Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration
NCT ID: NCT06306794
Last Updated: 2024-03-12
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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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2024-04-01
2025-04-01
Brief Summary
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It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups.
PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse.
During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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experimental group
During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study.
crochet octopus
During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure.
control group
The routine aspiration application steps of the unit will be applied to the control group without any intervention. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study.
No interventions assigned to this group
Interventions
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crochet octopus
During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure.
Eligibility Criteria
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Inclusion Criteria
* The baby should be between postnatal day 0 and 5 (Postnatal day of baby should be between 0 and 5 days.)
* Need for invasive mechanical ventilator support
* Need for endotracheal aspiration
* No analgesic, opioid and sedative medication was applied within the 4 hours before the endotracheal aspiration
* At least 2 hours passed since the last painful procedure
Exclusion Criteria
* Major congenital anomaly
* Having a pneumothorax tube
* Stage III and intraparenchymal hemorrhage
* Receiving a sedative medication
1 Day
5 Days
ALL
No
Sponsors
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Nurgül Tekin
OTHER
Responsible Party
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Nurgül Tekin
Msc
Central Contacts
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Other Identifiers
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2011-KAEK-25 2023/12-26
Identifier Type: -
Identifier Source: org_study_id
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