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

NCT05064072 | Completed

• 1 other identifier: 23618724
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Keywords

infant; pain; adhesives; fixation

Outcome Measures

Primary Outcomes (3)

• Water-based barrier tape

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

  24 hours

• Hydrocolloid barrier tape

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

  24 hours

• Silk Tape

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

  24 hours

Study Arms (3)

Water-based barrier tape

EXPERIMENTAL

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

Hydrocolloid barrier tape

EXPERIMENTAL

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

Device: Hydrocolloid barrier tape

Silk plaster

ACTIVE COMPARATOR

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

Device: Silk tape

Interventions

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.

Water-based barrier tape

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

Hydrocolloid barrier tape

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

Silk plaster

Eligibility Criteria

• Age: 4 Weeks - 6 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Giresun University Women and Children's Hospital

Giresun, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28898671 RESULT

• 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.

  PMID: 31653303 RESULT

• Kemer D, İşler Dalgıç A. Yenidoğanlarda Ağrı Yönetiminde Kullanılan Kanıt Temelli Non-Farmakolojik Hemşirelik Uygulamaları. Balıkesir Sağlık Bilimleri Dergisi. 2020; 9(3):197-204.

  RESULT

MeSH Terms

Conditions

Acute Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 1, 2021
• Study Start: July 1, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

TU (1)