- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05478642
Influence of Psychological Status on the Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds (IPSRPTPGaM-EW)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Kyiv, Ukraine
- Bogomolets National Medical University, Ministry of Health of Ukraine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations.
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.
Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv.
Description
Inclusion Criteria:
- availability gunshot and mine-explosive wounds
Exclusion Criteria:
- absence gunshot and mine-explosive wounds
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
|
The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations. 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. Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv.
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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The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations. 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. Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv.
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
|
evaluation of the number of points
|
12 months
|
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Didier Bouhassiraa DN4
Time Frame: 12 months
|
evaluation of the number of points
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12 months
|
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The Hospital Anxiety and Depression Scale
Time Frame: 12 months
|
evaluation of the number of points
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12 months
|
|
Chaban Quality of Life Scale
Time Frame: 12 months
|
evaluation of the number of points
|
12 months
|
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Mississippi PTSD scale (military version)
Time Frame: 12 months
|
evaluation of the number of points
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12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 158 2022/23/05/
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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