Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT07088367
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2025-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality Meditation on Anxiety in Cancer Patients Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-20', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-07-20', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State Anxiety', 'timeFrame': 'Immediately Before and after each intervention session, on Day 1, Day 2, and Day 3 (total of 6 measurement points)', 'description': 'Change in State Anxiety Score\n\nAnxiety levels will be measured using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S), a validated self-report tool.\n\nThe STAI-S consists of 20 items. Each item is rated on a 4-point Likert scale (1 = Not at all, 4 = Very much so). Total scores range from 20 to 80, with higher scores indicating greater anxiety.\n\nParticipants will complete the STAI-S before and after each VR session (or standard care, in the control group) on three consecutive days. This outcome will evaluate daily changes in state anxiety levels, and whether the intervention (VR meditation or VR video) leads to a significant reduction in anxiety compared to control.'}], 'secondaryOutcomes': [{'measure': 'Trait Anxiety', 'timeFrame': 'Day 1 (baseline, before the first intervention),Day 3 (after the last intervention session), andDay 30 (follow-up assessment)', 'description': 'Trait anxiety will be measured using the Trait Anxiety subscale of the State-Trait Anxiety Inventory (STAI-T), a validated self-report instrument.\n\nThe STAI-T consists of 20 items rated on a 4-point Likert scale (1 = Almost never, 4 = Almost always). Total scores range from 20 to 80, where higher scores indicate higher levels of trait (long-term) anxiety.\n\nThis outcome will assess changes in trait anxiety scores across three time points (baseline, post-intervention, and follow-up) to evaluate the immediate and sustained effects of virtual reality-based interventions compared to standard care. A reduction in scores will indicate a positive effect on long-term anxiety regulation.'}, {'measure': 'Virtual Reality Sickness', 'timeFrame': 'Immediately after each VR session on Day 1, Day 2, and Day 3', 'description': 'Virtual reality-induced discomfort will be assessed using the Virtual Reality Sickness Questionnaire (VRSQ), a standardized and validated instrument designed to measure symptoms such as dizziness, nausea, eye strain, and general discomfort during or after VR use.\n\nThe VRSQ consists of multiple items scored on a Likert-type scale. Higher total scores indicate greater levels of VR-induced discomfort.\n\nThis outcome will help evaluate the tolerability and usability of VR-based interventions in cancer patients receiving chemotherapy. It will also identify whether repeated exposure over three days influences the presence or intensity of VR sickness symptoms.\n\nNote: This assessment is only applied to participants in the virtual reality meditation and VR video groups, and is not administered to the control group.'}, {'measure': 'Participant Satisfaction with VR Intervention', 'timeFrame': 'Immediately after each VR session on Day 1, Day 2, and Day 3', 'description': 'Satisfaction with the virtual reality experience will be evaluated using a single-item visual analog scale ranging from 0 to 10, where:\n\n0 = Not satisfied at all\n\n10 = Extremely satisfied\n\nThis outcome will assess how participants perceived the comfort, usefulness, and overall satisfaction with the VR-based meditation or video intervention. Only participants in the intervention groups (VR meditation and VR video) will complete this measure.'}, {'measure': "Participant's Heart Rate", 'timeFrame': 'Immediately before and after each VR session on Day 1, Day 2, and Day 3.', 'description': "Vital signs will be measured immediately before and after each intervention session to assess the short-term physiological effects of the virtual reality experience. The following parameters will be recorded:\n\nHeart rate (per minute)\n\nChanges in these vital signs will be analyzed to determine whether the VR meditation or VR video sessions have any immediate impact on participants' physiological responses. The control group's measurements were taken at time points corresponding to those used in the intervention groups (e.g., 10 minutes after start for pre-test, 25th minute for post-test)."}, {'measure': "Participant's Respiratory Rate", 'timeFrame': 'Immediately before and after each VR session on Day 1, Day 2, and Day 3.', 'description': "Vital signs will be measured immediately before and after each intervention session to assess the short-term physiological effects of the virtual reality experience. The following parameters will be recorded:\n\nRespiratory rate (breaths per minute)\n\nChanges in these vital signs will be analyzed to determine whether the VR meditation or VR video sessions have any immediate impact on participants' physiological responses. The control group's measurements were taken at time points corresponding to those used in the intervention groups (e.g., 10 minutes after start for pre-test, 25th minute for post-test)."}, {'measure': "Participant's Blood Pressure", 'timeFrame': 'Immediately before and after each VR session on Day 1, Day 2, and Day 3.', 'description': "Vital signs will be measured immediately before and after each intervention session to assess the short-term physiological effects of the virtual reality experience. The following parameters will be recorded:\n\nBlood pressure (mmHg)\n\nChanges in these vital signs will be analyzed to determine whether the VR meditation or VR video sessions have any immediate impact on participants' physiological responses. The control group's measurements were taken at time points corresponding to those used in the intervention groups (e.g., 10 minutes after start for pre-test, 25th minute for post-test)."