Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04519931
Status:
UNKNOWN
Last Update Posted:
2021-07-01
First Post:
2020-08-17
Brief Title:
The Effect of Stress Ball Used During Endoscopy
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Saglik Bilimleri Universitesi
Study Overview
Official Title:
The Effect of Using a Stress Ball on Pain Anxiety and Satisfaction During the Endoscopy Procedure
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
RECRUITING
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:
Endoscopy procedure is a frequently used method in the evaluation of the gastrointestinal system Upper gastrointestinal system endoscopy can be performed with and without sedation Sedation is the controlled sleep of the patient with certain drugs pharmacological methods Non-pharmacological methods help reduce anxiety and pain In this study a non-pharmacological stress ball will be used It is aimed to evaluate the effect of using a stress ball on pain anxiety and satisfaction during upper gastrointestinal system endoscopy
Detailed Description:
Patients do not want to think that an upper GIS endoscopy without sedation will be difficult However some complications can be seen like hypoxemia allergic reaction malignant hyperthermia hypoventilation respiratory depression hypotension bradycardia apnea hypoxia etc due to sedation applied during endoscopy
Non-pharmacological methods help reduce anxiety and pain Although sedative and analgesic medications reduce anxiety and relieve pain endoscopy is still painful for patients During the endoscopy process non-pharmacological methods are used to draw attention to another direction but it is not encountered that the stress ball is used as one of these methods in the endoscopy procedure
This study was planned as a single-center prospective randomized controlled study for the treatment of the stress ball method used during the endoscopy procedure pain in anxiety and satisfaction levels
The data obtained in the study will be analyzed using the SPSS Statistical Package for Social Sciences for Windows 220 program Number percentage mean standard deviation will be used as descriptive statistical methods in the evaluation of data In comparing the difference between two independent groups Students t test will be used for data conforming to normal distribution and Mann-Whitney U test will be used for data that do not comply with normal distribution The difference between two repeated measurements will be analyzed with dependent groups t-test for data conforming to normal distribution and Wilcoxon test for data that do not conform to normal distribution The difference between three and more measurements that do not comply with the normal distribution will be compared with the analysis of variance in repeated measures for data that do not fit the normal distribution and with the Friedman test for data that do not comply with the normal distribution A value of P 005 will be considered as statistically significant
Non-pharmacological methods help reduce anxiety and pain Although sedative and analgesic medications reduce anxiety and relieve pain endoscopy is still painful for patients During the endoscopy process non-pharmacological methods are used to draw attention to another direction but it is not encountered that the stress ball is used as one of these methods in the endoscopy procedure
This study was planned as a single-center prospective randomized controlled study for the treatment of the stress ball method used during the endoscopy procedure pain in anxiety and satisfaction levels
The data obtained in the study will be analyzed using the SPSS Statistical Package for Social Sciences for Windows 220 program Number percentage mean standard deviation will be used as descriptive statistical methods in the evaluation of data In comparing the difference between two independent groups Students t test will be used for data conforming to normal distribution and Mann-Whitney U test will be used for data that do not comply with normal distribution The difference between two repeated measurements will be analyzed with dependent groups t-test for data conforming to normal distribution and Wilcoxon test for data that do not conform to normal distribution The difference between three and more measurements that do not comply with the normal distribution will be compared with the analysis of variance in repeated measures for data that do not fit the normal distribution and with the Friedman test for data that do not comply with the normal distribution A value of P 005 will be considered as statistically significant
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