Nurse's RoleNCT05637736
Effects of an Immersive Virtual Reality Intervention
A study testing Mindfulness-based Stress Reduction by Therapeutic VR and Mindfulness-based Stress Reduction in people with Nurse's Role and COVID-19 Pandemic, run by Nanjing University of Traditional Chinese Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nurse's Role, COVID-19 Pandemic, Mental Stress
- What is being tested?
- Mindfulness-based Stress Reduction by Therapeutic VR and Mindfulness-based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Nurses who have not been involved in the COVID-19 volunteer service.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Nurse's Role, COVID-19 Pandemic, Mental Stress
- Being tested
- Mindfulness-based Stress Reduction by Therapeutic VR, Mindfulness-based Stress Reduction
- Medical subject headings
- COVID-19, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Stress Reduction by Therapeutic VRBehavioural
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.
Mindfulness-based Stress ReductionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Stress Reduction by Therapeutic VR | Experimental | Not described Receives: Behavioral: Mindfulness-based Stress Reduction by Therapeutic VR |
| mindfulness-based therapy | Active comparator | Not described Receives: Behavioral: Mindfulness-based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, anxiety, and stress scale (DASS-21)
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
Measured: up to 8 weeks
The impact of COVID-19
There is a separate questions. "Has COVID-19 affected your mood at work?"(0~10)
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Mar 2022
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huichao Zhang, Nanjing University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637736
- Sponsor's protocol ID
- NUCM22_0708
- Status last verified
- Nov 2022
- First submitted
- 24 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05637736
- Acronym / sponsor ID
- NUCM22_0708
- Conditions
- Nurse's Role, COVID-19 Pandemic, Mental Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Nanjing University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Stress Reduction by Therapeutic VR | Experimental | Behavioral: Mindfulness-based Stress Reduction by Therapeutic VR |
| mindfulness-based therapy | Active comparator | Behavioral: Mindfulness-based Stress Reduction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Nurses who have not been involved in the COVID-19 volunteer service.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Stress Reduction by Therapeutic VRTherapeutic 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. | Behavioural | Mindfulness-based Stress Reduction by Therapeutic VR |
| Mindfulness-based Stress Reduction39 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. | Behavioural | mindfulness-based therapy |
Primary outcome
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Stress Reduction by Therapeutic VR and Mindfulness-based Stress Reduction in people with Nurse's Role and COVID-19 Pandemic, run by Nanjing University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, anxiety, and stress scale (DASS-21) (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.