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Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Stress Reduction

Primary Purpose

Stress, COVID-19 Pandemic, Nurse's Role

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Therapeutic VR
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 Stress focused on measuring Mindfulness-based Stress Reduction, Virtual Reality, COVID-19

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eligible patients were aged 18 years or older, had stage IV cancer Estimated survival of 6-24 months (assessed by their main oncologist) Consenting patients completed baseline measures to be eligible.

Exclusion Criteria:

Visual or auditory impairment Inability to pass the cognitive screening test (The Mini-Mental State Examination) and patients deemed cognitively impaired at the discretion of the oncologist or psychologist were not eligible If they had received anxiety medication that morning would interfere with VR gameplay3 and Mindfulness-based stress reduction (MBSR) A history of seizure disorder.

Sites / Locations

  • siting YANG
  • YANG Siting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mindfulness-based Stress Reduction by Therapeutic VR

Mindfulness-based Stress Reduction

Arm Description

47 participates were randomized and allocated to this treatment group. During the study, seven individuals were lost, and a total of 40 nurses participated in the final statistics. Of the seven individuals lost, two withdrew from the intervention due to personal reasons, while the remaining five terminated the intervention due to COVID-19 infection. The therapeutic intervention consisted of an eight-week group intervention that included the same amount of contact and meditations as MBT.

Received the same mindfulness therapy training audio as the other set, but did not watch the 3D scene on the VR device. At the end of the study, we will compensate them and let them use VR for relaxation training according to their wishes.

Outcomes

Primary Outcome Measures

The Hamilton Anxiety Rating Scale (HAM-A)
The HAM-A contains items, each scored on a 5-point scale (0, asymptomatic; 1, mild symptoms; 2, moderate symptoms; 3, severe symptoms; 4, extremely severe symptoms). The total sum score, ranging from 0 to 56, can be classified into four levels: 0, no anxiety symptoms; 1-17, mild anxiety; 18-24, moderate anxiety; 25-56, severe anxiety
Depression, anxiety, and stress scale (DASS-21)
The questionnaire of the Chinese version of DASS-21 comprises 21 items that assess three negative emotional experiences, namely depression, anxiety, and stress (Jiang et al., 2021). The depression factor consists of seven items (3, 5, 10, 13, 16, 17, 21), which are related to pathological dysthymia, low self-esteem, and low level of positive emotions. The anxiety factor comprises seven items (2, 4, 7, 9, 15, 19, 20), that related to the somatic and subjective experience of anxiety arousal. The stress factor includes seven items (1, 6, 8, 11, 12, 14, 18), that relate to negative emotionally. A 4-point score System was used (0=completely disagree, 1=partially agree, 2=mostly agree, 3=completely agree). Higher scores indicate stronger negative emotional experiences (Gomez et al., 2014; Oei et al., 2013).

Secondary Outcome Measures

Work-related emotional score (WRE)
Nurses were asked to select a level of their mood at work during the COVID-19 to reflect their emotional attitude or degree of satisfaction towards work. The question posed was, "Has COVID-19 affected your mood at work?". The subjective scores range from 0 (no affected) to 10 (extremely affected).

Full Information

First Posted
August 23, 2022
Last Updated
May 21, 2023
Sponsor
Nanjing University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05517148
Brief Title
Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Stress Reduction
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
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 25, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Mindfulness-based stress reduction (MBSR), a widely used method to improve mental state and sleep quality, was developed by Kabat-Zinn in 1970. The meditation of MBSR is effective in regulating patients' emotions, leading to reduced stress, pain, and psychological symptoms. Studies have demonstrated that MBSR has a positive impact on multiple psychological and physical symptoms in a variety of cancers. On this basis, investigators found that VR treatment can also help patients relax, and it has been widely used in cancer symptom relief in recent years. VR treatment involves using headset devices that fully restrict the vision field to content displayed inside the headset screen; As a treatment modality, VR provides a unique environment comprising 3D visually immersive experiences that are enriched with stereo sounds and elements such as rich colors and scenic environments that enhance elicitation of desired states of arousal and affect. Within the therapeutic context, VR may be flexibly designed and tailored to address the needs of specific conditions (eg, anxiety, depression, pain) auditory perception is not fully restricted, though the corresponding device-delivered auditory content commands attention.
Detailed Description
Recently, studies have revealed that individuals who have survived a COVID-19 infection may experience a range of persistent symptoms (Comelli et al., 2022; Nalbandian et al., 2021), indicating that the pandemic is far from over and its aftermath is difficult to eliminate completely. At the same time, the COVID-19 pandemic has presented unprecedented challenges for nurses around the world. Not only are they at the forefront of preventing and controlling the spread of the virus, but they are also the primary caregivers for patients experiencing the after-effects of the pandemic. Meanwhile, they also need to care for the patients with other illness. Some study evidence indicated that there is a shortage of nurses during the COVID-19 pandemic, and nursing staff are experiencing a high level of negative emotions (Jiang et al., 2022; Zhang et al., 2022). The ongoing pandemic has had a huge impact on the mental health and work of nurses (Chen et al., 2021). Between 40% and 66.7% of surveyed health care workers reported mental health problems during the pandemic, according to a report by the OECD (Organisation for Economic Development and Cooperation, 2021). The stress caused by COVID-19 has contributed to workforce attrition, with many nurses opting to leave the profession (Organisation for Economic Development and Cooperation, 2021; World Health Organization, 2022). It has taken a heavy toll on the healthcare system. Maintaining the mental health of nurses is crucial. This is not only conducive to pandemic prevention and control, but also plays a significant role in the normal medical order.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, COVID-19 Pandemic, Nurse's Role
Keywords
Mindfulness-based Stress Reduction, Virtual Reality, COVID-19

