Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:47 AM
Study NCT ID:
NCT07475650
Status:
COMPLETED
Last Update Posted:
2026-03-16
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in ICU Patients With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-07', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Richard-Campbell Sleep Scale', 'timeFrame': '1 weeks', 'description': 'Patients in both the experimental and control groups were administered the Richard-Campbell Sleep Scale daily at 09:00 for one week to measure sleep depth, time to fall asleep, frequency of awakenings, wakefulness duration after waking, sleep quality, and ambient noise levels, and their overall sleep quality was observed.'}, {'measure': 'Beck Anxiety Scale', 'timeFrame': '1 weeks', 'description': 'The Beck Anxiety Scale was administered to patients in both the experimental and control groups at 09:00 on the first and seventh days and their anxiety levels were determined.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'VIRTUAL REALITY GLASSES', 'NURSING', 'SLEEP QUALITY', 'ANXIETY', 'VITAL SIGNS'], 'conditions': ['COPD', 'Sleep Quality of ICU Patients', 'Anxiety']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp', 'label': "Master's thesis"}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of a virtual reality glasses application on sleep quality, anxiety, and vital signs in patients with chronic obstructive pulmonary disease hospitalized in the intensive care unit. The study was conducted as a randomized controlled intervention study with 50 patients (25 experimental and 25 control) in the 2nd and 3rd level general intensive care units of Kayseri State Hospital. Patients in the experimental group received a 30 minute virtual reality session every evening for one week, while the control group received routine care. Sleep quality was assessed daily using the Richard-Campbell Sleep Scale, and anxiety levels were measured using the Beck Anxiety Scale. Vital signs were recorded before and after each VR session.', 'detailedDescription': 'The research was conducted as a randomized control group intervention study to determine the effect of virtual reality glasses application on sleep quality, anxiety and vital signs in COPD patients in intensive care. The sample of the study consisted of 50 patients (25 experimental and 25 control) who were diagnosed with COPD and met the study criteria in the 2nd and 3rd Level General ICU at Kayseri State Hospital between 29 November 2022 and 2 February 2024. In this study, for which ethics committee, institutional permission and participant approval were obtained, data were collected using virtual reality glasses, Patient Information Form, Vital Signs Follow-up Form, Richard-Campbell Sleep Scale and Beck Anxiety Scale. In the research, virtual reality glasses were applied to the patients in the experimental group for 30 minutes every evening at 23.30 for a week. Vital signs were measured immediately before and after the application and recorded in the Vital Signs Followup Form. Sleep quality was evaluated every day for a week with the RichardCampbell Sleep Scale. Anxiety levels were measured on the first and seventh days with the Beck Anxiety Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Conscious and oriented, able to cooperate\n* Aged 18 years and older\n* Diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2022 criteria (Stage II, Stage III, or Stage IV)\n* Hospitalized in the intensive care unit for at least 24 hours in order to evaluate sleep problems\n* No history of psychiatric disorders or cognitive impairment\n* No complaints such as migraine, dizziness, active nausea, vomiting, or headache\n* No visual, hearing, or cognitive impairments\n\nExclusion Criteria:\n\n* Patients with a Richmond Agitation-Sedation Scale (RASS) score less than -1\n* Patients receiving invasive or non-invasive mechanical ventilation\n\nDiscontinuation Criteria:\n\n* Experience problems with the virtual reality headset or report feeling unwell during the intervention\n* Initiation of any medication that affects sleep\n* Requirement for intubation\n* Initiation of medication for anxiety or sedation\n* Need for Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BPAP) during the virtual reality intervention'}, 'identificationModule': {'nctId': 'NCT07475650', 'acronym': 'VR-ICU-COPD', 'briefTitle': 'Virtual Reality in ICU Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'The Effect of Virtual Reality Glasses Application on Sleep Quality, Anxiety and Vital Signs in Intensive Care Patients With COPD', 'orgStudyIdInfo': {'id': 'ERU-MSN-CTY-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'In the research, virtual reality glasses were applied to the patients in the experimental group for 30 minutes every evening at 23.30 for a week. Vital signs were measured immediately before and after the application and recorded in the Vital Signs Followup Form. Sleep quality was evaluated every day for a week with the Richard-Campbell Sleep Scale. Anxiety levels were measured on the first and seventh days with the Beck Anxiety Scale.', 'interventionNames': ['Device: virtual reality glasses']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Patients in the control group received routine intensive care and standard COPD treatment without the virtual reality intervention. Sleep quality was evaluated every morning at 09:00 using the Richard-Campbell Sleep Scale for seven consecutive days. Anxiety levels were assessed using the Beck Anxiety Scale on the first and seventh days of the study. Vital signs were measured at 23:30 and 00:00 and recorded in the Vital Signs Follow-up Form.'}], 'interventions': [{'name': 'virtual reality glasses', 'type': 'DEVICE', 'otherNames': ['VR'], 'description': 'Patients in the experimental group received a virtual reality intervention for seven consecutive days. Each evening at 23:30, patients were placed in a supine position in their beds and a virtual reality headset was fitted comfortably around the head. The intervention lasted 30 minutes. During the session, patients watched 360-degree virtual reality videos with background music available including themes such as nature scenes, seaside walks, underwater views, and museum tours. Patients were allowed to choose the theme they preferred. Vital signs were measured immediately before the intervention at 23:30 and again at 00:00 after the intervention, and were recorded in the Vital Signs Follow-up Form. Sleep quality was assessed every morning at 09:00 using the Richard-Campbell Sleep Scale for seven days. Anxiety levels were evaluated using the Beck Anxiety Scale on the first and seventh days of the study.', 'armGroupLabels': ['experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38260', 'city': 'Kayseri', 'state': 'Melikgazi', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of Health Sciences Erciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Ceren TUNÇ YILDIZ, nurse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TC Erciyes University'}, {'name': 'Tülay BÜLBÜL, Doc.Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TC Erciyes University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse', 'investigatorFullName': 'Ceren Tunc Yildız', 'investigatorAffiliation': 'TC Erciyes University'}}}}