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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05478655
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 July 2022
Source Bogomolets National Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Mine-explosive wounds in the general structure of combat sanitary losses reach 25%. They are characterized by significant damage resulting in high intensity pain. In patients who received mine-explosive injuries in the conditions of hostilities, such pain has its own unique features. It is necessary to pay more attention to the problem of pain treatment in patients of this category, because about 87.2% of cases have negative results of treatment - it becomes chronic.


Description:

The peculiarities of pain in patients with mine-explosive wounds depending on the localization of the wound at the stages of treatment need 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. Since in 87.2% 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 1166
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: - chronic pain, mine-explosive wounds Exclusion Criteria: - absence of mine-explosive wounds

Study Design


Related Conditions & MeSH terms


Intervention

Other:
visual analog scale
VAS was studied: 1) before and after anesthesia - at the stage of the medical and nursing brigade, military mobile hospital, military medical clinical center; 2) at the stage of the medical and nursing team - within 2 days; 3) at the stage of the military mobile hospital - within 5 days; 4) at the stage of the military medical clinical center - within 7 days, at the time of discharge from the hospital and further 1, 3, 6, 12 months after the injury; 5) at the rehabilitation stage. Intervals between analgesia were also studied.

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 evaluation of the number of points 12 months
Primary Didier Bouhassiraa DN4 evaluation of the number of points 12 months
Primary The Hospital Anxiety and Depression Scale evaluation of the number of points 12 months
Primary Chaban Quality of Life Scale evaluation of the number of points 12 months
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