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5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders

Effects of a Venous Thromboembolism Prevention Program on the Occurrence of Venous Thromboembolism in Patients With Spinal Cord Disorders

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06302478
Enrollment
42
Registered
2024-03-08
Start date
2024-03-12
Completion date
2024-10-31
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nurse's Role, Spinal Cord Diseases, Spinal Cord Injuries, Venous Thromboembolism

Brief summary

The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or 5E program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are: * Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care? * Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care? * Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different? Participants in the intervention group will receive the 5E program, including * Education: health education regarding venous thromboembolism prevention * Elevation: leg elevation of 10-20 degrees * Exercise: ankle exercises * Enough fluid: adequate fluid uptake * Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission

Interventions

BEHAVIORAL5E program

Participants in the 5E program group will receive 7-day nursing interventions including * Education: health education regarding venous thromboembolism prevention * Elevation: leg elevation of 10-20 degrees * Exercise: ankle exercises * Enough fluid: adequate fluid uptake * Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission

Sponsors

Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

A quasi-experimental research (two group pretest-posttest design)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Caprini scores of 5-8 and \>8 * Able to communicate in the Thai language * Willing to participate in this study

Exclusion criteria

* Alteration of consciousness * Experiencing complications, including neurogenic shock and autonomic dysreflexia * Being pregnant * Having fluid restriction

Design outcomes

Primary

MeasureTime frameDescription
The rate of venous thromboembolismThe day before implementing the intervention and at 7 days after implementing interventionThe diagnosis of venous thromboembolism is confirmed by a Doppler ultrasound scan of the femoral vein and popliteal vein by a physician working at the study site. The physician will record the results in the data record form.

Secondary

MeasureTime frameDescription
Signs and symptoms of deep venous thrombosis and pulmonary embolismThe day before implementing the intervention and Day 1 - Day 7 after implementing interventionThe Well's Score for deep venous thrombosis (DVT) includes clinical parameters: active cancer or palliative (+1), paralysis (+1), recently bedridden for more than 3 days (+1), localized tenderness (+1), entire leg swelling (+1), calf swelling more than 3 cm compared with asymptomatic leg (+1), pitting edema (+1), previous DVT documented (+1), collateral superficial veins (non-varicose) (+1), and alternative diagnosis (-2). The Modified Well's Score for pulmonary embolism (PE) includes the following criteria: clinical signs and symptoms of DVT (3); an alternative diagnosis is less likely than PE (3); a heart rate greater than 100 (1.5); immobilization for 3 or more consecutive days (1.5); previous objectively diagnosed PE or DVT (1.5); hemoptysis (1); and malignancy (1).
Thigh and calf circumferenceThe day before implementing the intervention and Day 1 - Day 7 after implementing interventionThigh and calf circumferences will be measured in centimeters using the standardized measuring tape. The assistant researcher will record the results in the data record form.

Countries

Thailand

Contacts

Primary ContactWiphawadee Potisopha, Ph.D.
wiphpo@kku.ac.th+660954291592

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026