- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05637736
Effects of an Immersive Virtual Reality Intervention
November 24, 2022 updated by: Huichao Zhang, Nanjing University of Traditional Chinese Medicine
Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Therapy on Mental Health in Nurses During the COVID-19 Pandemic: A Randomized Controlled Trial
Some recent studies demonstrated caregivers may experience negative emotions such as anxiety and sadness, which may also affect normal treatment during the epidemic.
As the pandemic continues, mental health support, encouragement , and a sense of purpose are needed to support healthcare workers.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jiangsu
-
Nanjing, Jiangsu, China, 210029
- Wu Ye
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Registered nurses (RN) who work in target departments were included. The target departments mainly included internal medicine, surgical, emergency department, where nurses had direct mutual engagement with patients.
Exclusion Criteria:
- Nurses who have not been involved in the COVID-19 volunteer service.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness-based Stress Reduction by Therapeutic VR
|
Therapeutic VR+MBT was provided using a head-mounted display which designed to enclose eyes and block external stimuli almost entirely.
Patients can see immersive natural scenes through VR devices and hear stereo sounds through headphones.
We uploaded a programme, which was designed to induce recordings of guided meditations (The same as the MBT), musics for meditation and consists of meditation-videos of 40 minutes.
We will guide patients to choose their favorite meditation videos, such as forest, seaside, lake, snow mountain, field and so on.
|
|
Active Comparator: mindfulness-based therapy
|
39 participates randomized and allocated to this group.
MBT was conducted as an 8-week group intervention.
Sessions typically began with formal mindfulness meditations that include breathing exercises, prolonged expiratory relaxation, body scan, and meditation.
MBT was delivered by the first author, who has specialized training in mindfulness meditation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression, anxiety, and stress scale (DASS-21)
Time Frame: up to 8 weeks
|
The questionnaire of the Chinese version of DASS-21 has a total of 21 items and measures three negative emotional experiences of depression, anxiety and stress
|
up to 8 weeks
|
|
The impact of COVID-19
Time Frame: up to 8 weeks
|
There is a separate questions.
"Has COVID-19 affected your mood at work?"(0~10)
|
up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Anticipated)
November 30, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
November 24, 2022
First Submitted That Met QC Criteria
November 24, 2022
First Posted (Actual)
December 5, 2022
Study Record Updates
Last Update Posted (Actual)
December 5, 2022
Last Update Submitted That Met QC Criteria
November 24, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUCM22_0708
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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