Audio Books Effects on Anxiety and Vital Sings

April 18, 2024 updated by: Esra Oksel, Ege University

Effects of Audio Book Application on Anxiety and Vital Signs With Patients Who Receive NIMV Support

Objectives: This study aimed to investigate the effect of audio book use on anxiety and vital signs in patients receiving non-invasive mechanical ventilation (NIMV) support.

Research Methodology/Design: It is an experimental-randomised controlled study. Settings: The study was carried out with patients hospitalised in the Chest Diseases Intensive Care Unit of a university hospital and NIMV support. The participants consisted of 60 people, 30 in the intervention group and 30 in the control group. Before starting the application in the intervention group, the book preferences of the patients were determined and the selected audio book was played to the patients with headphones via tablet/smartphone. No additional application was made to the control group.

Main Outcome Measures: Anxiety levels and vital signs in the intervention group were evaluated before, 15 minutes, 30 minutes and 30 minutes after the end of the intervention. In the control group, only routine care continued and anxiety levels, and vital signs were assessed simultaneously with the intervention group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Noninvasive mechanical ventilation (NIMV) is a method that provides positive-pressure respiratory support through a mask without the use of an endotracheal tube. In patients in intensive care units, various symptoms such as agitation, anxiety, and disorientation occur due to factors like constant monitoring, limited movement, painful interventions, intensive treatment protocols, and lack of information. Increased anxiety can result in the rejection of NIMV and may lead to unfavorable outcomes, including treatment failure and prolonged hospitalization.

Objectives: It is crucial to manage anxiety and monitor the resulting changes in vital signs in patients receiving NIMV support. In this context, distraction techniques can be employed by nurses to alleviate anxiety and enhance patient compliance with NIMV therapy. This study aimed to investigate the potential of audio books as a distraction technique to reduce anxiety and stabilize vital signs in patients undergoing NIMV support.

Study Design and Setting: The study employed an experimental-randomized controlled design. It was conducted with patients hospitalized in the Chest Diseases Intensive Care Unit of a university hospital who were receiving NIMV support.

Participants: The study sample consisted of 60 patients, with 30 assigned to the intervention group and 30 to the control group. To account for potential losses during the research process, the number of participants was increased by 25% above the minimum required sample size, setting the minimum sample size per group at 30 patients. Participants were numbered sequentially based on their hospital admission.

Intervention: Before initiating the intervention, the audio book preferences of the patients in the intervention group were determined. The selected audio book was played to the patients using headphones through a tablet or smartphone. No additional interventions were applied to the control group, which received only routine care.

Outcome Measures: Anxiety levels and vital signs were assessed at four different time points in the intervention group: before the intervention, 15 minutes, 30 minutes, and 30 minutes after the end of the intervention. In the control group, anxiety levels and vital signs were assessed concurrently with the intervention group.

Data Analysis: The collected data were analyzed using descriptive statistics, including number and percentage distributions. For comparative analyses between groups, the Mann Whitney U Test, Chi-Square Test, Independent Sample t Test, Friedman Test, One-Way Analysis of Variance, Wilcoxon Test, and Bonferroni Posthoc Test were employed.

Study Type

Interventional

Enrollment (Actual)

60

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
    • İzmir
      • Bornova, İzmir, Turkey, 35100
        • Ege University

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

No

Description

Inclusion Criteria:

  • Not having been diagnosed with a neurological disease.
  • At least 6 hours have passed since admission to intensive care
  • Being administered NIMV at least once after admission to intensive care
  • Not having taken any action that would increase anxiety at least 2 hours before the use of NIMV
  • Using an ora-nasal mask
  • Not having been diagnosed with a psychiatric disease
  • Not having sedation treatment
  • Being hemodynamically stable
  • No hearing problems
  • Agreeing to participate in the research

Exclusion Criteria:

  • Refusing to participate in the research
  • Using a full face mask
  • Having deteriorated general condition

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No Intervention
Experimental: Audio Book Application Group
Patients were made to listen to audio books.
Other: Audio Book Application
The Audio Book Application Preference Form asked about book preferences other than horror and thriller genres. The selected audiobook was played with headphones via tablet/smartphone. Separate headphones were used for each patient. Patient Follow-up Form and Facial Anxiety Scale evaluations; the initial measurement (M0) was evaluated before the intervention, the first measurement (M1) at the 15th minute of the intervention, the second measurement (M2) at the 30th minute of the intervention, and the third measurement (M3) 30 minutes after the end of the intervention. Care was taken to ensure that there was no deterioration in the comfort of individuals due to the intervention. In the selection of audio books, language fluency, spelling rules and accessibility were taken into consideration and audiobook platforms to which the researchers were members were used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial Anxiety Scale
Time Frame: before intervention, 15th minute of intervention, 30th minute of intervention 30 minute after intervention
The Facial Anxiety Scale is a measurement tool in which patients self-report their anxiety levels. It consists of five face shapes, the leftmost face expression indicates the absence of anxiety, while the level of anxiety increases towards the right (scored between 1-5). According to the Faces Anxiety Scale, a score of 3 and above by patients indicates that the level of anxiety is at medium and high levels the Faces Anxiety Scale is a valid means of measuring anxiety in intensive care patients.
before intervention, 15th minute of intervention, 30th minute of intervention 30 minute after intervention
Patient Follow-up Form
Time Frame: before intervention, 15th minute of intervention, 30th minute of intervention 30 minute after intervention
It was prepared by the researcher. Haemodynamic parameters including systolic diastolic blood pressure, pulse rate, respiratory rate and oxygen saturation were included.
before intervention, 15th minute of intervention, 30th minute of intervention 30 minute after intervention
Audio Book Application Preference Form
Time Frame: 4 month
It was prepared by the researchers.there are questions about the preferred book, listening time.
4 month
Patient Information Form
Time Frame: 4 month
There are a total of 7 questions in the patient introduction form, including 4 questions on the socio-demographic characteristics of the patients (age, sex, education level, marital status) and 3 questions on the diagnosis of health status (diagnosis of hospitalisation, presence of chronic disease in addition to the diagnosis of hospitalisation, number of days of NIMV connection).
4 month

Collaborators and Investigators

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

Sponsor

Ege University

Investigators

  • Study Director: Esra OKSEL, PhD, Ege University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 15, 2022

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

April 6, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-1T/49

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.

Clinical Trials on Non-invasive Mechanical Ventilation

Clinical Trials on Audio Book Application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe