NCT05734872

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.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration 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

October 26, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2024

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

February 7, 2023

Last Update Submit

February 17, 2023

Conditions

Keywords

Non-suicidal Self-injuryVirtual Reality TechnologyAdolescent

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to one month

Study Arms (2)

Experimental group

EXPERIMENTAL
Device: Virtual Reality Technology

Control group

OTHER
Other: Routine mental health course training

Interventions

Make a pair of glasses through virtual reality technology, through which participants can observe and participate in the treatment process.

Experimental group

Conduct mental health education for patients by making a speech.

Control group

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Those who have serious physical diseases
  • Those who cannot cooperate with the completion of virtual reality technology finally complete the intervention content\<50%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Fang Chen

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    STUDY CHAIR

Central Study Contacts

Fang Chen, bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 21, 2023

Study Start

October 26, 2022

Primary Completion

December 26, 2023

Study Completion

October 26, 2024

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations