Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2019-12-10
2025-07-31
Brief Summary
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Detailed Description
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The aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women with cognitive complaints after breast cancer treatment. All participants will receive the initial screening to verify their cognitive status and then will be randomly assigned to the experimental or control group. The experimental group will receive a 4-week cognitive intervention by using a VR headset. Each VR content includes 10-12 video scenes with visual and auditory stimuli that were generated from nature.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Experimental: VR restorative intervention
Individuals who are assigned to the experimental group will receive a 4-week VR-based cognitive intervention.
Virtual reality-based cognitive intervention
This intervention consists of 12 different VR contents that were developed for this trial. Each content includes 10-12 scenes with visual and auditory stimuli generated from nature. Participants will view 3D nature videos using a VR headset for 20 minutes every other day, three times per week for one month.
Control: Usual care
Individuals who are assigned to the control group will receive the usual care and then receive the same intervention as they wish.
No interventions assigned to this group
Interventions
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Virtual reality-based cognitive intervention
This intervention consists of 12 different VR contents that were developed for this trial. Each content includes 10-12 scenes with visual and auditory stimuli generated from nature. Participants will view 3D nature videos using a VR headset for 20 minutes every other day, three times per week for one month.
Eligibility Criteria
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Inclusion Criteria
* Having affirmative responses to three questions about cognitive problems and their impact on daily performance
* Having FACT-Cog scores of 58 or less
* Having Mini-Cog scores of 3 and higher
* Having the ability to read, understand or respond to questionnaires and cognitive assessment
* Being willing to participate and able to provide written informed consent
Exclusion Criteria
* Having Patient Health Questionnaire-2 score of 3 and higher
* Being diagnosed with neurological disorders such as dementia, multiple sclerosis, or traumatic brain injury
* Having epilepsy or seizure
* Having 'quite a bit' or 'extremely' severe level of nausea and vomiting
* Having visual or hearing impairments
* Having other problems that prevent them from wearing the VR headset
19 Years
64 Years
FEMALE
No
Sponsors
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Chungnam National University
OTHER
Responsible Party
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Mi Sook Jung
Associate professor
Principal Investigators
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Mi Sook Jung, PhD
Role: PRINCIPAL_INVESTIGATOR
Chungnam National University
Locations
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Cognitive Health Education and Research Center
Daejeon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ChungnamNU.J1
Identifier Type: -
Identifier Source: org_study_id
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