Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-02 @ 2:39 PM
Study NCT ID:
NCT05718661
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This research was designed using the experimental (intervention) research method. Under the same environment and conditions, to determine the effect on the same dependent variable, the intervention (experimental) group using virtual reality and the placebo group not using virtual reality (watching the same video with the naked eye), pre-test (measurement of the dependent variable before the intervention), post-test (dependent measurement of the variable after intervention). In addition, the group that was not interfered with will form the control group and a data collection form will be applied with an interval of 30 minutes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative Anxiety Level-1', 'timeFrame': '2 minute', 'description': 'stress level measured by smart bracelet VAS-A scale-before watching video. Minimum value: 0 and maximum value: 30'}, {'measure': 'Preoperative Anxiety Level-2', 'timeFrame': '2 minute', 'description': 'stress level measured by smart bracelet and VAS-A scale-after watching video. Minimum value:0, maximum value:30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety, preoperative period, virtual reality'], 'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '18550203', 'type': 'BACKGROUND', 'citation': 'Herrera-Espineira C, Rodriguez del Aguila Mdel M, Rodriguez del Castillo M, Valdivia AF, Sanchez IR. Relationship between anxiety level of patients and their satisfaction with different aspects of healthcare. Health Policy. 2009 Jan;89(1):37-45. doi: 10.1016/j.healthpol.2008.04.012. Epub 2008 Jun 11.'}, {'pmid': '20124283', 'type': 'BACKGROUND', 'citation': 'Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. Br J Anaesth. 2010 Mar;104(3):369-74. doi: 10.1093/bja/aeq002. Epub 2010 Feb 1.'}, {'pmid': '16033593', 'type': 'BACKGROUND', 'citation': 'Lin LY, Wang RH. Abdominal surgery, pain and anxiety: preoperative nursing intervention. J Adv Nurs. 2005 Aug;51(3):252-60. doi: 10.1111/j.1365-2648.2005.03502.x.'}, {'pmid': '32498771', 'type': 'BACKGROUND', 'citation': 'Hendricks TM, Gutierrez CN, Stulak JM, Dearani JA, Miller JD. The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. Mayo Clin Proc. 2020 Jun;95(6):1148-1157. doi: 10.1016/j.mayocp.2020.02.032.'}, {'pmid': '19377147', 'type': 'BACKGROUND', 'citation': 'Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.'}], 'seeAlsoLinks': [{'url': 'https://www.youtube.com/watch?v=uEMmpJgaXvo&ab_channel=4KRelaxationChannel', 'label': 'video that participants will watch with mobile virtual glasses - also video that participants will watch without virtual glasses'}]}, 'descriptionModule': {'briefSummary': "Hospitalization, medical interventions to be performed, and uncertainties specific to surgical intervention create a certain level of anxiety in the patient. It is known that being in the hospital negatively affects the coping mechanisms of the patient. In the pre-surgical period, the nurse's practices that will facilitate the patient's coping with the situation and managing his anxiety have a positive effect on anxiety during and after surgery and on anxiety-related symptoms. For these reasons, it is aimed to determine the effect of virtual reality on pre-surgical anxiety in this study.The hypothesis of the study is that watching videos with virtual glasses will reduce preoperative anxiety.", 'detailedDescription': 'Questions to be Answered in the Study The questions expected to be answered in the study to be conducted to evaluate the effect of acupressure application on the anxiety level in the preoperative period in patients who will undergo abdominal surgery;\n\n* What is the frequency of anxiety before abdominal surgery?\n* What is the effect of virtual reality on anxiety management before abdominal surgery?\n\nVariables of the Research Preoperative anxiety scale/level\n\nData Collection Tools Patient Information Form, VAS-A and a smart wristband with stress level measurement feature will be used to collect data.\n\nForm-1.Patient Information Form: It is a form consisting of sociodemographic questions created by the researchers.\n\nForm-2. Visual Anxiety Scale (VAS-A): The Numerical Anxiety Severity Scale consists of a horizontal line that begins with the expression "0" or "no anxiety" and ends with the expression "100" or "severe anxiety". The patient is asked to choose the number that best describes the pain, between 0 and 100, by showing the scale. The result of the scale was evaluated over the arithmetic mean (Carr et al 2005; Kindler et al 2000).\n\nSmart Wristband: A smart wristband with photoplethysmography (PPG) feature that detects and reports stress-related changes will be used.\n\nAfter assessing whether the data fit the normal distribution with the Kolmogorov Smirnov test, if the data fit the normal distribution, parametric tests (Single Sample t-Test, One- and Multi-Way Analysis of Variance, Spearman\'s Correlation Analysis); if the data do not fit the normal distribution, non-parametric tests (Mann-Whitney U Test, Kruskall Wallis Test, Friedman Test, Pearson\'s Correlation Analysis) will be used. Mean, standard deviation and percentage distribution methods will be used in the descriptive analysis of the data. The power of the sample will be calculated with the post hoc analysis to be made.\n\nThe universe of the research; Between 01.03.2023 and 01.12.2023, all patients who will undergo abdominal surgery in the Trakya University Health Research Center General Surgery Clinic will form.\n\nThe sample of the research; The sample will consist of individuals who meet the selection criteria and volunteer to participate in the research.\n\nSample of the Study: Mosso et al. (2009) in the study titled "Virtual reality on mobile phones to reduce anxiety in outpatient surgery" in which the anxiety levels of patients who used virtual reality in the preoperative period were evaluated using VAS-A. Accordingly, the effect size was calculated as d=0.920. In the calculation of the sample size, using the G-Power (G-Power 3.1.9.7, Kiel, Germany) program, effect size d=0.920, margin of error=0.05, power (1-β err probe)=0.95, 32 patients were included in each group. needed was determined. Using this number; For the initiative group; 32 patients For the control group; 32 patients For the placebo group; The total number of patients to be sampled was planned to be 96, 32 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18 years or older,\n* To be able to communicate in Turkish,\n* Volunteering to participate in the research\n* To have abdominal surgery\n* Not applying isolation to the patient\n* It was determined that there is no obstacle to communication.\n\nExclusion Criteria:\n\n* Not volunteering to participate in the research\n* To have a surgical intervention other than abdominal surgery\n* Failure to communicate\n* The patient is in isolation\n* Having a vision problem\n* Having a health problem that prevents using virtual glasses\n* Premedication has been applied'}, 'identificationModule': {'nctId': 'NCT05718661', 'briefTitle': 'The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery', 'orgStudyIdInfo': {'id': 'TUTF-GOBAEK 2022/240'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Glasses Group', 'description': 'The intervention group will watch a virtual reality video with mobile virtual glasses by the researcher (SŞ) and the stress level on the smart wristband will be recorded. In addition, necessary variables will be recorded with the data collection form.', 'interventionNames': ['Behavioral: Watching video with virtual glasses']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-Virtual Reality Glasses Group', 'description': 'The plain version of the video, which was shown to the intervention group by the researcher (SŞ) to the placebo group, will be watched over the phone with the naked eye and the stress level on the smart bracelet will be recorded. In addition, necessary variables will be recorded with the data collection form.', 'interventionNames': ['Behavioral: watching video without virtual glasses']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Anxiety control will be done by the researcher (SU) for the control group.'}], 'interventions': [{'name': 'Watching video with virtual glasses', 'type': 'BEHAVIORAL', 'description': "Using Mobile Virtual Glasses; In the preoperative period, after the patient is taken to the surgical service, a virtual reality video will be watched with mobile virtual glasses at the specified time (before going to the operating room on the day of surgery). Measurements will be made before and after the application. Necessary hygiene will be provided before the use of glasses, and the researcher will ensure hand cleaning before entering the patient's room.", 'armGroupLabels': ['Virtual Reality Glasses Group']}, {'name': 'watching video without virtual glasses', 'type': 'BEHAVIORAL', 'description': 'The plain version of the video, which was shown to the intervention group by the researcher (SŞ) to the placebo group, will be watched over the phone with the naked eye and the stress level on the smart bracelet will be recorded.', 'armGroupLabels': ['Non-Virtual Reality Glasses Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22000', 'city': 'Edirne', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sevim Sen, PhD', 'role': 'CONTACT', 'email': 'sen.sevim13@gmail.com', 'phone': '0090531906926'}], 'facility': 'Trakya University Hospital', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}], 'centralContacts': [{'name': 'Sevim Sen, PhD', 'role': 'CONTACT', 'email': 'sen.sevim13@gmail.com', 'phone': '00905319906926'}, {'name': 'Seher Unver, PhD', 'role': 'CONTACT', 'email': 'seherunver@trakya.edu.tr', 'phone': '00905055007217'}], 'overallOfficials': [{'name': 'Dogan Albayrak, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trakya University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'It will be decided to share the data after the ethics committee decision for which the study permit is obtained.', 'accessCriteria': 'The primary author is reached via e-mail and if requested, data will be shared with the consent of all authors.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sevim Akbal', 'investigatorAffiliation': 'Trakya University'}}}}