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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05485337
Other study ID # ?158/23/05/2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 24, 2022
Est. completion date May 24, 2022

Study information

Verified date August 2022
Source Bogomolets National Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In 82.1% of patients with gunshot and mine-explosive wounds, pain becomes chronic, therefore, the study of the effectiveness of therapeutic tactics for pain relief in this category of patients at the stages of treatment will be important for improving the results of pain treatment.


Description:

The effectiveness of the therapeutic tactics of analgesia in patients with gunshot and mine-explosive wounds at the stages of treatment needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Given that in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.


Recruitment information / eligibility

Status Completed
Enrollment 2215
Est. completion date May 24, 2022
Est. primary completion date May 24, 2022
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: - the presence of gunshot wounds Exclusion Criteria: - no gunshot wounds

Study Design


Related Conditions & MeSH terms


Intervention

Other:
visual analog scale
Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury.

Locations

Country Name City State
Ukraine Bogomolets National Medical University, Ministry of Health of Ukraine Kyiv

Sponsors (1)

Lead Sponsor Collaborator
Bogomolets National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary visual analog scale from 0 to 10 points 12 months
Primary Didier Bouhassiraa DN4 4 or more points (a neuropathic pain component is present) 12 months
Primary The Hospital Anxiety and Depression Scale 0-7 is the norm 8-13 - mild depressive disorders 14-18 - depressive disorders of medium severity 19-22 - severe depressive disorders 23 and more - depressive disorders of a very severe degree of severity 12 months
Primary Chaban Quality of Life Scale up to 56 inclusive - a very low level 57-66 - low 67-75 - average 76-82 - tall 83-100 is very high 12 months
Primary Mississippi PTSD scale (military version) the mean values of the total score are 76±18 for well-adjusted servicemen, 86±26 for servicemen with mental disorders, and 130±18 for those with PTSD 12 months
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