Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants

February 28, 2024 updated by: Nilay Comuk Balci, Ondokuz Mayıs University

Effects of Kinesio Taping Applications on Diaphragm, Respiratory Muscles and Chest Wall In Very Preterm Infants On Non-invasive Ventilation

This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV. It is hypothesized that the application of kinesio taping to the chest area of preterm infants may improve respiratory functions and oxygenation at the alveolar level, leading to decreased work of breathing, reduced respiratory rate, and improved neonatal stability by promoting respiratory mechanics and enhancing chest expansion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Very preterm infants are at high risk of respiratory distress syndrome (RDS), due to surfactant deficiency and weak respiratory muscles. This condition can contribute to respiratory workload and irregular breathing. This study aimed to investigate the effects of Kinesio kinesio-taping technique on the respiratory muscles and diaphragm in very preterm infants undergoing non-invasive.

Twenty-six preterm infants born before the 32nd gestational week and requiring non-invasive ventilation (NIV) support due to RDS, were randomly divided into 2 groups as Kinesio taping group and control group. Kinesio taping was applied by a single physiotherapist to support the intercostal muscles,and, the diaphragm and facilitatory method was used on the respiratory muscles. Kinesio taping was removed just after preterm infants were weaned from noninvasive ventilation. Blood gas parameters, respiratory rate, heart rate, FiO2, FiO2/pO2 ratio, PIP, PEEP values, and length of stay in NIV were recorded before and after 3 days of KT application.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Atakum
      • Samsun, Atakum, Turkey, 55139
        • Nilay Çömük Balci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preterm infants diagnosed with RDS
  • Preterm Infants born under 32 weeks of gestation

Exclusion Criteria:

  • Sepsis,
  • necrotizing enterocolitis,
  • metabolic disease,
  • severe congenital malformations of the chest and abdominal walls,
  • congenital heart disease,
  • major congenital anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: kinesiotape
Kinesio taping was applied by a single physiotherapist to support the intercostal muscles,and, the diaphragm and facilitatory method was used on the respiratory muscles
Other: kinesiotaping application
kinesiotaping application
No Intervention: Control
This group didn't take kinesiotape application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of pH
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Principal Investigator: Nilay Comuk Balci, Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Estimated)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA18/35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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