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

NCT05517148 | Completed

• 1 other identifier: SJCX22_0701
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress; COVID-19 Pandemic; Nurse's Role

Keywords

Mindfulness-based Stress Reduction; Virtual Reality; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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

  up to 8 weeks

• 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).

  up to 8 weeks

Secondary Outcomes (1)

• Work-related emotional score (WRE)

  up to 8 weeks

Study Arms (2)

Mindfulness-based Stress Reduction by Therapeutic VR

EXPERIMENTAL

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.

Device: Therapeutic VR

Mindfulness-based Stress Reduction

OTHER

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.

Device: Therapeutic VR

Interventions

Therapeutic VR DEVICE

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.

Also known as: Mindfulness-based Stress Reduction

Mindfulness-based Stress Reduction; Mindfulness-based Stress Reduction by Therapeutic VR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Nanjing University of Traditional Chinese Medicine: lead

Study Sites (2)

siting YANG

Nanjing, Jiangsu, 210001, China

Location

YANG Siting

Nanjing, Jiangsu, 210001, China

Location

Related Links

• Refer to related definitions

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuxi Zhang, master

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 26, 2022
• Study Start: September 25, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)