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Audio Books Effects on Anxiety and Vital Sings

E

Ege University

Status

Completed

Conditions

Non-invasive Mechanical Ventilation

Treatments

Other: Audio Book Application

Study type

Interventional

Funder types

Other

Identifiers

NCT06378970
22-1T/49

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Audio Book Application Group
Experimental group
Description:
Patients were made to listen to audio books.
Treatment:
Other: Audio Book Application
Control Group
No Intervention group
Description:
No Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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