Pain Perception Associated With Orogastric Tube Insertion in Preterm Infants

NCT04678570 | Unknown

• 1 other identifier: 2020-467
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled experimental study designed to examine the effect of white noise and swaddling methods in reducing the pain caused by orogastric tube insertion in preterm infants. This study is planned to be conducted with 4 groups, consisting of 3 experimental groups and 1 control group. White noise, swaddling method, and white noise + swaddling methods will be the interventions during the study together with the standard care and procedures for the experimental groups, while the control group will only have standard care and procedures during the study.

Conditions

Orogastric Tube Insertion

Keywords

Pain; Preterm birth

Outcome Measures

Primary Outcomes (1)

• The Premature Infant Pain Profile-Revised (PIPP-R) Change

  The PIPP-R scale includes 3 behavioral (brow bulge, eye squeeze, nasolabial-furrow), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral state and gestational age) items. Each item has a score from 0-3. The highest score that can be obtained from the PIPP-R scale for preterm infants is 21.The mean scores obtained from the PIPP-R scale reflects mild level of pain as mild if it is between 0-6 points, moderate if it is between 7-12 points and severe if it is between 13-21 points.

  5 minutes, 3 minutes and 1 minute before the procedure. During the procedure. 1 minute, 3 minutes and 5 minutes after the procedure

Study Arms (4)

Intervention Group-1

EXPERIMENTAL

White Noise intervention and standard care, procedures will be applied.

Other: White Noise

Intervention Group- 2

EXPERIMENTAL

The swaddling method and standard care, procedures will be applied.

Other: Swaddling Method

Intervention Group- 3

EXPERIMENTAL

White Noise, swaddling method, and standard care, procedures will be applied.

Other: White Noise; Other: Swaddling Method

No Intervention Group

NO INTERVENTION

Standard care and procedures to be applied.

Interventions

White Noise OTHER

The infants will be listened to a song Called " Bebeginiz Aglamasin" from Orhan Osman's colic album which was prepared with the help of Dr. Harvery Karp's ''The Happiest Baby'' album through a portable speaker located at 50 cm away from the infant at 55-decibel frequency. Listening to this song will start 5 minutes before the insertion of the Orogastric Tube, will continue during the procedure and another 5 more minutes after the procedure is completed. The rest of the noise in the environment will be controlled.

Intervention Group- 3; Intervention Group-1

Swaddling Method OTHER

The preterm infants will be placed in the supine position on a 90 cm2 soft cloth. The upper edge of the cloth will be aligned with the infant's shoulder, with the arms placed close to the body, with the horizontal ends of the cloth folded in the opposite direction to cover the top of the body. The arms will be put into flexion and the body will be covered with a cloth. In order not to limit the movements of all limbs of the preterm infant, attention will be paid to leave a finger space between the infant and the cloth cover and to leave a suitable space for the feet to be comfortable before folding the lower part of the cloth cover forward. In the swaddling method, the baby's head can move freely. The swaddling method will be applied approximately 5-10 minutes before the procedure and will be removed from the infant 5 minutes after the procedure. Because swaddling will increase the body temperature of the infant, the standard temperature of the incubator will be lowered.

Intervention Group- 2; Intervention Group- 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• With 32-34 weeks of gestation,
• With the postnatal age between 3-28 days,
• Birth weight is above 1000 grams,
• With the Apgar score ≥7 at 1st and 5th minutes,
• With stable vital signs,
• Without any congenital anomaly,
• Not receiving mechanical ventilator support and having spontaneous breathing,
• Requested by the physician to place an orogastric tube and fed with an orogastric tube,
• Breastfeeding (through an orogastric tube),
• Not experienced a painful procedure at least half an hour before the interventions,
• Without the use of opioid or non-opioid analgesic in their treatment,
• Without congenital or acquired malformation related to hearing,
• With parents written consent for the participation of their baby.

You may not qualify if:

• With the postnatal age outside 3-28 days,
• Birth weight is ≤ 1000 grams,
• With the Apgar score \<7 at 1st and 5th minutes,
• With unstable vital signs,
• With congenital anomaly in the face or the oral cavity,
• Being on mechanical ventilator support,
• With a congenital malformation that may affect respiration and cause asphyxia,
• With intracranial bleeding or risk of bleeding,
• With disorders affecting the cerebral circulation or cardiovascular system,
• Subjected to a painful procedure at least half an hour before the interventions,
• With opioid or non-opioid analgesic in their treatment,
• With the surgical history,
• With continuous sedative treatment,
• With congenital or acquired malformation related to hearing,
• Not being fed with an orogastric tube,

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Uşak Öztan Hospital Neonatal Intensive Care Unit

Uşak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Premature Birth

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

Study Officials

• Öznur GÜRLEK KISACIK, Phd

  Afyonkarahisar Health Sciences University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The same nurse, who will perform the insertion of the orogastric tube, will be blinded to the control and the intervention groups. Another nurse, who will take the measurements of the heart rate and the saturation, will be blinded to the control and the intervention groups. 2 observers, independent from the study, who will assess the pain will be blinded to the intervention and control groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor PhD

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Study Start: January 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: October 15, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)