Effects of an Immersive Virtual Reality Intervention

Sponsor

Nanjing University of Traditional Chinese Medicine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05637736

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nurse's Role COVID-19 Pandemic Mental Stress	Behavioral: Mindfulness-based Stress Reduction by Therapeutic VR Behavioral: Mindfulness-based Stress Reduction	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness-based Stress Reduction by Therapeutic VR	Behavioral: 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	Behavioral: Mindfulness-based Stress Reduction 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.

Arm

Intervention/Treatment

Experimental: Mindfulness-based Stress Reduction by Therapeutic VR

Behavioral: 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

Behavioral: Mindfulness-based Stress Reduction

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.

Outcome Measures

Primary Outcome Measures

Depression, anxiety, and stress scale (DASS-21) [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 [up to 8 weeks]
There is a separate questions. "Has COVID-19 affected your mood at work?"(0~10)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wu Ye	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

Nanjing University of Traditional Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huichao Zhang, Professor, Nanjing University of Traditional Chinese Medicine

ClinicalTrials.gov Identifier:

NCT05637736

Other Study ID Numbers:

NUCM22_0708

First Posted:

Dec 5, 2022

Last Update Posted:

Dec 5, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Stress, Psychological

Study Results

No Results Posted as of Dec 5, 2022