Pain Perception Associated With Orogastric Tube Insertion in Preterm Infants
NCT ID: NCT04678570
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
132 participants
INTERVENTIONAL
2021-01-01
2022-10-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
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.
Study Groups
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Intervention Group-1
White Noise intervention and standard care, procedures will be applied.
White Noise
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- 2
The swaddling method and standard care, procedures will be applied.
Swaddling Method
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- 3
White Noise, swaddling method, and standard care, procedures will be applied.
White Noise
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.
Swaddling Method
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.
No Intervention Group
Standard care and procedures to be applied.
No interventions assigned to this group
Interventions
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White Noise
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.
Swaddling Method
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Afyonkarahisar Health Sciences University
OTHER
Responsible Party
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ÖZNUR GÜRLEK KISACIK
Assistant Professor PhD
Principal Investigators
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Öznur GÜRLEK KISACIK, Phd
Role: STUDY_DIRECTOR
Afyonkarahisar Health Sciences University
Locations
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Uşak Öztan Hospital Neonatal Intensive Care Unit
Uşak, , Turkey (Türkiye)
Countries
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Other Identifiers
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2020-467
Identifier Type: -
Identifier Source: org_study_id
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