NCT06333431

Effects of WN and WF During Gastroscopy

The Effects of Glass Waterfall and White Noise on Pain, Anxiety and Physiological Parameters During Gastroscopy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Suleyman Demirel University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 1.16, 95% power and 0.05% 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 1.16, 95% power and 0.05% 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.

Conditions

• Misadventure During Endoscopic Examination

Interventions

Type	Name	Description
DEVICE	Glass Waterfall group	Except for the preparation the gastroscopy procedure takes approximately 20 minutes, patients will be asked to focus on portative glass waterfall during the procedure.
DEVICE	white noise group	Except for the preparation of the patient for the procedure, since the gastroscopy procedure takes approximately 20 minutes, 20-minute white noise be listened using phone

Timeline

• Start date: 2024-04-03
• Primary completion: 2024-05-30
• Completion: 2024-06-08
• First posted: 2024-03-27
• Last updated: 2024-03-27