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
The study utilized random sampling to recruit participants, and ethical approval was obtained prior to the commencement of the study. The participants were then divided into two groups through randomization, which was conducted by an independent researcher using the random number calculation procedure available at www.random.org. Following randomization, participants in the same department should were encouraged to adopt a unified intervention mode. Nurses working in the same department were assigned to the same group, and participants were not made aware of the existence of the other group existed. This form of masking is commonly used in randomised controlled trials to prevent potential bias from patients in the control group requesting the intervention or otherwise altering their behaviors. However, the investigators were aware of assignment. Before registering for this study, participants agreed to commence receiving the intervention in September 2022.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based Stress Reduction by Therapeutic VR
Arm Type
Experimental
Arm Description
47 participates were randomized and allocated to this treatment group. During the study, seven individuals were lost, and a total of 40 nurses participated in the final statistics. Of the seven individuals lost, two withdrew from the intervention due to personal reasons, while the remaining five terminated the intervention due to COVID-19 infection. The therapeutic intervention consisted of an eight-week group intervention that included the same amount of contact and meditations as MBT.
Arm Title
Mindfulness-based Stress Reduction
Arm Type
Other
Arm Description
Received the same mindfulness therapy training audio as the other set, but did not watch the 3D scene on the VR device. At the end of the study, we will compensate them and let them use VR for relaxation training according to their wishes.
Intervention Type
Device
Intervention Name(s)
Therapeutic VR
Other Intervention Name(s)
Mindfulness-based Stress Reduction
Intervention Description
Treatment module categories included: (1) Mindfulness-based stress reduction training: an audio conducting practice with breathing-based biofeedback training in immersive and interactive environments to support self-regulation and relaxation.
Primary Outcome Measure Information:
Title
The Hamilton Anxiety Rating Scale (HAM-A)
Description
The HAM-A contains items, each scored on a 5-point scale (0, asymptomatic; 1, mild symptoms; 2, moderate symptoms; 3, severe symptoms; 4, extremely severe symptoms). The total sum score, ranging from 0 to 56, can be classified into four levels: 0, no anxiety symptoms; 1-17, mild anxiety; 18-24, moderate anxiety; 25-56, severe anxiety
Time Frame
up to 8 weeks
Title
Depression, anxiety, and stress scale (DASS-21)
Description
The questionnaire of the Chinese version of DASS-21 comprises 21 items that assess three negative emotional experiences, namely depression, anxiety, and stress (Jiang et al., 2021). The depression factor consists of seven items (3, 5, 10, 13, 16, 17, 21), which are related to pathological dysthymia, low self-esteem, and low level of positive emotions. The anxiety factor comprises seven items (2, 4, 7, 9, 15, 19, 20), that related to the somatic and subjective experience of anxiety arousal. The stress factor includes seven items (1, 6, 8, 11, 12, 14, 18), that relate to negative emotionally. A 4-point score System was used (0=completely disagree, 1=partially agree, 2=mostly agree, 3=completely agree). Higher scores indicate stronger negative emotional experiences (Gomez et al., 2014; Oei et al., 2013).
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Work-related emotional score (WRE)
Description
Nurses were asked to select a level of their mood at work during the COVID-19 to reflect their emotional attitude or degree of satisfaction towards work. The question posed was, "Has COVID-19 affected your mood at work?". The subjective scores range from 0 (no affected) to 10 (extremely affected).
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Registered nurses (RNs) working in target departments, working in target departments, including. The target departments mainly included internal medicine, surgical, emergency department, were included in this study. These nurses had direct contact with COVID-19 patients, making them more susceptible to experiencing negative mental health effects due to increased work pressure. Predefined exclusion criteria included serious carsickness reaction, psychological crisis with a definite diagnosis, and not being engaged in nursing work related to COVID-19. Nurse managers in different departments recommended participants for the study, and interested nurses were contacted to provide basic information and complete evaluation content. Recruitment took place in September 2022. We recorded the enrolled nurses, related basic information and outcome measures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuxi Zhang, master
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
siting YANG
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210001
Country
China
Facility Name
YANG Siting
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Hope that the paper will be shared after it is accepted
Links:
URL
http://www.worldpediatricproject.org
Description
Refer to related definitions

Learn more about this trial

Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Stress Reduction

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