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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06302478
Other study ID # KhonKaenU001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 12, 2024
Est. completion date October 31, 2024

Study information

Verified date March 2024
Source Khon Kaen University
Contact Wiphawadee Potisopha, Ph.D.
Phone +660954291592
Email wiphpo@kku.ac.th
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date October 31, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
5E 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

Locations

Country Name City State
Thailand Chaiyaphum Hospital Chaiyaphum

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of venous thromboembolism The 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. The day before implementing the intervention and at 7 days after implementing intervention
Secondary Signs and symptoms of deep venous thrombosis and pulmonary embolism The 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).
The day before implementing the intervention and Day 1 - Day 7 after implementing intervention
Secondary Thigh and calf circumference Thigh 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. The day before implementing the intervention and Day 1 - Day 7 after implementing intervention
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