Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378970
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2024-04-06
Brief Title:
Audio Books Effects on Anxiety and Vital Sings
Sponsor:
Ege University
Organization:
Ege University
Study Overview
Official Title:
Effects of Audio Book Application on Anxiety and Vital Signs With Patients Who Receive NIMV Support
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MethodologyDesign 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 tabletsmartphone 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
Research MethodologyDesign 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 tabletsmartphone 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None