Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
156 participants
INTERVENTIONAL
2024-04-03
2024-06-08
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Glass Waterfall
Except for the preparation the gastroscopy procedure takes approximately 20 minutes, patients will be asked to focus on portative glass waterfall during the procedure.
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.
White Noise
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
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
control group
Patients of the control group, will not receive any intervention except for applied routine hospital gastroscopy procedures.
No interventions assigned to this group
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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 any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.),
* Diagnosed with visual, auditory and / or balance disorders,
18 Years
ALL
Yes
Sponsors
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Suleyman Demirel University
OTHER
Responsible Party
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Hasan Genç
Asistant Professor
Principal Investigators
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Hasan GENC, PhD
Role: PRINCIPAL_INVESTIGATOR
Dicle University
Central Contacts
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References
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Utli H, Dogru BV. The Effect of Reiki on Anxiety, Stress, and Comfort Levels Before Gastrointestinal Endoscopy: A Randomized Sham-Controlled Trial. J Perianesth Nurs. 2023 Apr;38(2):297-304. doi: 10.1016/j.jopan.2022.08.010. Epub 2022 Oct 20.
Celebi D, Yilmaz E, Sahin ST, Baydur H. The effect of music therapy during colonoscopy on pain, anxiety and patient comfort: A randomized controlled trial. Complement Ther Clin Pract. 2020 Feb;38:101084. doi: 10.1016/j.ctcp.2019.101084. Epub 2019 Dec 23.
Huang MY, Scharf S, Chan PY. Effects of immersive virtual reality therapy on intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia: A randomized controlled trial. PLoS One. 2020 Feb 24;15(2):e0229320. doi: 10.1371/journal.pone.0229320. eCollection 2020.
Umezawa S, Higurashi T, Uchiyama S, Sakai E, Ohkubo H, Endo H, Nonaka T, Nakajima A. Visual distraction alone for the improvement of colonoscopy-related pain and satisfaction. World J Gastroenterol. 2015 Apr 21;21(15):4707-14. doi: 10.3748/wjg.v21.i15.4707.
Veldhuijzen G, Klaassen NJM, Van Wezel RJA, Drenth JPH, Van Esch AA. Virtual reality distraction for patients to relieve pain and discomfort during colonoscopy. Endosc Int Open. 2020 Jul;8(7):E959-E966. doi: 10.1055/a-1178-9289. Epub 2020 Jun 30.
Ilkkaya NK, Ustun FE, Sener EB, Kaya C, Ustun YB, Koksal E, Kocamanoglu IS, Ozkan F. The effects of music, white noise, and ambient noise on sedation and anxiety in patients under spinal anesthesia during surgery. J Perianesth Nurs. 2014 Oct;29(5):418-26. doi: 10.1016/j.jopan.2014.05.008.
Rostom A, Ross ED, Dube C, Rutter MD, Lee T, Valori R, Bridges RJ, Pontifex D, Webbink V, Rees C, Brown C, Whetter DH, Kelsey SG, Hilsden RJ. Development and validation of a nurse-assessed patient comfort score for colonoscopy. Gastrointest Endosc. 2013 Feb;77(2):255-61. doi: 10.1016/j.gie.2012.10.003.
Genc H, Tanriverdi S. The Effects of a Portative Glass Waterfall and a White Noise App On Pain, Anxiety, and Physiological Parameters During Gastroscopy. Pain Manag Nurs. 2025 Oct 22:S1524-9042(25)00288-7. doi: 10.1016/j.pmn.2025.10.001. Online ahead of print.
Other Identifiers
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WN/WF
Identifier Type: -
Identifier Source: org_study_id
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