Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333431
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-13
Brief Title:
Effects of WN and WF During Gastroscopy
Sponsor:
Suleyman Demirel University
Organization:
Suleyman Demirel University
Study Overview
Official Title:
The Effects of Glass Waterfall and White Noise on Pain Anxiety and Physiological Parameters During Gastroscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
WFWN_GCPY
Brief Summary:
Background Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system including the esophagus stomach and duodenum The procedure is a difficult and stressful diagnosis and treatment method for the patient Problems such as stress fear and pain experienced during endoscopy cause anxiety
Purpose To examine effects of glass waterfall and white noise on pain anxiety and physiological parameters during gastroscopy Method The population of the study consists of all patients who applied to Mardin Education and Research Hospital Department of General Surgery Endoscopy Unit and were scheduled for gastroscopy The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample In calculating the sample of the study power analysis was performed and it was found the effect size of 116 95 power and 005 margin of error for this study that a total of 156 individuals for the three groups and at 52 individuals for each group Before gastroscopy procedure the patients included in the study will be randomly divided into three groups 52 glass waterfall group 52 white noise group and 52 control group
Purpose To examine effects of glass waterfall and white noise on pain anxiety and physiological parameters during gastroscopy Method The population of the study consists of all patients who applied to Mardin Education and Research Hospital Department of General Surgery Endoscopy Unit and were scheduled for gastroscopy The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample In calculating the sample of the study power analysis was performed and it was found the effect size of 116 95 power and 005 margin of error for this study that a total of 156 individuals for the three groups and at 52 individuals for each group Before gastroscopy procedure the patients included in the study will be randomly divided into three groups 52 glass waterfall group 52 white noise group and 52 control group
Detailed Description:
Background Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system including the esophagus stomach and duodenum The procedure is a difficult and stressful diagnosis and treatment method for the patient Problems such as stress fear and pain experienced during endoscopy cause anxiety
Purpose To examine effects of glass waterfall and white noise on pain anxiety and physiological parameters during gastroscopy Method The population of the study consists of all patients who will apply to Mardin Education and Research Hospital Department of General Surgery Endoscopy Unit and will be scheduled for gastroscopy The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample In calculating the sample of the study power analysis will be performed and it is found the effect size of 116 95 power and 005 margin of error for this study that a total of 156 individuals for the three groups and at 52 individuals for each group Before gastroscopy procedure the patients included in the study will be randomly divided into three groups 52 glass waterfall group 52 white noise group and 52 control group
Data will be collected in the endoscopy unit on weekdays when the procedure is performed All participants in the study will first fill out a patient identification form containing patient demographic information
Purpose To examine effects of glass waterfall and white noise on pain anxiety and physiological parameters during gastroscopy Method The population of the study consists of all patients who will apply to Mardin Education and Research Hospital Department of General Surgery Endoscopy Unit and will be scheduled for gastroscopy The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample In calculating the sample of the study power analysis will be performed and it is found the effect size of 116 95 power and 005 margin of error for this study that a total of 156 individuals for the three groups and at 52 individuals for each group Before gastroscopy procedure the patients included in the study will be randomly divided into three groups 52 glass waterfall group 52 white noise group and 52 control group
Data will be collected in the endoscopy unit on weekdays when the procedure is performed All participants in the study will first fill out a patient identification form containing patient demographic information
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