Clinical trial NCT06333431: Effects of WN and WF During Gastroscopy
Official title: The Effects of Glass Waterfall and White Noise on Pain, Anxiety and Physiological Parameters During Gastroscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Misadventure During Endoscopic Examination
Keywords: white noise
glass waterfall
anxiety, pain
gastroscopy
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment experimental model using randomized pretest and posttest with control group
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* 18 aged and over
* Written and verbal consent to participate in the study,
* Being conscious (person, place and time orientation),
* Undergoing gastroscopy for the first time

Exclusion Criteria:

* Having vision, hearing and communication problems
* Having any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.),
* Diagnosed with visual, auditory and / or balance disorders,

Primary outcomes:
measure: Patient Information Form
timeFrame: the fundamental characteristics of the patients will be filled in 15 minutes before the gastroscopy procedure
measure: Visual Analogue Scale (VAS)
timeFrame: Change from Baseline Visual Analogue Scale in 50 minutes
measure: State and Trait Anxiety Scale (STAI)
timeFrame: Change from Baseline The State and Trait Anxiety Scale in 50 minutes
measure: The Patient Observation Form
timeFrame: Change from Baseline The Patient Observation Form in 50 minutes
measure: Pulse rate before and after gatroscopy procedure
timeFrame: Change from Baseline Pulse rate in 50 minutes
measure: Respiratory rate before and after gatroscopy procedure
timeFrame: Change from Baseline Respiratory rate in 50 minutes
measure: Systolic and diastolic blood pressure before and after gatroscopy procedure
timeFrame: Change from Baseline Systolic and diastolic blood pressure in 50 minutes
measure: Oxygen saturation values before and after gatroscopy procedure
timeFrame: Change from Baseline Oxygen saturation values in 50 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dicle University
name: Hasan GENC, PhD
role: PRINCIPAL_INVESTIGATOR
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