Clinical trial NCT04678570: Pain Perception Associated With Orogastric Tube Insertion in Preterm Infants
Official title: The Effect of White Noise and Swaddling Methods in Reducing the Pain Caused by Orogastric Tube Insertion in Preterm Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orogastric Tube Insertion
Keywords: Pain
Preterm birth
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This 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.

The study will be conducted between 01/01/2021-15/06/2021 in Usak Öztan Hospital Neonatal Intensive Care Unit.

The sample of the study is planned to have 132 participants with 33 of them in each of the 4 groups.

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.

The interventions that will be used in this study are emphasized in the literature as nonpharmacological methods in reducing and preventing pain.

In Usak Öztan Hospital Neonatal Intensive Care Unit, where the study is planned to be conducted, a pre-application will be performed with 10 preterm infants to evaluate the effect of white noise, swaddling, white noise, and swaddling methods on pain perception in preterm infants with an orogastric tube inserted.

As the video recordings will be used for the evaluation of the pain, the best area for the video recorder to be placed will be decided during this stage.

Insertion of the orogastric tube will be done by the same nurse, who will be briefed about the study concept and will be blinded to the control and the intervention groups, to manage standardization. There will be always a specialist doctor to monitor the infants during this stage for any possible complications.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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,
* With parent not giving consent for the participation of their baby

Primary outcomes:
measure: The Premature Infant Pain Profile-Revised (PIPP-R) Change
timeFrame: 5 minutes, 3 minutes and 1 minute before the procedure. During the procedure. 1 minute, 3 minutes and 5 minutes after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Uşak Öztan Hospital Neonatal Intensive Care Unit
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Öznur GÜRLEK KISACIK, Phd
role: STUDY_DIRECTOR
References: