NCT05637736

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

December 5, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

November 24, 2022

Last Update Submit

November 24, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    up to 8 weeks

  • The impact of COVID-19

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

    up to 8 weeks

Study Arms (2)

Mindfulness-based Stress Reduction by Therapeutic VR

EXPERIMENTAL
Behavioral: Mindfulness-based Stress Reduction by Therapeutic VR

mindfulness-based therapy

ACTIVE COMPARATOR
Behavioral: Mindfulness-based Stress Reduction

Interventions

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.

Mindfulness-based Stress Reduction by Therapeutic VR

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.

mindfulness-based therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Nurses who have not been involved in the COVID-19 volunteer service.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wu Ye

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

COVID-19Stress, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 5, 2022

Study Start

March 1, 2022

Primary Completion

November 30, 2022

Study Completion

December 30, 2022

Last Updated

December 5, 2022

Record last verified: 2022-11

Locations