Pain Clinical Trial
Official title:
The Effect of usıng Breast mılk pacıfıer, Sucrose pacıfıer and pacıfıer ın reducıng the paın That Occurs durıng orogastrıc Tube ınsertıon ın Preterm Newborns
Verified date | August 2023 |
Source | Saglik Bilimleri Universitesi Gulhane Tip Fakultesi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to determine the effectiveness of 3 different methods (breast milk pacifier, sucrose pacifier and pacifier) in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. The study was planned as a randomized controlled experimental study.
Status | Completed |
Enrollment | 73 |
Est. completion date | May 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Weeks to 34 Weeks |
Eligibility | Inclusion Criteria: - A gestational age of 30-34 weeks , - Having his mother's milk - Stable state of health - The fact that the preterm baby has not previously had an orogastic tube inserted - Having spontaneous breathing - Being fed through the orogastric tube - Not taking opioids or non-opioid analgesics - He did not receive a painful stimulus until 30 minutes before the intervention, - Volunteer consent of the parents of the preterm neonate to participate in the study Exclusion Criteria: - Have any congenital abnormalities on the face or oral cavity, - The need for a ventilator, - Having a congenital and genetic anomaly, - Use of analgesic / Narcotic analgesic drugs, - The mother has any substance abuse, - Receiving continuous sedative therapy, - Congenital malformation that can cause asphyxia and affect breathing - Preterm newborns with intracranial hemorrhage formed the exclusion criteria of the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara University | Ankara | |
Turkey | University of Health Sciences Turkey | Ankara |
Lead Sponsor | Collaborator |
---|---|
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi |
Turkey,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Premature Infant Pain Profile - PIPP | PIPP assesses pain with seven indicators. These are three behavioral (forehead wrinkles, enlargement of the eye wings and nose), two physiological (heart rate and oxygen saturation) and two contextual (gestational week and sleep/wake state) variables. The PIPP scale has 7 items to assess the baby's pain, such as gestational week, behavioral status, highest heart rate, lowest oxygen saturation value, forehead wrinkles, squint eyes, and enlarged nasal wings. Each item; It is scored from good to bad as 0, 1, 2, and 3. Premature Baby Pain Profile Scale is evaluated as mild pain between 0-6 points, moderate pain between 7-12 points and severe pain between 13-21 points. | 1 year | |
Secondary | Heart Rate | The number of heartbeats per minute was obtained using an electrocardiographic bedside monitor and continuously recorded by custom computer software. An electrocardiographic bedside monitor was inserted into each of the infants. | 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure | |
Secondary | Oxygen Saturation | Oxygen saturation (SpO2) was obtained using an electrocardiographic bedside monitor and continuously recorded by custom computer software. A separate an electrocardiographic bedside monitor was inserted into each of the infants. | 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure | |
Secondary | Cerebral Oxygen Saturation (rScO2) | Cerebral Oxygen Saturation (rScO2) was obtained using an electrocardiographic bedside monitor and continuously recorded by custom computer software. A separate an electrocardiographic bedside monitor was inserted into each of the infants. | 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure | |
Secondary | Measurement of incidence of adverse events | The safety of different interventions (Breast milk pacifier, Sucrose pacifier and Pacifier) was assessed by the incidence of adverse events during the study period. The adverse events included: apnea, aspiration, cyanosis, tachycardia, bradycardia, tachypnea, dyspnea. The adverse events were monitored and recorded by specialist neonatal doctor who were blind to the purpose of the study. In case of a side effect, it was planned for the specialist neonatal doctor to stop the intervention immediately and to intervene. | 1 minute before the procedure. During the procedure. 1 minute and 2 minutes after the procedure |
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