The Effect of Hydrocolloid Tape and Facial Massage in Premature Infants During Noninvasive Mechanical Ventilation

NCT05844345 | Unknown

• 1 other identifier: KAEK39
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effect of nasal injury prevention interventions (NIPI) (hydrocolloid tape and facial massage) on nasal septum injury, stress and comfort of premature neonates (28-35 weeks gestation) receiving non-invasive mechanical ventilation (NIMV) support.

Conditions

Nasal Injury

Keywords

nasal injury; hydrocolloid tape; non-invasive mechanical ventilation; premature; facial massage; stress; comfort

Outcome Measures

Primary Outcomes (2)

• Nasal Injury Score Table

  The nasal injury score table was developed and was designed with the aim of assessing nasal injury in neonates receiving NIMV support. Pressure injury forming in 6 different anatomical regions of the nose is assessed from 0-4 points and the total points are obtained.

  3 days

• Neonatal Skin Condition Score

  This is a 3-item scale developed to assess the dryness and presence and degree of erythema and disruption/peeling of the skin in preterm, term and post-term infants admitted to the NICU.

  3 days

Secondary Outcomes (2)

• Neonatal Stress Scale

  every 12-hour shift over 3 days for assessment.

• COMFORT scale

  every 12-hour shift over 3 days for assessment.

Study Arms (3)

Hydrocolloid barrier group

EXPERIMENTAL

Premature infants will firstly be assessed by two nurses with undergraduate degrees working in the clinic in terms of neonatal skin condition score, nasal injury score, neonatal stress level and comfort score before beginning NIMV support. The colloid tape will be cut to a t-shape to cover across the bridge of the nose and the nasal septum and philtrum and placed on the infant's face.

Other: Hydrocolloid barrier group

Facial Massage group

EXPERIMENTAL

Premature infants will firstly be assessed by two nurses with undergraduate degrees working in the clinic in terms of neonatal skin condition score, nasal injury score, neonatal stress level and comfort score before beginning NIMV support. After beginning NIMV support, the researcher will perform facial massage 2 times in each 12-hour shift.

Other: Facial Massage group

Control group

NO INTERVENTION

Premature infants will firstly be assessed by two nurses with undergraduate degrees working in the clinic in terms of neonatal skin condition score, nasal injury score, neonatal stress level and comfort score before beginning NIMV support. After beginning NIMV support, no procedure apart from routine care will be performed. Routine care includes feeding every 3 hours, diaper care, position changes, changing the placement of probes and electrodes and confirming the position of the nasal cannula.

Interventions

Hydrocolloid barrier group OTHER

In the hydrocolloid barrier group, Comfeel Plus brand hydrocolloid tape will be used. Hydrocolloid tape is a dressing cover made of soft, flexible and economic material in the form of a semi-permeable film or foam-supported gel. Air exchange continues due to the semipermeable film on the top, while entry of harmful microorganisms to the region is prevented, healing is accelerated by creating a humid environment for the wound and exudate from the wound is absorbed. These features reduce the risk of developing infection and ensure patient comfort. There is no specific change time, though generally the tape is changed every 3-5 days; however, it may remain in place for up to 7 days.

Hydrocolloid barrier group

Facial Massage group OTHER

Premature infants in the facial massage group will have facial massage applied by the researcher. For facial massage, physiological serum used for routine moisturizing in the clinic will be used. When performing facial massage, the fingers will be placed in the middle of the infant's forehead and massage will be performed towards the temples. The eyelids will be lightly rubbed toward the temples. Both thumbs will be placed in the center of the eyebrows and the ridge of the nose will be rubbed toward the lips. The sides of the nose will be rubbed with light pressure. The nasal septum will be rubbed toward the tip of the nose along the philtrum. The fingers will be placed on the philtrum region above the gums and the mouth will be rubbed toward the ears to make a smiling expression. The chin will be lightly massaged toward the back of the ears. The thumbs of both hands will rub from under the infant's chin toward the temples to give make a smiling face (smiling motion).

Facial Massage group

Eligibility Criteria

• Age: 28 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates between 28-34 weeks gestation,
• Preterm neonates beginning nasal NIMV due to respiratory distress within the first six hours after birth,
• Preterm neonates with nasal NIMV after invasive mechanical ventilation,
• Preterm neonates with parental consent to participate in the study.

You may not qualify if:

• Preterm neonates with congenital anomaly (choanal atresia, cleft palate-lip, esophagus atresia, tracheoesophageal fistula, etc.),
• Preterm neonates beginning NIMV support after more than 24 hours,
• Preterm neonates with skin diseases (ichthyosis, etc.),
• Preterm neonates with pulmonary hypertension.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Dilek alemdar

Ordu, 52000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Dilek Küçük Alemdar, PhD

CONTACT

05468435840; dilekkucukalemdar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After the preterm neonates abiding by the inclusion criteria in the research are randomly allocated to the study groups, parents will provide written consent with an informed volunteer consent form without giving parents information about which group their infant will be included in. The researcher will apply the hydrocolloid barrier and facial massage themselves, so the researcher will not be blinded. However, to prevent bias, research outcome measures will be recorded by two nurses who are employed in the NICU, are university graduates and who do not know which infant is in the experiment or control groups. With the aim of preventing bias during analysis of data, the database for the study groups will be coded A, B and C by someone other than the researcher, and analysis of data will be performed by an independent statistical expert. Blinding of outcome measures, statistical analysis and reporting will be performed with the aim of preventing statistical and reporting bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: randomized controlled experimental

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: February 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: May 15, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)