- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07935538
Effect of Hand Fist-Clenching Exercise Versus Topical Aloe Vera Gel in the Prevention of Peripheral Intravenous Catheter-Related Phlebitis Among Adult Patients
This study aims to evaluate and compare the effectiveness of hand fist-clenching exercises versus topical Aloe Vera gel in preventing peripheral intravenous catheter (PIVC)-related phlebitis among adult patients. Phlebitis is a common complication associated with IV therapy. The study will assess adult patients admitted to the internal medicine wards to determine which preventive intervention is more effective in reducing the incidence of phlebitis."
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fatima H Ali
- Phone Number: +9647711323620
- Email: fatima.h.ali@s.uokerbala.edu.iq
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-
Are adults aged 18 years and above.
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Require peripheral intravenous catheterization.
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Have no signs of phlebitis at the selected IV insertion site before catheterization.
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Have intact skin at the selected IV insertion site.
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Are conscious and able to cooperate with the study procedures.
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Are able to perform the hand fist-clenching exercise.
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Agree to participate in the study.
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Exclusion Criteria:Participants with:
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Patients with existing phlebitis at the selected IV insertion site.
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Patients with skin disorders or lesions at the selected IV insertion site.
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Patients with acute or chronic infections.
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Patients with peripheral vascular disease or vascular abnormalities affecting the selected limb.
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Patients with conditions that prevent or limit performing the hand fist-clenching exercise.
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Patients who are unconscious, confused, or unable to cooperate with the study procedures.
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Patients with a known allergy or hypersensitivity to Aloe Vera or any component of the topical gel.
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Patients requiring immediate removal of the peripheral intravenous catheter before completion of the observation period.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
|
|
|
Experimental: hand fist -clenching exercise
|
Initiation and Patient Education: Hand fist-clenching exercise will be initiated immediately after insertion of the peripheral intravenous catheter (PIVC). The exercise will be taught to the patient by the researcher, and the procedure will be demonstrated to ensure that the patient understands how to perform it. Exercise Procedure: The patient will perform the exercise by making a fist with the hand in which the PIVC is inserted. The fist will be maintained for 30 seconds to 1 minute for each repetition. Frequency and Duration: The exercise will be performed approximately 20 times during each session, with each session lasting 5-10 minutes. The exercise will be performed twice daily. Supervision: The patient's performance of the exercise will be conducted under the supervision of the researcher. |
|
Experimental: topical aloe vera gel
|
Catheter Insertion Site Preparation and Insertion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of peripheral intravenous catheter -related Phlebitis
Time Frame: assessed twice daily for 48 hours
|
The incidence of phlebitis will be assessed using the Visual Infusion Phlebitis (VIP) scale. The VIP scale ranges from 0 (no signs of phlebitis) to 5 (advanced stage of thrombophlebitis). A score of 1 or greater indicates the occurrence of phlebitis |
assessed twice daily for 48 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aloe vera-fist PIVC phlebitis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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