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

• Sponsor: Bogomolets National Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05478642
• Collaborator: (none)
• Enrollment: 2,215
• Location: 1
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 757.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Psychological Disorders	Other: The Hospital Anxiety and Depression Scale.

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 2215 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Influence of Psychological Status on the Results of Pain Treatment in Patients With Gunshot and Mine-explosive Wounds
• Actual Study Start Date: Feb 24, 2022
• Actual Primary Completion Date: May 24, 2022
• Actual Study Completion Date: May 24, 2022

Arms and Interventions

Arm	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.	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.; Other Names: Mississippi PTSD scale (military version) Chaban Quality of Life 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.; 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: Mississippi PTSD scale (military version) Chaban Quality of Life Scale

Outcome Measures

Primary Outcome Measures

1. visual analog scale [12 months]

   evaluation of the number of points

2. Didier Bouhassiraa DN4 [12 months]

   evaluation of the number of points

3. The Hospital Anxiety and Depression Scale [12 months]

   evaluation of the number of points

4. Chaban Quality of Life Scale [12 months]

   evaluation of the number of points

5. Mississippi PTSD scale (military version) [12 months]

   evaluation of the number of points

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• availability gunshot and mine-explosive wounds

Exclusion Criteria:

• absence gunshot and mine-explosive wounds

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bogomolets National Medical University, Ministry of Health of Ukraine	Kyiv		Ukraine

Sponsors and Collaborators

• Bogomolets National Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vasyl' Horoshko, Principal Investigator, Bogomolets National Medical University
• ClinicalTrials.gov Identifier: NCT05478642
• Other Study ID Numbers: 158 2022/23/05/
• First Posted: Jul 28, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vasyl' Horoshko, Principal Investigator, Bogomolets National Medical University: Chronic pain, gunshot wounds, mine-explosive wounds, psychological disorders
• Additional relevant MeSH terms: Chronic Pain; Mental Disorders

Study Results

No Results Posted as of Aug 1, 2022