Audio Books Effects on Anxiety and Vital Sings

NCT06378970 | Completed

• 1 other identifier: 22-1T/49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-invasive Mechanical Ventilation

Keywords

respiration support; anxiety; vital signs; audio book

Outcome Measures

Primary Outcomes (4)

• Facial Anxiety Scale

  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

  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

  It was prepared by the researchers.there are questions about the preferred book, listening time.

  4 month

• Patient Information Form

  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

Study Arms (2)

Audio Book Application Group

EXPERIMENTAL

Patients were made to listen to audio books.

Other: Audio Book Application

Control Group

NO INTERVENTION

No Intervention

Interventions

Audio Book Application OTHER

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.

Audio Book Application Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Related Publications (3)

• McKinley S, Coote K, Stein-Parbury J. Development and testing of a Faces Scale for the assessment of anxiety in critically ill patients. J Adv Nurs. 2003 Jan;41(1):73-9. doi: 10.1046/j.1365-2648.2003.02508.x.

  PMID: 12519290 BACKGROUND

• McKinley S, Stein-Parbury J, Chehelnabi A, Lovas J. Assessment of anxiety in intensive care patients by using the Faces Anxiety Scale. Am J Crit Care. 2004 Mar;13(2):146-52.

  PMID: 15043242 BACKGROUND

• Iyigun E, Pazar B, Tastan S. A study on reliability and validity of the Turkish version of the Face Anxiety Scale on mechanically-ventilated patients. Intensive Crit Care Nurs. 2016 Dec;37:46-51. doi: 10.1016/j.iccn.2016.05.002. Epub 2016 Jul 9.

  PMID: 27401047 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Esra OKSEL, PhD

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomised Controlled

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 23, 2024
• Study Start: April 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)