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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05637736
Other study ID # NUCM22_0708
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date December 30, 2022

Study information

Verified date November 2022
Source Nanjing University of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 81
Est. completion date December 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Mindfulness-based Stress Reduction by Therapeutic VR
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
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.

Locations

Country Name City State
China Wu Ye Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary The impact of COVID-19 There is a separate questions. "Has COVID-19 affected your mood at work?"(0~10) up to 8 weeks
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