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Nasal InjuryNIPINCT05844345

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

A study testing Hydrocolloid barrier group and Facial Massage group in people with Nasal Injury, run by Ordu University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 28 to 35 weeks
Conditions the study is for
Nasal Injury
What is being tested?
Hydrocolloid barrier group and Facial Massage group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2023to 15 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 to 35 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Dilek Küçük Alemdar, PhD contact

05468435840

dilekkucukalemdar@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Dilek alemdar

    Ordu, 52000

    Dilek Küçük Alemdar, dilekkucukalemdar@gmail.com

    Dilek Küçük Alemdar, 05468435840, dilekkucukalemdar@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Hydrocolloid Tape and Facial Massage on Nasal Injury, Comfort and Stress in Premature Infants During Noninvasive Mechanical Ventilation

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.

Read the detailed description

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 receiving non-invasive mechanical ventilation (NIMV) support.

This study is a, prospective randomized controlled trial. The population for the research will comprise 108 premature neonates from 28-35 weeks gestation receiving NIMV support in the neonatal intensive care unit (NICU) from March 2023 to March 2024. Participants will be randomly assigned to one of three groups; the first group (n=40) will have hydrocolloid tape applied, the second group (n=40) will have facial massage and the third group (n=40 will be the control group. Research data will be collected with the Neonatal Descriptive Information Form, Nasal Injury Score Table (NIST), Neonate Skin Condition Scale (NSCS), Premature Infant Comfort Scale (COMFORT) and Neonatal Stress Scale (NSS).

Intervention Tools:

The NICU where the study will be performed uses SLEE 2000 and SLEE 5000 model mechanical ventilators. Both mechanical ventilators have no difference in implementation modes for invasive and non-invasive mechanical ventilation for term and premature infants. All premature infants included in the study will have NIMV support provided using SLEE 2000 and SLEE 5000 model mechanical ventilators. For NIMV of premature infants, NeoSmart brand (Mediplast Respiratory Products Sdn. Bhd, Malaysia) nasal cannulas will be used. The nasal cannula has soft binasal prongs and suitable structure for low- and high-flow oxygen use. A new sterile cannula will be used for each infant. There are 5 different sizes of x small, small, medium, large and x large. The sizes most frequently used for premature infants are small and medium.

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 (Başara, 2022; Ribeiro et al., 2020; Imbulana et al., 2018). 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 (Başara, 2022; Ribeiro et al., 2020; Imbulana et al., 2018; Fletcher et al. 2011; Xie, 2014). 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 (Ribeiro et al., 2020; Fletcher et al. 2011).

Premature infants in the facial massage group will have facial massage applied by the researcher. The researcher has completed 120 hours of theoretical and practical training about infant massage and received the Infant Massage Certificate. 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).

Hydrocolloid barrier group: 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. For 3 days after beginning NIMV support, the same two nurses will assess the neonatal skin condition score, nasal injury score, neonatal stress level and comfort score at 24-hour intervals.

Facial Massage group: 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. For 3 days after beginning NIMV support, the same two nurses will assess the neonatal skin condition score, nasal injury score, neonatal stress level and comfort score at 24-hour intervals.

Control group: 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. For 3 days after beginning NIMV support, the same two nurses will assess the neonatal skin condition score, nasal injury score, neonatal stress level and comfort score at 24-hour intervals. If nasal injury develops in the control group, antibacterial creams may be used in line with permission from the clinical doctor.

Conditions
Nasal Injury
Being tested
Hydrocolloid barrier group, Facial Massage group
Keywords
nasal injury, hydrocolloid tape, non-invasive mechanical ventilation, premature, facial massage, stress, comfort
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydrocolloid barrier groupOther

    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.

  • Facial Massage groupOther

    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).

Study groups in NCT05844345
Study groupRoleWhat they receive
Hydrocolloid barrier groupExperimentalPremature 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.
Receives: Other: Hydrocolloid barrier group
Facial Massage groupExperimentalPremature 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.
Receives: Other: Facial Massage group
Control groupNo interventionPremature 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 days

  2. 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.

    Measured: 3 days

Secondary outcomes (2)
  1. Neonatal Stress Scale

    With the aim of assessing stress in neonates, the validity and reliability for the scale was examined. The scale with 3-point Likert rating comprises a total of 24 items.

    Measured: every 12-hour shift over 3 days for assessment.

  2. COMFORT scale

    Premature infants with gestational age ≥28 and ≤37 weeks. The Turkish validity and reliability of the scale was examined.The scale with 5-point Likert rating assesses 7 parameters of consciousness, calmness/agitation, respiratory status or crying, physical movements, muscle tone, facial movements and mean heart rate. Each item is given points from bad to good of 1 to 5.

    Measured: every 12-hour shift over 3 days for assessment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start15 Feb 2023
  3. Primary completion15 Feb 2024 (estimated)
  4. Study completion15 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled experimental
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05844345
Sponsor's protocol ID
KAEK39
Acronym
NIPI
Status last verified
May 2023
First submitted
25 Apr 2023
Last updated
9 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cengiz D, Kucuk Alemdar D. The effect of hydrocolloid tape and facial massage on nasal injury and stress levels in premature infants on noninvasive mechanical ventilation: Randomized controlled trial. J Tissue Viability. 2025 Feb;34(1):100842. doi: 10.1016/j.jtv.2024.12.006. Epub 2024 Dec 6.

    PubMed 39653601

Questions about this trial

What is this clinical trial studying?

A study testing Hydrocolloid barrier group and Facial Massage group in people with Nasal Injury, run by Ordu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dilek Küçük Alemdar, PhD (05468435840, dilekkucukalemdar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nasal Injury Score Table (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05844345, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

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