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Effects of an Immersive Virtual Reality Intervention

Primary Purpose

Nurse's Role, COVID-19 Pandemic, Mental Stress

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mindfulness-based Stress Reduction by Therapeutic VR
Mindfulness-based Stress Reduction
Sponsored by
Nanjing University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nurse's Role

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Wu Ye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-based Stress Reduction by Therapeutic VR

mindfulness-based therapy

Arm Description

Outcomes

Primary Outcome Measures

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
The impact of COVID-19
There is a separate questions. "Has COVID-19 affected your mood at work?"(0~10)

Secondary Outcome Measures

Full Information

First Posted
November 24, 2022
Last Updated
November 24, 2022
Sponsor
Nanjing University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05637736
Brief Title
Effects of an Immersive Virtual Reality Intervention
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nurse's Role, COVID-19 Pandemic, Mental Stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based Stress Reduction by Therapeutic VR
Arm Type
Experimental
Arm Title
mindfulness-based therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Stress Reduction by Therapeutic VR
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Stress Reduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression, anxiety, and stress scale (DASS-21)
Description
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
Time Frame
up to 8 weeks
Title
The impact of COVID-19
Description
There is a separate questions. "Has COVID-19 affected your mood at work?"(0~10)
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Wu Ye
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

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Effects of an Immersive Virtual Reality Intervention

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