Trials / Completed
CompletedNCT06378970
Audio Books Effects on Anxiety and Vital Sings
Effects of Audio Book Application on Anxiety and Vital Signs With Patients Who Receive NIMV Support
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Ege University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-04-15
- Primary completion
- 2022-07-15
- Completion
- 2022-07-15
- First posted
- 2024-04-23
- Last updated
- 2024-04-23
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06378970. Inclusion in this directory is not an endorsement.