- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06944093
Listen to a Audio Book
April 17, 2025 updated by: Burak YAVUZ, Ataturk University
Noninvasive Mechanical Ventilation is Applied to Patients With Hypercapnic Respiratory Failure on the Agitation Scores and Respiratory Parameters
This study investigates how listening to audiobooks affects agitation scores and respiratory parameters (like breathing rate, depth, and oxygen saturation) in patients receiving non-invasive mechanical ventilation (NIMV) for hypercapnic respiratory failure in an intensive care unit.
Participants will listen to an audiobook of their choice during their 2-hour NIMV treatment.
Their agitation levels and respiratory parameters will be measured before, during, and after NIMV application.
The goal is to evaluate whether audiobooks can reduce patient agitation and improve respiratory outcomes, offering a low-cost, easy-to-use, and effective approach for better patient care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
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
-
-
-
Erzurum, Turkey, 25000
- Ataturk University Faculty of Nursing
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Patients aged 18 years or older Patients hospitalized in the Chest Diseases Intensive Care Unit Diagnosed with Hypercapnic Respiratory Failure Undergoing Non-invasive Mechanical Ventilation (NIMV) No hearing impairment Conscious and alert patients
Exclusion Criteria:
Patients unwilling to participate or wishing to withdraw from the study
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Experimental
Listen to a audio book
|
Listen to a audio book
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Agitation Scores
Time Frame: 10 month
|
10 month
|
|
Breathing Rate
Time Frame: 10 month
|
10 month
|
|
Breathing Depth
Time Frame: 10 month
|
10 month
|
|
SpO₂ Levels
Time Frame: 10 month
|
10 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2024
Primary Completion (Actual)
September 1, 2024
Study Completion (Actual)
March 1, 2025
Study Registration Dates
First Submitted
March 11, 2025
First Submitted That Met QC Criteria
April 17, 2025
First Posted (Actual)
April 25, 2025
Study Record Updates
Last Update Posted (Actual)
April 25, 2025
Last Update Submitted That Met QC Criteria
April 17, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ATA.0.01.00/169
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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