- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05485337
Effectiveness of Therapeutic Tactics of Analgesia in Patients With Gunshot and Mine-explosive Wounds at the Stages of Treatment (ETTAPGM-EWST)
August 2, 2022 updated by: Vasyl' Horoshko, Bogomolets National Medical University
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.
Study Overview
Detailed 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.
Study Type
Observational
Enrollment (Actual)
2215
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kyiv, Ukraine
- Bogomolets National Medical University, Ministry of Health of Ukraine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
all patients were injured during hostilities
Description
Inclusion Criteria:
- the presence of gunshot wounds
Exclusion Criteria:
- no gunshot wounds
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
retrospective analysis
A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out.
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.
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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.
Other Names:
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prospective study
Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visual analog scale
Time Frame: 12 months
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from 0 to 10 points
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12 months
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The Hospital Anxiety and Depression Scale
Time Frame: 12 months
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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
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12 months
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Chaban Quality of Life Scale
Time Frame: 12 months
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up to 56 inclusive - a very low level 57-66 - low 67-75 - average 76-82 - tall 83-100 is very high
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12 months
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Mississippi PTSD scale (military version)
Time Frame: 12 months
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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
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12 months
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Didier Bouhassiraa DN4
Time Frame: 12 months
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4 or more points (a neuropathic pain component is present)
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2022
Primary Completion (Actual)
May 24, 2022
Study Completion (Actual)
May 24, 2022
Study Registration Dates
First Submitted
August 1, 2022
First Submitted That Met QC Criteria
August 2, 2022
First Posted (Actual)
August 3, 2022
Study Record Updates
Last Update Posted (Actual)
August 3, 2022
Last Update Submitted That Met QC Criteria
August 2, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- №158/23/05/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
I plan to share
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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