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

NCT ID: NCT06302478

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2024-10-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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5E Program

Participants in the 5E program group will receive 7-day nursing interventions.

Group Type EXPERIMENTAL

5E program

Intervention Type BEHAVIORAL

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

Usual Care

Participants in the control group will receive 7-day usual care interventions, including health education regarding signs and symptoms of venous thromboembolism and IPC use if the participants experienced muscle power as grade 0.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Wiphawadee Potisopha

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chaiyaphum Hospital

Chaiyaphum, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Wiphawadee Potisopha, Ph.D.

Role: CONTACT

+660954291592

Facility Contacts

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Suchada Chindamart, BNS

Role: primary

+66619411828

Other Identifiers

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KhonKaenU001

Identifier Type: -

Identifier Source: org_study_id

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