NCT06944093

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

March 11, 2025

Last Update Submit

April 17, 2025

Conditions

Respiratory Failure With Hypercapnia

Outcome Measures

Primary Outcomes (4)

  • Agitation Scores

    10 month

  • Breathing Rate

    10 month

  • Breathing Depth

    10 month

  • SpO₂ Levels

    10 month

Study Arms (2)

Experimental

EXPERIMENTAL

Listen to a audio book

Behavioral: audio book

Control

NO INTERVENTION

Interventions

audio bookBEHAVIORAL

Listen to a audio book

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients unwilling to participate or wishing to withdraw from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Faculty of Nursing

Erzurum, Erzurum, 25000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2025

First Posted

April 25, 2025

Study Start

May 1, 2024

Primary Completion

September 1, 2024

Study Completion

March 1, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Locations

TU(1)