NCT05478642

Brief Summary

82.1% of patients with gunshot and mine-explosive wounds and wounds during hostilities in Ukraine have negative results of pain treatment, which leads to its chronicity. Examining the effect of psychological status on pain management outcomes in these patients may improve their treatment outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 24, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 26, 2022

Last Update Submit

July 28, 2022

Conditions

Chronic PainPsychological Disorders

Keywords

Chronic pain, gunshot wounds, mine-explosive wounds, psychological disorders

Outcome Measures

Primary Outcomes (5)

  • visual analog scale

    evaluation of the number of points

    12 months

  • Didier Bouhassiraa DN4

    evaluation of the number of points

    12 months

  • The Hospital Anxiety and Depression Scale

    evaluation of the number of points

    12 months

  • Chaban Quality of Life Scale

    evaluation of the number of points

    12 months

  • Mississippi PTSD scale (military version)

    evaluation of the number of points

    12 months

Study Arms (2)

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.

Other: The Hospital Anxiety and Depression Scale.

prospective study

Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022

Other: The Hospital Anxiety and Depression Scale.

Interventions

The Hospital Anxiety and Depression Scale.OTHER

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.

Also known as: Mississippi PTSD scale (military version), Chaban Quality of Life Scale
prospective studyretrospective analysis

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • availability gunshot and mine-explosive wounds

You may not qualify if:

  • absence gunshot and mine-explosive wounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bogomolets National Medical University, Ministry of Health of Ukraine

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Chronic PainMental DisordersWounds, Gunshot

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds, PenetratingWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2022

First Posted

July 28, 2022

Study Start

February 24, 2022

Primary Completion

May 24, 2022

Study Completion

May 24, 2022

Last Updated

August 1, 2022

Record last verified: 2022-07

Locations

UA(1)