Pain and Comfort Level During Orogastric Catheter Insertion in Preterms

NCT06222047 | Completed DMC

• 1 other identifier: buchOG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the research: This research was planned to evaluate the effect of breast milk and dextrose application, which are pain relief methods, on the pain and comfort levels of preterm babies who will have an orogastric tube inserted in the 3rd and 4th levels of the Neonatal Intensive Care Unit. Hypotheses: H0: The methods used during orogastric tube insertion do not affect the pain and comfort levels of preterm babies. H1: Preterm babies who are breastfed feel less pain during orogastric tube insertion. H2: Preterm babies given dextrose during orogastric tube insertion feel less pain. H3: The comfort level of preterm babies who are breastfed during orogastric tube insertion is higher. H4: The comfort level of preterm babies given dextrose during orogastric tube insertion is higher. H5: There is a difference between the pain and comfort levels of preterm patients in terms of group, time, and group-time, depending on the intervention applied.

Conditions

Prematurity; Pain Acute; Comfort; Orogastric Tube Insertion

Outcome Measures

Primary Outcomes (2)

• OG catheter-related pain

  Neonatal Infant Pain Scale (NIPS): The Newborn Infant Pain Scale (NIPS) was developed by Lawrence et al. in 1993. Turkish validity and reliability were established by Akdovan in 1999. Reliability values were found to be 0.83, 0.83, and 0.86 before, during, and after the procedure, respectively. The newborn infant pain scale is a Likert-type scale consisting of 6 parameters, facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; groaning, 2; loud crying), breathing (0; comfortable, 1; variable-irregular), arm (0: relaxed-free, 1; flexion-extension), leg (0; comfortable-free, 1; flexion-extension) and sleep-wake (0; sleeping-waking peaceful, 1; restless).

  2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion

• OG catheter-related comfort

  The Newborn Comfort Behavior Scale: The newborn comfort behavior scale is a Likert-type scale developed to evaluate the comfort needs, pain, and distress of newborn babies. This scale was developed by Ambuel et al. (1992) to evaluate the comfort, pain, and stress status of newborn babies receiving mechanical ventilator support in the intensive care unit. This scale consists of six parameters: alertness, agitation, respiratory response/crying, body movements, facial tension, and muscle tone. Each item on the scale is scored between 1-5. If the total score obtained as a result of the evaluation is below 13, it is emphasized that the baby is comfortable, if it is 14 and above, the baby's comfort level is low, and additional interventions to increase comfort may be required.

  2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion

Study Arms (3)

Breast milk

EXPERIMENTAL

Breast Milk Intervention: Wrapping was applied to the baby as a standard approach. 2 minutes before the insertion of the oragastric catheter, 2 ml of breast milk was given to the babys mouth with a syringe. After the baby was given breast milk, video recording started. The steps for inserting an orogastric catheter were followed, and the baby was monitored in an incubator during the application, with pulse and saturation monitored.

Other: breast milk

Dextrose

EXPERIMENTAL

Dextrose Intervention: The baby will receive wrapping as standard treatment. The orogastric catheter is visible to the brim with 2 ml of 20% dextrose syringe 2 minutes before the insertion chamber (Bueno et al., 2013). After the baby is given dextrose, the video recording will start. The steps of the orogastric tube insertion procedure will be followed. The baby will be in an incubator during the application, with pulse and saturation monitored.

Other: dextrose

Control group

NO INTERVENTION

The control group: Baby will be wrapped as standard treatment. Video recording will start 2 minutes before the baby is inserted into the orogastric catheter. The steps of the orogastric tube insertion procedure will be followed. The baby will be in an incubator during the application, with pulse and saturation monitored. No additional intervention will be applied to the baby.

Interventions

breast milk OTHER

give breast milk before the OG catheter insertion

Breast milk

dextrose OTHER

give %20 dextrose before the OG catheter insertion

Dextrose

Eligibility Criteria

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

You may qualify if:

• Birth week 32-34,
• Postnatal week has reached 32-34 weeks,
• Birth weight over 1500 grams,
• whose general condition is stable,
• Planned to insert an orogastric tube,
• Developed sucking and swallowing reflexes, being able to hold a pacifier,
• Having breast milk,
• Preterms whose parents agreed to participate in the study were included in the study.

You may not qualify if:

• In need of oxygen support,
• Receiving analgesic and/or sedation treatment,
• In the preoperative and/or postoperative period,
• Those with congenital anomalies of the mouth and palate,
• Those with metabolic (e.g. NEC) and genetic (e.g. osteogenesis imperfecta) diseases,
• Painful intervention was performed at least 30 minutes before the procedure, Preterm babies will be excluded from the research.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, 35000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Acute Pain

Interventions

Milk, Human; Glucose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Sevgi Güven

  Dokuz Eylul University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Breast milk and dextrose video recording It was applied just before starting. It is not clear which intervention was made before the procedure.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof., RN

Model Details: Breast Milk Dextrose Control

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: March 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)