Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration

NCT06306794 | Not Yet Recruiting

• 1 other identifier: 2011-KAEK-25 2023/12-26
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Premature Baby 26 to 32 Weeks; Premature Baby 33 to 36 Weeks; Aspiration

Outcome Measures

Primary Outcomes (1)

• pain in the during endotracheal aspiration

  To decrease the Premature Infant Pain Scale-Revise score of the experimental group compared to the control group. Items in the PIPP-R scale include three behavioral (frowning, squinting eyes, prominence of the nasolobial groove), two physiological (heart rate and oxygen saturation) and two contextual (behavioral status and gestational age) items. According to the scale, the highest score is 21 for premature babies and 18 for term newborns. According to the scale scoring, scoring between 0 and 6 indicates that the premature baby has mild pain, between 7 and 12 points indicates that the premature baby has moderate pain, and between 13 and 21 points indicates that the premature baby has severe pain.

  5 minutes

Secondary Outcomes (1)

• comfort in the during endotracheal aspiration

  5 minutes

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Other: crochet octopus

control group

NO INTERVENTION

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.

Interventions

crochet octopus OTHER

During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure.

experimental group

Eligibility Criteria

• Age: 1 Day - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nurgül Tekin: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nurgül TEKIN

CONTACT

0224 295 50 00; nurgulkrtls@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Msc

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share