Clinical trial NCT06306794: Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration
Official title: The Effect of Crochet Octopus Use on Pain and Comfort in Endotracheal Aspiration of the Premature Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Premature Baby 26 to 32 Weeks
Premature Baby 33 to 36 Weeks
Aspiration
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration.

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.


Eligibility criteria: Inclusion Criteria:

* Gestational age range of 26-36 weeks
* 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:

* Receiving analgesic medication
* Major congenital anomaly
* Having a pneumothorax tube
* Stage III and intraparenchymal hemorrhage
* Receiving a sedative medication

Primary outcomes:
measure: pain in the during endotracheal aspiration
timeFrame: 5 minutes
Secondary outcomes:
measure: comfort in the during endotracheal aspiration
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References: