Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT06883916
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2025-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality Environment Created in Preoperative Area and Hand Massage on Patient Outcomes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008405', 'term': 'Massage'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study was conducted to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. It was planned as a three-group, randomized controlled and interventional study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Anxiety Scale', 'timeFrame': 'The Surgical Anxiety Scale will be administered 5 minutes before the intervention assigned to the research groups (pre-test) and again 5 minutes after the completion of the massage or virtual reality intervention (post-test).', 'description': "The scale was developed by Burton et al. in 2018 to assess preoperative anxiety levels. Each item of the 17-item scale is answered between 0 and 5 points. It consists of three sub-dimensions reflecting individuals' health status, recovery process, and anxiety about procedures. Health-related anxiety is calculated by summing up items 7, 8, 9, 10, 12, and 13; recovery-related anxiety is calculated by summing up items 2, 14, 16, and 17; and procedure-related anxiety is calculated by summing up items 1, 3, 4, and 5. The total score of the scale is calculated by summing up all sub-dimension scores and the scores of three items not included in the sub-dimensions. A minimum of 0 and a maximum of 68 points can be obtained from the scale. A high total scale score indicates increased surgical anxiety."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoperative anxiety', 'preoperative patients', 'complementary and alternative therapies', 'massage', 'virtual reality'], 'conditions': ['Preoperative Patients', 'Surgical Procedures, Elective', 'Anxiety']}, 'referencesModule': {'availIpds': [{'id': 'Ethics Committee Approval', 'url': 'https://tip.cu.edu.tr/storage/Mevzuat/Kurullar%20Y%C3%B6nergesi.pdf', 'type': 'Informed Consent Form'}], 'references': [{'pmid': '27906757', 'type': 'BACKGROUND', 'citation': 'Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.'}, {'pmid': '30324926', 'type': 'BACKGROUND', 'citation': 'Niharika P, Reddy NV, Srujana P, Srikanth K, Daneswari V, Geetha KS. Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars. J Indian Soc Pedod Prev Dent. 2018 Oct-Dec;36(4):364-369. doi: 10.4103/JISPPD.JISPPD_1158_17.'}], 'seeAlsoLinks': [{'url': 'https://journals.lww.com/jped/fulltext/2018/36040/effects_of_distraction_using_virtual_reality.8.aspx', 'label': 'Effects of distraction using virtual reality technology on pain perception and anxiety levels in children during pulp therapy of primary molars'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. In addition, it's examined that if virtual reality glasses and hand massage execution is convenient way of to reduce anxiety in patients before surgery.\n\nThe main questions it aims to answer are:\n\n* Is there a significant difference between the study groups in terms of post-application anxiety level?\n* Is there a significant difference between the study groups in terms of post-application vital signs, pain and patient satisfaction? Researchers will compare responses to anxiety scales before and after the hand massage and virtual reality videos to see if they reduce anxiety levels.\n\nParticipants will:\n\n* In the virtual reality group, they will answer the questions on the surgical anxiety scale, watch the video with VR glasses and answer the questions on the scale again.\n* In the massage group, they will answer the questions on the surgical anxiety scale, and after the researcher gives them a hand massage, they will answer the questions on the scale again.", 'detailedDescription': "Surgical Anxiety Scale: The scale was developed by Burton et al. in 2018 to assess preoperative anxiety levels. Each item of the 17-item scale is answered between 0 and 5 points. It consists of three sub-dimensions reflecting individuals' health status, recovery process, and anxiety about procedures. Health-related anxiety is calculated by adding the scores given to items 7, 8, 9, 10, 12, and 13; recovery-related anxiety is calculated by adding the scores given to items 2, 14, 16, and 17; and procedure-related anxiety is calculated by adding the scores given to items 1, 3, 4, and 5. The total score of the scale is calculated by adding the scores of all sub-dimensions and the scores of the three items not included in the sub-dimensions. A minimum of 0 and a maximum of 68 points can be obtained from the scale. Although there is no cut-off point for the scale, it can be said that surgical anxiety increases as the total score of the scale increases."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will undergo elective surgery and whose general condition is ASA (American Society of Anesthesiology) classification I, II or III\n* Patients who are not sedated\n* Patients over the age of 18\n* Patients without a psychiatric or behavioral diagnosis\n* Patients who do not have a communication barrier due to hearing loss or spoken language\n\nExclusion Criteria:\n\n* Vertigo and motion sickness\n* Carpal tunnel syndrome\n* Hand cuts'}, 'identificationModule': {'nctId': 'NCT06883916', 'briefTitle': 'Effect of Virtual Reality Environment Created in Preoperative Area and Hand Massage on Patient Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Effect of Virtual Reality Environment Created in Preoperative Area and Hand Massage on Patient Outcomes', 'orgStudyIdInfo': {'id': 'Faculty of Health Sciences'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'description': 'Patients in the preoperative waiting unit were shown a video using virtual reality glasses for 10 minutes.', 'interventionNames': ['Behavioral: Virtual reality tour']}, {'type': 'EXPERIMENTAL', 'label': 'Massage', 'description': 'A hand massage lasting 5 minutes was applied to each hand by the researcher.', 'interventionNames': ['Behavioral: Massage']}], 'interventions': [{'name': 'Virtual reality tour', 'type': 'BEHAVIORAL', 'description': 'The glasses have a pre-loaded video containing nature images in their memory. The patient feels like they are walking in the natural environment shown in the video.', 'armGroupLabels': ['Virtual Reality']}, {'name': 'Massage', 'type': 'BEHAVIORAL', 'description': 'A hand massage was applied by the researcher for 5 minutes for each hand. The massage, which was performed using baby oil and a paper towel, lasted 10 minutes in total for both hands.', 'armGroupLabels': ['Massage']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adana', 'state': 'Sarıçam', 'country': 'Turkey (Türkiye)', 'facility': 'Balcali Hospital Health Application and Research Center', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'Sevban A Professor doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cukurova University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Since the research is conducted with real persons, sharing personal data is not ethically appropriate.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nursevim Aydıngülü', 'investigatorAffiliation': 'Cukurova University'}}}}