Trauma Related InjuriesNCT06944340
Evaluating the Impact of WHO Trauma Care Checklist on Clinical Outcome of Patients
A study testing WHO Trauma Care Checklist in people with Trauma Related Injuries and Trauma, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
This study is being conducted at the Department of Trauma and Orthopedics at Khyber Teaching Hospital, Peshawar. It will test whether using the World Health Organization (WHO) Trauma Care Checklist can help improve the care and recovery of patients who have experienced physical injuries (trauma). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trauma Related Injuries, Trauma
- What is being tested?
- WHO Trauma Care Checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Apr 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years old
- Glasgow Coma Scale (GCC) equal to or more than 10
- Consenting to participate in the study
Who cannot join
- Patients who do not meet the inclusion criteria
- Patients who refrain from continuing the study
- Patients with the incomplete checklist
- Pregnancy
- History of chronic mental illness, lung or kidney disease
- Undergoing chemotherapy.
- Illicit drug dependency
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Emergency Department, Khyber Teaching Hospital
Peshawar, KPK, 25000
About this study
Official title: Evaluating the Impact of World Health Organization Trauma Care Checklist on Clinical Outcome of Patients: A Prospective Randomized Controlled Trial
This study is being conducted at the Department of Trauma and Orthopedics at Khyber Teaching Hospital, Peshawar. It will test whether using the World Health Organization (WHO) Trauma Care Checklist can help improve the care and recovery of patients who have experienced physical injuries (trauma).
Injuries are a major cause of death and disability, especially in countries like Pakistan. When someone is seriously injured, doctors must act quickly and carefully to save lives and prevent long-term problems. Checklists are simple tools that help healthcare providers make sure nothing is missed during treatment.
Read more
In this study, adult trauma patients will be randomly divided into two groups:
One group will receive the standard trauma care (Group A). The other group will receive trauma care with the help of the WHO checklist (Group B).
Doctors will compare the outcomes of both groups by looking at things like pain levels, injury severity, recovery progress, complications (like infections or organ problems), and overall satisfaction. The goal is to see if the checklist makes a meaningful difference in patient recovery and safety.
Read the detailed description
Background
Trauma is one of the leading causes of mortality and long-term disability worldwide. In Pakistan, the burden of traumatic injuries is significant, especially among younger individuals. Contributing factors include road traffic accidents, workplace injuries, natural disasters, and violence. Despite being preventable and manageable in many cases, the lack of standardized emergency protocols and system-level interventions has resulted in suboptimal trauma care and increased complications. The WHO developed the TCC to support healthcare providers in delivering consistent, high-quality trauma care, especially in resource-limited settings.
Objective
This study aims to evaluate whether implementing the WHO Trauma Care Checklist during the initial assessment and management of trauma patients improves clinical outcomes compared to standard care alone. The primary hypothesis is that the checklist will help reduce complications, improve injury assessment accuracy, and enhance patient satisfaction.
Study Design and Setting
This is a prospective, single-blinded, randomized controlled trial being conducted at the Department of Trauma and Orthopedics, Khyber Teaching Hospital, Peshawar. The study will be conducted over six months following ethical approval.
Participants
A total of 60 adult trauma patients (aged 18-60 years) who meet specific inclusion criteria will be enrolled using simple random sampling. Participants will be randomly allocated to one of two groups:
Group A: Standard trauma care without the WHO checklist Group B: Standard trauma care with the WHO checklist Patients with severe comorbidities, pregnancy, chemotherapy, chronic mental illness, or substance abuse will be excluded.
Intervention
The WHO Trauma Care Checklist will be used by the clinical team during the initial management of patients in Group B. The checklist includes key safety steps related to airway, breathing, circulation, disability assessment, and exposure/environment, along with other evidence-based practices to prevent missed injuries and reduce medical errors.
Data Collection and Tools
Baseline demographic and clinical data will be collected at admission. Outcome assessments will include:
Improvement in Injury Severity Score (ISS) Visual Analogue Scale (VAS) for pain Glasgow Coma Scale (GCS) Duration of hospital stay and number of bed-bound days Occurrence of complications (e.g., sepsis, renal failure, pneumonia, wound infection) Mortality Missed injuries at presentation Patient satisfaction (rated on a 1-10 scale) Medical charts, direct observation, and patient interviews will serve as the primary data sources. Injury severity will be assessed by trained researchers using a standardized scoring system.
Follow-Up
Patients will be followed during their hospital stay and for one month post-discharge through phone calls or in-person visits. All outcomes will be assessed both at discharge and during the follow-up period.
Data Analysis
SPSS will be used for statistical analysis. Descriptive statistics will summarize patient characteristics and clinical outcomes. Independent t-tests and chi-square tests will compare outcomes between groups. A significance level of p < 0.05 will be used.
Significance
The results of this trial will help determine whether the WHO Trauma Care Checklist improves trauma care quality and outcomes in a low-resource hospital setting. If effective, the checklist could be implemented more widely to enhance trauma care across similar settings.
- Conditions
- Trauma Related Injuries, Trauma
- Being tested
- WHO Trauma Care Checklist
- Keywords
- Trauma, Trauma Outcomes, WHO Trauma Care Checklist, Trauma Checklist, Injury, Emergency Care
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO Trauma Care ChecklistOther
A standardized checklist developed by the WHO for trauma care, designed to reduce errors and ensure compliance with critical steps in trauma management.
Implemented by trained clinicians during patient assessment and treatment phases. Components include verification of patient identity, assessment of airway/breathing/circulation, pain management, monitoring for missed injuries, and post-resuscitation care. Checklist use is documented in medical records.
| Study group | Role | What they receive |
|---|---|---|
| Standard Trauma Care | No intervention | Patients receive routine trauma care adhering to the hospital's existing protocols without using the WHO Trauma Care Checklist. Treatment includes stabilization, diagnostics, surgical/non-surgical interventions, and post-operative care as per institutional standards. |
| WHO Trauma Care Checklist-Guided Care | Experimental | Patients receive trauma care guided by the WHO Trauma Care Checklist. The checklist is systematically applied by trained clinicians at critical stages of care (e.g., admission, pre-operative, post-operative, and discharge phases) to ensure adherence to evidence-based practices, including airway management, hemorrhage control, infection prevention, and monitoring for complications. Receives: Other: WHO Trauma Care Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Injury Severity Score (ISS)
difference in ISS at admission and after initial management. A higher difference means a better outcome.
Measured: Assessed at admission and after initial management.
Glasgow Coma Scale (GCS) Score
Consciousness levels of participant. Average change/rise/fall. Higher GCS means better outcome
Measured: Measured at presentation and 1 hour post-treatment.
level of Pain
Pain levels using the Visual Analogue Scale (VAS). A lower VAS score means better outcome.
Measured: Assessed after initial management.
Secondary outcomes (5)
All-Cause Mortality Rate
Incidence of death within 1 month post-trauma.
Measured: 1 month post-treatment.
Incidence of Post-Trauma Complications
Rates of complications (e.g., cardiac arrest, pneumonia, pulmonary embolism, sepsis, wound infections).
Measured: 1 month post-treatment
Number of Bed-Bound Days
Duration of immobilization during hospitalization
Measured: From admission to discharge (up to 1 month)
Patient Satisfaction Score
Patient-reported satisfaction with care quality on a scale of 1-10. Higher scores mean better outcomes.
Measured: Assessed at 1 month follow-up.
Rate of Missed Injuries
Proportion of injuries undetected during initial assessment.
Measured: Identified during 1-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start26 Apr 2025
- Primary completion15 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trauma Related InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group, single-blinded, parallel assignment randomized controlled trial. Patients are randomly allocated to either receive standard trauma care (control group) or standard care enhanced with the WHO Trauma Care Checklist (intervention group). Outcomes are compared between groups over a 1-month follow-up period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rao Erbaz Hassan, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944340
- Sponsor's protocol ID
- 526/DME/KMC
- Status last verified
- Sep 2025
- First submitted
- 15 Apr 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hyder AA, Razzak JA. The challenges of injuries and trauma in Pakistan: an opportunity for concerted action. Public Health. 2013 Aug;127(8):699-703. doi: 10.1016/j.puhe.2012.12.020. Epub 2013 Mar 13.
PubMed 23489711Bidhendi S, Ahmadi A, Fouladinejad M, Bazargan-Hejazi S. Evaluating implementation of WHO Trauma Care Checklist vs. modified WHO checklist in improving trauma patient clinical outcomes and satisfaction. J Inj Violence Res. 2021 Jan;13(1):5-12. doi: 10.5249/jivr.v13i1.1579. Epub 2020 Aug 16.
PubMed 32868497
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of World Health Organization Trauma Care Checklist on Clinical Outcome of Patients: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06944340
- Acronym / sponsor ID
- 526/DME/KMC
- Conditions
- Trauma Related Injuries, Trauma
- Keywords
- Trauma, Trauma Outcomes, WHO Trauma Care Checklist, Trauma Checklist, Injury, Emergency Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 26 Apr 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted at the Department of Trauma and Orthopedics at Khyber Teaching Hospital, Peshawar. It will test whether using the World Health Organization (WHO) Trauma Care Checklist can help improve the care and recovery of patients who have experienced physical injuries (trauma).
Injuries are a major cause of death and disability, especially in countries like Pakistan. When someone is seriously injured, doctors must act quickly and carefully to save lives and prevent long-term problems. Checklists are simple tools that help healthcare providers make sure nothing is missed during treatment.
In this study, adult trauma patients will be randomly divided into two groups:
One group will receive the standard trauma care (Group A). The other group will receive trauma care with the help of the WHO checklist (Group B).
Doctors will compare the outcomes of both groups by looking at things like pain levels, injury severity, recovery progress, complications (like infections or organ problems), and overall satisfaction. The goal is to see if the checklist makes a meaningful difference in patient recovery and safety.
Detailed description
Background
Trauma is one of the leading causes of mortality and long-term disability worldwide. In Pakistan, the burden of traumatic injuries is significant, especially among younger individuals. Contributing factors include road traffic accidents, workplace injuries, natural disasters, and violence. Despite being preventable and manageable in many cases, the lack of standardized emergency protocols and system-level interventions has resulted in suboptimal trauma care and increased complications. The WHO developed the TCC to support healthcare providers in delivering consistent, high-quality trauma care, especially in resource-limited settings.
Objective
This study aims to evaluate whether implementing the WHO Trauma Care Checklist during the initial assessment and management of trauma patients improves clinical outcomes compared to standard care alone. The primary hypothesis is that the checklist will help reduce complications, improve injury assessment accuracy, and enhance patient satisfaction.
Study Design and Setting
This is a prospective, single-blinded, randomized controlled trial being conducted at the Department of Trauma and Orthopedics, Khyber Teaching Hospital, Peshawar. The study will be conducted over six months following ethical approval.
Participants
A total of 60 adult trauma patients (aged 18-60 years) who meet specific inclusion criteria will be enrolled using simple random sampling. Participants will be randomly allocated to one of two groups:
Group A: Standard trauma care without the WHO checklist Group B: Standard trauma care with the WHO checklist Patients with severe comorbidities, pregnancy, chemotherapy, chronic mental illness, or substance abuse will be excluded.
Intervention
The WHO Trauma Care Checklist will be used by the clinical team during the initial management of patients in Group B. The checklist includes key safety steps related to airway, breathing, circulation, disability assessment, and exposure/environment, along with other evidence-based practices to prevent missed injuries and reduce medical errors.
Data Collection and Tools
Baseline demographic and clinical data will be collected at admission. Outcome assessments will include:
Improvement in Injury Severity Score (ISS) Visual Analogue Scale (VAS) for pain Glasgow Coma Scale (GCS) Duration of hospital stay and number of bed-bound days Occurrence of complications (e.g., sepsis, renal failure, pneumonia, wound infection) Mortality Missed injuries at presentation Patient satisfaction (rated on a 1-10 scale) Medical charts, direct observation, and patient interviews will serve as the primary data sources. Injury severity will be assessed by trained researchers using a standardized scoring system.
Follow-Up
Patients will be followed during their hospital stay and for one month post-discharge through phone calls or in-person visits. All outcomes will be assessed both at discharge and during the follow-up period.
Data Analysis
SPSS will be used for statistical analysis. Descriptive statistics will summarize patient characteristics and clinical outcomes. Independent t-tests and chi-square tests will compare outcomes between groups. A significance level of p < 0.05 will be used.
Significance
The results of this trial will help determine whether the WHO Trauma Care Checklist improves trauma care quality and outcomes in a low-resource hospital setting. If effective, the checklist could be implemented more widely to enhance trauma care across similar settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-group, single-blinded, parallel assignment randomized controlled trial. Patients are randomly allocated to either receive standard trauma care (control group) or standard care enhanced with the WHO Trauma Care Checklist (intervention group). Outcomes are compared between groups over a 1-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| Standard Trauma Care | No intervention | –Patients receive routine trauma care adhering to the hospital's existing protocols without using the WHO Trauma Care Checklist. Treatment includes stabilization, diagnostics, surgical/non-surgical interventions, and post-operative care as per institutional standards. |
| WHO Trauma Care Checklist-Guided Care | Experimental | Other: WHO Trauma Care ChecklistPatients receive trauma care guided by the WHO Trauma Care Checklist. The checklist is systematically applied by trained clinicians at critical stages of care (e.g., admission, pre-operative, post-operative, and discharge phases) to ensure adherence to evidence-based practices, including airway management, hemorrhage control, infection prevention, and monitoring for complications. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 60 years old
- Glasgow Coma Scale (GCC) equal to or more than 10
- Consenting to participate in the study
Key exclusion criteria (7 listed)
- Patients who do not meet the inclusion criteria
- Patients who refrain from continuing the study
- Patients with the incomplete checklist
- Pregnancy
- History of chronic mental illness, lung or kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHO Trauma Care ChecklistA standardized checklist developed by the WHO for trauma care, designed to reduce errors and ensure compliance with critical steps in trauma management. Implemented by trained clinicians during patient assessment and treatment phases. Components include verification of patient identity, assessment of airway/breathing/circulation, pain management, monitoring for missed injuries, and post-resuscitation care. Checklist use is documented in medical records. | Other | WHO Trauma Care Checklist-Guided Care |
Primary outcome
Improvement in Injury Severity Score (ISS)
Time frame: Assessed at admission and after initial management.
difference in ISS at admission and after initial management. A higher difference means a better outcome.
Glasgow Coma Scale (GCS) Score
Time frame: Measured at presentation and 1 hour post-treatment.
Consciousness levels of participant. Average change/rise/fall. Higher GCS means better outcome
level of Pain
Time frame: Assessed after initial management.
Pain levels using the Visual Analogue Scale (VAS). A lower VAS score means better outcome.
5 secondary outcomes
All-Cause Mortality Rate
Time frame: 1 month post-treatment.
Incidence of Post-Trauma Complications
Time frame: 1 month post-treatment
Number of Bed-Bound Days
Time frame: From admission to discharge (up to 1 month)
Patient Satisfaction Score
Time frame: Assessed at 1 month follow-up.
Rate of Missed Injuries
Time frame: Identified during 1-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 23489711Hyder AA, Razzak JA. The challenges of injuries and trauma in Pakistan: an opportunity for concerted action. Public Health. 2013 Aug;127(8):699-703. doi: 10.1016/j.puhe.2012.12.020. Epub 2013 Mar 13.
- Background: PubMed 32868497Bidhendi S, Ahmadi A, Fouladinejad M, Bazargan-Hejazi S. Evaluating implementation of WHO Trauma Care Checklist vs. modified WHO checklist in improving trauma patient clinical outcomes and satisfaction. J Inj Violence Res. 2021 Jan;13(1):5-12. doi: 10.5249/jivr.v13i1.1579. Epub 2020 Aug 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO Trauma Care Checklist in people with Trauma Related Injuries and Trauma, run by Khyber Teaching Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Injury Severity Score (ISS) (time frame: Assessed at admission and after initial management.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06944340, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.