Clinical trial NCT05064072: Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation
Official title: The Evaluation of Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: infant
pain
adhesives
fixation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study was planned to evaluate the pain of 4-6 weeks infants felt during removal of the adhesive products from newborn's skin used in the fixation of nasogastric tube in neonatal and infant units. The hypothesis of the study is "Water-based barrier tape is more effective to reduce pain than hydrocolloid barrier tape.

Detailed description: The study was planned as randomized controlled and experimental design to compare the efficiency of three different methods reducing pain during removal adhesive products for 4-6 weeks infants. The universe of the study consisted of 4-6 weeks infants in neonatal and infants clinics of Giresun Women's and Children's Hospital between the dates of July-September 2021. Power analysis was performed through G\*Power (v3.1.7) programme in order to determine the number of the sample. At the beginning of the study, a reference study (Kemer, 2020) was used for sample calculation. The effect size was calculated as d=0.561 regarding the assessment of skin condition scores and 120 participants in total should be included in the study as 40 participants for each groups in order to obtain 80% power in the level of α=0.05. Block randomization technique is applied in the study as a randomization method. "As for data collection "Infant description form" and "Neonatal Infant Pain Scale" was used. The scale was filled by two independent observer via double-blind method.

Eligibility criteria: Inclusion Criteria:

* All the 4-6 weeks infants including interventional process and without any skin diseases

Exclusion Criteria:

* The infants receiving treatment without any interventional process
* Those having a skin disease
* Those infants having peripherally inserted central venous catheter

Primary outcomes:
measure: Water-based barrier tape
timeFrame: 24 hours
measure: Hydrocolloid barrier tape
timeFrame: 24 hours
measure: Silk Tape
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun University Women and Children's Hospital
Study officials:
References:
citation: Field T. Preterm newborn pain research review. Infant Behav Dev. 2017 Nov;49:141-150. doi: 10.1016/j.infbeh.2017.09.002. Epub 2017 Sep 9.
citation: Maxwell LG, Fraga MV, Malavolta CP. Assessment of Pain in the Newborn: An Update. Clin Perinatol. 2019 Dec;46(4):693-707. doi: 10.1016/j.clp.2019.08.005. Epub 2019 Aug 19.
citation: Kemer D, İşler Dalgıç A. Yenidoğanlarda Ağrı Yönetiminde Kullanılan Kanıt Temelli Non-Farmakolojik Hemşirelik Uygulamaları. Balıkesir Sağlık Bilimleri Dergisi. 2020; 9(3):197-204.