Research on the Intervention of VR-based Emotion Regulation Technology on Adolescent Non-suicide Self-injury Behavior (VR)
Primary Purpose
Non-suicidal Self-injury
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Virtual Reality Technology
Routine mental health course training
Sponsored by
About this trial
This is an interventional treatment trial for Non-suicidal Self-injury focused on measuring Non-suicidal Self-injury, Virtual Reality Technology, Adolescent
Eligibility Criteria
Inclusion Criteria: According to the diagnostic criteria of NSSI in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders. Have a past history of non-suicidal self-injury behavior. No virtual reality technology intervention before enrollment. age: ≥ 18 to<24. Exclusion Criteria: Those who have serious physical diseases Those who cannot cooperate with the completion of virtual reality technology finally complete the intervention content<50%.
Sites / Locations
- Second Affiliated Hospital of Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Ottawa Self-injury Inventory Chinese Revision
This item describes the addictive characteristics of non-suicidal self-injury behavior. There are seven items in total. Add the seven items to get the original total score. The higher the original total score, the more addictive the non-suicidal self-injury behavior of the individual. The minimum value is 0 and maximum value is 28.
Secondary Outcome Measures
Full Information
NCT ID
NCT05734872
First Posted
February 7, 2023
Last Updated
February 17, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05734872
Brief Title
Research on the Intervention of VR-based Emotion Regulation Technology on Adolescent Non-suicide Self-injury Behavior
Acronym
VR
Official Title
Psychiatry Department of The Second Affiliated Hospital of Zhejiang University School of Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
December 26, 2023 (Anticipated)
Study Completion Date
October 26, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Non suicidal self injury (NSSI) has become a serious social and public health problem allover the world, and the incidence rate is increasing year by year. Although the aim of NSSI is not to suicide, but its negative impact is extremely serious, which will seriously threaten the physical and mental health of adolescents. Virtual Reality (VR), a computer simulation technology, can enable people to enter and experience the artificial virtual world in an immersive way, has been used for the auxiliary treatment of anxiety disorder, post-traumatic stress disorder and other diseases. This study explored the impact of VR on the depression and mental health of NSSI adolescents, so as to reduce the incidence of non-suicide self-injury behavior in NSSI adolescent patients and improve the quality of life of such patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-suicidal Self-injury
Keywords
Non-suicidal Self-injury, Virtual Reality Technology, Adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Virtual Reality Technology
Intervention Description
Make a pair of glasses through virtual reality technology, through which participants can observe and participate in the treatment process.
Intervention Type
Other
Intervention Name(s)
Routine mental health course training
Intervention Description
Conduct mental health education for patients by making a speech.
Primary Outcome Measure Information:
Title
Ottawa Self-injury Inventory Chinese Revision
Description
This item describes the addictive characteristics of non-suicidal self-injury behavior. There are seven items in total. Add the seven items to get the original total score. The higher the original total score, the more addictive the non-suicidal self-injury behavior of the individual. The minimum value is 0 and maximum value is 28.
Time Frame
up to one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
According to the diagnostic criteria of NSSI in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders.
Have a past history of non-suicidal self-injury behavior.
No virtual reality technology intervention before enrollment.
age: ≥ 18 to<24.
Exclusion Criteria:
Those who have serious physical diseases
Those who cannot cooperate with the completion of virtual reality technology finally complete the intervention content<50%.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Chen, bachelor
Phone
+86 15867161868
Email
2201066@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Chen
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Research on the Intervention of VR-based Emotion Regulation Technology on Adolescent Non-suicide Self-injury Behavior
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