Influence of Psychological Status on the Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds

Chronic Pain Clinical Trial

— IPSRPTPGaM-EW  

Official title:

Influence of Psychological Status on the Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05478642
• Other study ID #: 158 2022/23/05/
• Status: Completed
• 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
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The influence of the amount of damage and operative interventions on the results of pain treatment 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 its features. Since 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:

• availability gunshot and mine-explosive wounds

Exclusion Criteria:

• absence gunshot and mine-explosive wounds

Related Conditions & MeSH terms

• Chronic Pain
• Mental Disorders
• Psychological Disorders

Intervention

Other:
• The Hospital Anxiety and Depression Scale.
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.

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
Primary	Mississippi PTSD scale (military version)	evaluation of the number of points	12 months