Clinical trial NCT06378970: Audio Books Effects on Anxiety and Vital Sings
Official title: Effects of Audio Book Application on Anxiety and Vital Signs With Patients Who Receive NIMV Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-invasive Mechanical Ventilation
Keywords: respiration support
anxiety
vital signs
audio book
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Facial Anxiety Scale
timeFrame: before intervention, 15th minute of intervention, 30th minute of intervention 30 minute after intervention
measure: Patient Follow-up Form
timeFrame: before intervention, 15th minute of intervention, 30th minute of intervention 30 minute after intervention
measure: Audio Book Application Preference Form
timeFrame: 4 month
measure: Patient Information Form
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University
state: İzmir
Study officials:
affiliation: Ege University
name: Esra OKSEL, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.