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NCT Number: NCT05064072

Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation

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.

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Key information

Conditions

Pain, Acute Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 week–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Giresun University Women and Children's Hospital

Giresun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water-based barrier tape

Device

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.

Hydrocolloid barrier tape

Device

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

Silk tape

Device

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

Primary outcomes

  1. Water-based barrier tape

    Time frame: 24 hours

    To evaluate pain felt by infants following the removal of silk adhesive from water-based barrier tape

  2. Hydrocolloid barrier tape

    Time frame: 24 hours

    To evaluate pain felt by infants following the removal of silk adhesive from hydrocolloid barrier tape

  3. Silk Tape

    Time frame: 24 hours

    To evaluate pain felt by infants following the removal of silk adhesive from infants skin without any barrier tape

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Evaluation of Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation: Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2021
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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