An interventional study of Water-based barrier tape and Hydrocolloid barrier tape in Pain, Acute, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 4 Weeks to 6 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by Marmara University · Not applicable, Interventional, and Prevention
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.
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 120 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
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Exclusion Criteria:
The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube
Device: Water-based barrier tape
The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube
Device: Hydrocolloid barrier tape
The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube
Device: Silk tape
The infants in experiment 1 group will be applied water-based barrier tape. The area will be covered by water-based barrier tape to fix nasogastric tube and after waiting 1 minute for drying up it will be fastened by silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the water-based barrier tape, the pain felt by the infants evaluated through "Neonatal Infant Pain Scale" and the score recorded in the chart. This procedure actualized 3 min. before procedure, during and 3 min after procedure.
As for experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube. The hydrocolloid barrier tape, which was cut and shaped appropriately beforehand, will be applied to the area in order to stabilize the nasogastric tube and the tube will be stabilized with silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the hydrocolloid barrier tape, the pain felt by the infants evaluated with "Neonatal Infant Pain Scale" and the score recorded in the chart. Since the hydrocolloid barrier tape can stay on the skin for 7 days and the assessment of the pain realized in 7th day and noted down to the chart. Pain score evaluated in 7th day 3 min. before procedure, during and 3 min after procedure
The silk tape used in clinic routinely will be used for control group infants to fix the nasogastric tube without any barrier. The silk tape will be 5cm long and it will be changed in every 24 hours. Following the removal of silk tape on the silk tape, the pain felt by the infants evaluated through "Neonatal Infant Pain Scale" and the score recorded in the chart. This procedure actualized 3 min. before procedure, during and 3 min after procedure
Water-based barrier tape
To evaluate pain felt by infants following the removal of silk adhesive from water-based barrier tape
Time frame: 24 hours
Hydrocolloid barrier tape
To evaluate pain felt by infants following the removal of silk adhesive from hydrocolloid barrier tape
Time frame: 24 hours
Silk Tape
To evaluate pain felt by infants following the removal of silk adhesive from infants skin without any barrier tape
Time frame: 24 hours
Plan to share: Undecided
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Marmara University