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

Marmara University

Status: Completed

Conditions: Pain, Acute

Treatments: Device: Hydrocolloid barrier tape; Device: Water-based barrier tape; Device: Silk tape

Study type: Interventional

Funder types: Other

Identifiers

NCT05064072

23618724

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 4 to 6 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Water-based barrier tape

Experimental group

Description:

The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube

Treatment:

Device: Water-based barrier tape

Hydrocolloid barrier tape

Experimental group

Description:

The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube

Treatment:

Device: Hydrocolloid barrier tape

Silk plaster

Active Comparator group

Description:

The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube

Treatment:

Device: Silk tape