}, {'measure': "Participant's Oxygen Saturation", 'timeFrame': 'Immediately before and after each VR session on Day 1, Day 2, and Day 3.', 'description': "Vital signs will be measured immediately before and after each intervention session to assess the short-term physiological effects of the virtual reality experience. The following parameters will be recorded:\n\nOxygen saturation (SpO₂, %)\n\nChanges in these vital signs will be analyzed to determine whether the VR meditation or VR video sessions have any immediate impact on participants' physiological responses. The control group's measurements were taken at time points corresponding to those used in the intervention groups (e.g., 10 minutes after start for pre-test, 25th minute for post-test)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'anxiety'], 'conditions': ['Anxiety', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '37741768', 'type': 'BACKGROUND', 'citation': 'Uslu A, Arslan S. The Effect of Using Virtual Reality Glasses on Anxiety and Fatigue in Women with Breast Cancer Receiving Adjuvant Chemotherapy: A Pretest-Posttest Randomized Controlled Study. Semin Oncol Nurs. 2023 Oct;39(5):151503. doi: 10.1016/j.soncn.2023.151503. Epub 2023 Sep 22.'}, {'type': 'BACKGROUND', 'citation': 'Franklin, D. M., Silvestro, C., Carrillo, R. A., Yang, Y., Annadurai, D., Ganesan, S., Vasantham, D. S. J., Mettu, S., Patel, M., Patil, M. S., & Akurathi, N. D. (2023). The impact of meditation aided by VR technology as an emerging therapeutic to ease cancer related anxiety, stress, and fatigue. Frontiers in Virtual Reality, 4(July), 1-12. https://doi.org/10.3389/frvir.2023.1195196'}, {'pmid': '36758907', 'type': 'BACKGROUND', 'citation': 'Wu Y, Wang N, Zhang H, Sun X, Wang Y, Zhang Y. Effectiveness of Virtual Reality in Symptom Management of Cancer Patients: A Systematic Review and Meta-Analysis. J Pain Symptom Manage. 2023 May;65(5):e467-e482. doi: 10.1016/j.jpainsymman.2023.01.023. Epub 2023 Feb 8.'}, {'pmid': '32822755', 'type': 'BACKGROUND', 'citation': 'Chow H, Hon J, Chua W, Chuan A. Effect of Virtual Reality Therapy in Reducing Pain and Anxiety for Cancer-Related Medical Procedures: A Systematic Narrative Review. J Pain Symptom Manage. 2021 Feb;61(2):384-394. doi: 10.1016/j.jpainsymman.2020.08.016. Epub 2020 Aug 19.'}], 'seeAlsoLinks': [{'url': 'https://www.mediboothvr.com/', 'label': 'MediboothVR application'}, {'url': 'https://www.youtube.com/watch?app=desktop&v=Ba7f8xNKfVY&t=1s', 'label': 'Nature Video: Virture Forest Walk'}, {'url': 'https://www.youtube.com/watch?v=CorMkB9EHo0&t=1274s', 'label': 'Nature Video: Wetland Marsh Bird Sounds'}, {'url': 'https://www.youtube.com/watch?v=mBWj443FNGs&t=2519s', 'label': 'Nature Video: Stones of the Skagit River'}]}, 'descriptionModule': {'briefSummary': 'The main questions this study aims to answer are:\n\nDoes VR meditation, delivered through virtual reality glasses and the MediboothVR application, effectively reduce anxiety in cancer patients during chemotherapy?\n\nIs there a meaningful difference in anxiety reduction between the VR intervention groups and the control group?\n\nResearchers will compare two intervention groups using VR glasses-one with guided meditation and one with calming video content-to a control group receiving standard care, to see if there are differences in anxiety levels.\n\nParticipants will:\n\nBe randomly assigned to one of three groups\n\nAttend their scheduled chemotherapy sessions\n\nDepending on group assignment, either:\n\nUse VR glasses with the MediboothVR meditation app for 10 minutes daily\n\nUse VR glasses to watch calming 360-degree nature videos for 10 minutes daily\n\nReceive standard care with no VR use\n\nAll participants will complete anxiety questionnaires and have their vital signs recorded before and after each session.', 'detailedDescription': 'This clinical trial includes three parallel groups: a VR meditation group, a VR video group, and a control group.\n\nParticipants in the VR meditation group will receive a 10-minute virtual reality (VR) guided meditation session on three consecutive days, between 10:00 AM and 12:00 PM. The sessions will be delivered using virtual reality glasses and the MediboothVR application. A different meditation video will be used each day.\n\nThe MediboothVR application is the first immersive virtual reality meditation app developed in Türkiye and is also the first to support the Turkish language. It provides audio-guided meditation in a 360-degree artificial environment through virtual reality glasses. Each meditation video lasts approximately 10 minutes. Sessions begin with a short period for environmental observation, followed by a journey sequence that transports the user to a dedicated meditation area. A silhouette then appears and delivers the guided meditation experience through structured audio.\n\nParticipants in the VR video group will also use virtual reality glasses for 10 minutes each day, over three consecutive days, during the same time frame. Instead of meditation, they will watch 360-degree calming nature videos. A different video will be shown each day to support relaxation through immersive visual content.\n\nThese videos were selected to promote relaxation and included high-definition panoramic visuals such as forests, oceans, waterfalls, and mountain landscapes. Each day, a different video was used to maintain novelty and reduce visual fatigue. Although no verbal instructions were provided, the rich sensory environment was designed to offer a passive but calming distraction from the clinical setting.\n\nParticipants in the control group will receive standard nursing care without any VR-based intervention. After data collection is completed, participants in the control group will be offered the opportunity to experience the VR content, but their responses will not be included in the study analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older,\n* Sufficient communication ability to respond to study questions,\n* Receiving outpatient treatment for at least three consecutive days with a confirmed cancer diagnosis,\n* Scoring 40 or above on the State Anxiety Inventory (STAI-S), indicating moderate or higher anxiety levels,\n* Voluntarily agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Inability to speak or understand Turkish,\n* Being under contact isolation precautions,\n* Presence of active eye discharge or visual impairment,\n* History of seizures, epilepsy, or hypersensitivity to flashing lights,\n* History of vertigo or motion sickness,\n* Experiencing active nausea or vomiting,\n* Having wounds or dressings on the head or face that interfere with the use of a VR headset,\n* Hearing impairment,\n* Hypersensitivity of the face or scalp to light pressure,\n* Diagnosis of psychiatric conditions that may affect participation (e.g., schizophrenia, severe psychosis),\n* Diagnosis of recurrent or relapsed cancer,\n* Scoring below 40 on the State Anxiety Inventory,\n* Previous use of virtual reality applications,\n* Prior experience with meditation practices.'}, 'identificationModule': {'nctId': 'NCT07088367', 'briefTitle': 'Virtual Reality Meditation on Anxiety in Cancer Patients Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'The Effect of Virtual Reality Meditation on Anxiety Management in Cancer Patients Receiving Chemotherapy: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2024-126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality meditation group', 'description': 'Participants in this group will use a virtual reality (VR) headset to complete a 10-minute meditation session on three consecutive days. A different meditation video will be used each day, and sessions will be held between 10:00 AM and 12:00 PM. The meditation sessions are provided through the "MediboothVR" application. This app is the first immersive virtual reality meditation tool developed in Türkiye and supports the Turkish language.\n\nIn MediboothVR, participants experience a 360-degree guided meditation in a virtual environment. Each video starts with a short environmental scene, followed by a visual journey to a meditation space where a guiding silhouette appears and leads the participant through the session. Each session lasts approximately 10 minutes.', 'interventionNames': ['Behavioral: Virtual reality meditation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Reality Video Group', 'description': 'This group will use a VR headset on three consecutive days between 10:00 AM and 12:00 PM. Instead of meditation, participants will watch 360-degree nature videos. A different video (10 minute) will be shown each day. The purpose is to create a calming, immersive experience without guided meditation.', 'interventionNames': ['Behavioral: Virtual Reality Videos']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in the control group will receive standard nursing care without any VR intervention.'}], 'interventions': [{'name': 'Virtual reality meditation', 'type': 'BEHAVIORAL', 'description': 'This intervention involves immersive virtual reality (VR)-based guided meditation sessions using MediboothVR, the first Turkish-language supported virtual reality meditation application developed in Türkiye. It is distinct from other VR interventions in the following ways:\n\nCultural and language adaptation: MediboothVR is fully available in Turkish, providing culturally relevant audio-guided content. This makes it more accessible and emotionally resonant for Turkish-speaking participants, unlike many VR applications designed in other languages.\n\nDuration and consistency: The intervention is delivered over three consecutive days, with a different video used each day, each lasting approximately 10 minutes.\n\nTechnical delivery: The application is used exclusively via VR headsets, creating a fully immersive experience that eliminates visual and auditory distractions from the hospital environment.', 'armGroupLabels': ['Virtual reality meditation group']}, {'name': 'Virtual Reality Videos', 'type': 'BEHAVIORAL', 'description': 'This intervention involves the use of a virtual reality headset to present immersive 360-degree calming nature videos to participants. It is distinct from other video- or relaxation-based interventions in several key ways:\n\nDelivery via VR headset: Unlike standard video-based relaxation interventions presented on screens or tablets, this method delivers video content in a fully immersive virtual reality environment, which blocks out external visual and auditory stimuli from the unit.\n\nNon-guided and passive exposure: The video group receives no audio-guided instruction or meditation scripting, making it a purely visual and passive exposure intervention.\n\nCultural relevance and visual neutrality: The nature videos are non-verbal, visually neutral, and free of religious, symbolic, or emotionally provocative imagery, allowing them to be suitable for a diverse patient population.', 'armGroupLabels': ['Virtual Reality Video Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared. Results will be reported at the group level in scientific publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Gulbeyaz Can', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}