caused by Orogastric Tube Placement in Preterm Newborns

NCT06438731 | Recruiting

• 1 other identifier: AIBU-SBF-MG-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Aim : This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm newborns. Method : This study was planned as a randomized controlled trial. The study group will consist of 66 preterms with a gestational age of 32-34 weeks fed by orogastric tube. Informed Consent Form, Preterm Newborn Introduction Form, Physiologic Parameters Measurement Form and Premature Infant Pain Profile (PIPP) will be used in the study. The research will be conducted in the Neonatal Intensive Care Unit of a university hospital in Denizli province. Newborns in the breast milk group will be given oral breast milk before the procedure. Newborns in the knitted octopus group will be provided with the octopus touching various parts of their bodies as a tactile stimulation before the procedure. No intervention will be performed on newborns in the control group. Data will be obtained by the researcher from camera recording and patient file. In evaluating the data, continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Parametric and non-parametric tests will be used to examine the differences between groups. Hypothesis: It is expected to contribute to the development of a new approach in the pain management of preterm newborns by evaluating the effectiveness of breast milk and knitted octopus in reducing the pain caused by orogastric tube insertion in preterm newborns.

Conditions

Pain

Keywords

Pain; Knitted Octopus; Orogastric Tube; Breast Milk; Preterm

Outcome Measures

Primary Outcomes (1)

• Premature Infant Pain Profile (PIPP)

  In order to evaluate the baby's pain, the PIPP scale questions 7 items such as gestational age, behavioral status, highest heart rate value, lowest oxygen saturation value, forehead wrinkling, squinting of the eyes and widening of the nose wings. Each item; It is scored as 0, 1, 2 and 3, from best to worst. According to the Premature Baby Pain Profile, the baby's pain is evaluated based on the total score. Accordingly, the highest is 21 points and the lowest is 0 points. If the Premature Baby Pain Profile is between 0 and 6 points, the pain is considered mild, between 7 and 12 points, it is considered moderate, and between 13 and 21 points, the pain is considered severe.

  one year

Study Arms (3)

Breast Milk Group

ACTIVE COMPARATOR

Preterm newborns in this group will be administered their own mother's milk with a sterile syringe as 1 ml single dose 2 minutes before orogastric tube insertion. During administration, the baby will not be allowed to suck the tip of the syringe and breast milk will be dripped onto the tongue. Nothing oral will be given 30 minutes before the procedure.

Other: BREAST MILK

Knitted Octopus Group

ACTIVE COMPARATOR

The knitted octopus method will be applied to preterm newborns in this group before orogastric tube insertion. The arms of the knitted octopus will wrap around the baby's arms and legs, and its head will be on the baby's body.

Other: KNITTED OCTOPUS

Control Group

NO INTERVENTION

For preterm newborns in this group, no method will be applied before orogastric tube insertion and routine procedures will be performed.

Interventions

BREAST MILK OTHER

The preterm will be monitored for 5 minutes before birth, during the procedure cycle, and then by camera recording for 5 minutes

Breast Milk Group

KNITTED OCTOPUS OTHER

The preterm will be monitored for 5 minutes before birth, during the procedure cycle, and then by camera recording for 5 minutes

Knitted Octopus Group

Eligibility Criteria

• Age: 32 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational week between 32-34 weeks
• Postnatal age ≤ 37 weeks
• Having breast milk
• Weighing 1000 grams or more
• Spontaneous breathing
• Being fed with an orogastric tube
• Not being exposed to a painful procedure at least half an hour before the interventions
• Parental consent for the newborn to participate in the study

You may not qualify if:

• Having received ventilator support (may have received it before)
• Any congenital anomaly of the face or oral cavity
• Grade 3 and 4 intraventricular hemorrhage
• Taking opioid or non-opioid analgesics
• Repeated orogastric tube placement

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Hospital

Denizli, Pamukkale, 20160, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Akkaya-Gul A, Ozyazicioglu N. Effect of pacifier and pacifier with dextrose in reducing pain during orogastric tube insertion in newborns: a randomized controlled trial. J Perinatol. 2024 May;44(5):717-723. doi: 10.1038/s41372-024-01948-w. Epub 2024 Mar 29.

  PMID: 38553602 BACKGROUND

• Sener Taplak A, Erdem E. A Comparison of Breast Milk and Sucrose in Reducing Neonatal Pain During Eye Exam for Retinopathy of Prematurity. Breastfeed Med. 2017 Jun;12:305-310. doi: 10.1089/bfm.2016.0122. Epub 2017 Apr 17.

  PMID: 28414522 BACKGROUND

• Srivastava G, Garg A, Chhavi N, Faridi M. Effect of kangaroo mother care on pain during orogastric tube insertion in low-birthweight newborns: An open label, randomised trial. J Paediatr Child Health. 2022 Dec;58(12):2248-2253. doi: 10.1111/jpc.16212. Epub 2022 Sep 21.

  PMID: 36131630 BACKGROUND

• Bueno M. Combined non-pharmacological interventions minimise pain during orogastric tube insertion in preterm neonates. Evid Based Nurs. 2020 Aug 12:ebnurs-2020-103267. doi: 10.1136/ebnurs-2020-103267. Online ahead of print. No abstract available.

  PMID: 32796001 BACKGROUND

• Calik C, Esenay F. The clinical effect of pacifier use on orogastric tube-fed preterm infants: A randomized controlled trial. J Pak Med Assoc. 2019 Jun;69(6):771-776.

  PMID: 31189280 BACKGROUND

Related Links

• THE EFFECT OF BREAST MILKING, WRAPPING AND FETAL POSITIONING METHODS IN REDUCING THE PAIN DUE TO OROGASTRIC TUBE INSERTION IN PRETERM NEWBORN.
• Effect of Mothers' Heartbeats Combined with Swaddling Technique on Orogastric Tube Insertion Pain among Preterm Neonates
• Crochet octopuses help soothe premature babies in Araçatuba
• Use of crochet octopus for premature babies in the neonatal unit: an electronic news analysis

MeSH Terms

Conditions

Pain; Premature Birth

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Melek Nur GÜZEL

  BAĞLANTISIZ

  PRINCIPAL INVESTIGATOR

• Sebahat ALTUNDAĞ

  BAĞLANTISIZ

  STUDY DIRECTOR

Central Study Contacts

Melek Nur GÜZEL

CONTACT

5346247995; makyol162@posta.pau.edu.tr

Sebahat ALTUNDAĞ

CONTACT

saltundag@pau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinding (participants) will be used in the study. Participants will not be informed about which group they are in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Model Details: Breast Mılk, Knıtted Octopus And Control Group

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: March 29, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)