Clinical trial NCT05517148: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress
COVID-19 Pandemic
Nurse's Role
Keywords: Mindfulness-based Stress Reduction
Virtual Reality
COVID-19
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: up to 8 weeks
measure: Depression, anxiety, and stress scale (DASS-21)
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Work-related emotional score (WRE)
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: siting YANG
state: Jiangsu
city: Nanjing
country: China
facility: YANG Siting
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Yuxi Zhang, master
role: STUDY_DIRECTOR
References: