Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-01 @ 8:06 AM
Study NCT ID:
NCT06935604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healing Hearts of Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-04-12', 'studyFirstSubmitQcDate': '2025-04-12', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in anxiety levels', 'timeFrame': 'baseline, immediately after the intervention', 'description': 'Anxiety levels measured by a Visual Analogue Scale - Anxiety (VAS-A), where participants rate their anxiety in a scale ranging from 0-10, with 0 representing no anxiety to 10 representing extreme anxiety. Higher scores indicate higher anxiety levels.'}], 'secondaryOutcomes': [{'measure': 'Change in pain levels', 'timeFrame': 'baseline, immediately after the intervention', 'description': 'Participants will complete the Numerical Rating Pain Scale (NRPS) immediately following each trial, where they rank pain sensitivity on an ordinal scale from 0 = no pain to 10 = worst pain. Higher scores indicate greater or worse pain.'}, {'measure': 'The Perceived Stress Scale', 'timeFrame': 'Baseline', 'description': 'Participants will complete the Perceived Stress Scale-10. It is a five-point Likert-type scale and consists of 10 items. Participants rate each item on a scale ranging from "Never (0)" to "Very often (4)". The total scores range from 0 to 40, and higher scores indicate greater perceived stress.'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': 'baseline, immediately after the intervention', 'description': 'The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items each, which is rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety, and lower scores indicating no or low anxiety.'}, {'measure': 'Change of Visual Analog Scale for Stress (VAS-Stress)', 'timeFrame': 'baseline, immediately after the intervention', 'description': 'Participants will complete the Visual Analog Scale for Stress (VAS-Stress). Visual analog scale to assess the perceived stress on a horizontal, non-calibrated line of 100 mm, ranging from very low stress (0) to very high stress (100). Higher scores indicate greater stress.'}, {'measure': 'Change in Loneliness as Measured by the UCLA 3-Item Loneliness Scale', 'timeFrame': 'baseline, immediately after the intervention', 'description': 'The UCLA 3-Item Loneliness Scale is a brief, validated self-report questionnaire used to assess subjective feelings of loneliness and social isolation. It consists of three items derived from the original UCLA Loneliness Scale. Each item is rated on a 3-point Likert scale (1 = Hardly Ever, 2 = Some of the Time, 3 = Often), yielding a total score ranging from 3 to 9. Higher scores indicate greater loneliness.'}, {'measure': 'Participant Satisfaction as Measured by a Self-Developed Satisfaction Survey', 'timeFrame': 'immediately after the intervention', 'description': 'Participants will complete the Self-Developed Satisfaction survey. The instrument includes 5 closed-ended items with varying response formats. Two questions are in binary formats, one question is in "Check all that apply" format, one question is on a 5-point Likert scale (1 = Very unlikely, 5=Very Likely) and one is in Numeric rating scales (NRS), response options ranging from 1-2 times to more than 5 times. Responses are coded on a 3-point ordinal scale (1 = 1-2 times, 2 = 3-4 times, 3 = more than 5 times).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality'], 'conditions': ['Pain', 'Anxiety', 'Stress', 'Loneliness']}, 'descriptionModule': {'briefSummary': 'The study aims to study virtual reality (VR) facilitation with adult inpatients using VR as a way to alter pain perception and reduce emotional distress during their hospitalization. Specifically, this study will evaluate the outcomes of patients who experience VR with and without a trained facilitator as a form of escapism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and above\n* Able to provide informed consent\n* Able to follow commands\n* Adequate motor skills for upper extremities to operate VR equipment\n* Clinically stable\n* English speaking\n* Willing to engage in VR\n\nExclusion Criteria:\n\n* Severe cognitive impairment\n* Facial trauma prohibiting headset use\n* Physical limitations in facial, neck, upper extremities that hinder use of VR equipment\n* Aggression or violence\n* Harm to self or others\n* Isolation room\n* History of seizures or other neurological conditions\n* Severe motion sickness\n* Active nausea\n* Severe visual impairment\n* Severe cognitive impairment'}, 'identificationModule': {'nctId': 'NCT06935604', 'briefTitle': 'Healing Hearts of Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Healing Hearts of Hospitalized Patients: A Randomized, Non-inferiority Study of Virtual Reality Facilitation', 'orgStudyIdInfo': {'id': '80473'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'VR a trained facilitator.', 'interventionNames': ['Behavioral: VR with a trained facilitator']}, {'type': 'EXPERIMENTAL', 'label': 'VR without a trained facilitator.', 'interventionNames': ['Behavioral: VR without a trained facilitator.']}], 'interventions': [{'name': 'VR with a trained facilitator', 'type': 'BEHAVIORAL', 'description': 'Intervention Group 1 - VR with a facilitator:\n\nEach participant in the intervention group will undergo a structured VR session, consisting of:\n\nDuration: 20 minutes Content: Immersive VR experience designed to promote relaxation and reduce pain.\n\nFacilitator training: The facilitator group will include trained healthcare professionals skilled in VR technology, C-I-CARE, and empathetic patient engagement. All facilitators also complete the Creative \\& Healing Arts Heart-to-Heart training which includes observation, empathy training, and reflection to support complex communication, and companionship needs of adult patients .', 'armGroupLabels': ['VR a trained facilitator.']}, {'name': 'VR without a trained facilitator.', 'type': 'BEHAVIORAL', 'description': 'Intervention Group 2 - VR without an inperson facilitator:\n\nEach participant in the intervention groups will undergo a structured VR session, consisting of:\n\nDuration: 20 minutes Content: Immersive VR experience designed to promote relaxation and reduce pain.\n\nInstructional video: A research assistant will use C-I-CARE to give the patient an instructional video and the headset to engage in the VR technology.\n\nPatients will take a surveys before and after the intervention', 'armGroupLabels': ['VR without a trained facilitator.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Health Care (SHC)', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Thomas Caruso, MD, PhD', 'role': 'CONTACT', 'email': 'tjcaruso@stanford.edu', 'phone': '6504970927'}, {'name': 'Man Yee Suen, MD', 'role': 'CONTACT', 'email': 'smy822@stanford.edu', 'phone': '6504970927'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Thomas Caruso', 'investigatorAffiliation': 'Stanford University'}}}}