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Comparison of Magnesium Sulphate Versus Cold Compress in IV Cannula Induces Phlebitis

Primary Purpose

Patient With IV Cannula Induce Phlebitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
comparison of magnesium sulphate versus cold compression
Sponsored by
University of Health Sciences Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patient With IV Cannula Induce Phlebitis focused on measuring comparison, Magnesium Sulphate, Cold Compress, Phlebitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The patient admitted for 72 hours or more than 72 hours. Patient with intravenous therapy. Patients with signs of phlebitis 2-4 score on the VIP scale. Age group of 18-50 years and able to report pain. Exclusion Criteria: Patient with superficial thrombophlebitis and having skin disorder. Patient having associated muscular disorders like DVT, varicose veins,s, etc. Patient with disturbed coagulation profile. I.V Drug abusers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Magnesuuim Sulphate

    Cold compression

    Arm Description

    After the initial assessment, the cannula will be removed from the site (if present) the cannulation site will be cleaned with normal saline. A mixture of 100mg magnesium sulfate and glycerin will be applied to a gauze pad (2" × 2"). This gauze pad placed on the site of phlebitis induced by peripheral intravenous catheter (PIVC). This will be done three times a day for three consecutive days

    After the initial assessment, the cannula will be removed from the site (if present) and the area will be cleaned with normal saline. A gauze pad (2" × 2") soaked in cold water with a temperature below 15 °C will be applied to the phlebitis site for 20 minutes. This will be done three times a day for three consecutive days. The cold water will be stored in the refrigerator in the respective wards one day prior to the dressing. It will be taken from the refrigerator just before the dressing and applied within one minute. After 20 minutes of application, the gauze pad for cold compress will be removed from the phlebitis site. From 1st to 3rd Day daily assessment done through VIP scale, will be conducted in both Group A (magnesium sulphate group) and Group B (cold compression group)

    Outcomes

    Primary Outcome Measures

    Reduction of phlebitis score
    magnesium sulphate and cold compression reduce the phlebitis score

    Secondary Outcome Measures

    Full Information

    First Posted
    October 2, 2023
    Last Updated
    October 2, 2023
    Sponsor
    University of Health Sciences Lahore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06072729
    Brief Title
    Comparison of Magnesium Sulphate Versus Cold Compress in IV Cannula Induces Phlebitis
    Official Title
    "Comparison of Magnesium Sulphate Versus Cold Compression on Patients With I.V Cannula Induce Phlebitis Admitted in Lahore General Hospital Lahore a Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    March 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Health Sciences Lahore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The use of intravenous (IV) devices is an integral part of patient care in hospitals, clinics, maternity home etc. approximately 80% of hospitalized patients receive I.V therapies. Phlebitis is a complication that is frequently associated with intravenous therapy. Phlebitis is the inflammation of a vein. It most commonly occurs in superficial veins. It is characterized by local pain, tenderness, swelling, induration, and erythema of the venous tract, and a palpable cord-like vein on the infusion site. The most common causes of phlebitis may be mechanical, chemical, and bacterial. Phlebitis may lead to life-threatening complications such as pain, Cellulitis, gangrene and it leads to amputation of the limb. The possibility of clot formation in the veins can lead to serious complications such as deep vein pulmonary embolism, which can cause sudden death. Other complications include septic shock, thrombophlebitis requiring supportive treatment, metastatic infection, the formation of liver abscesses, and endocarditis due to septic emboli. Patients with chronic diseases like diabetes, coronary heart disease, renal failure, hepatic encephalopathy, neurological conditions, and those who are bedridden for extended periods, as well as newborns, face difficulties in maintaining intravenous (IV) cannulas. As a result, needs to maintain central lines for fluids and medication, which is another source of infection. These complications can lead to prolonged hospital stays, increased medical costs, reduced patient satisfaction, and a lower quality of life for the affected individuals. Here the question arises for nurses to check the effectiveness of magnesium sulphate versus cold compress. To find the answer to this question this study will be conducted with the objective of comparing magnesium sulfate versus cold compression on patients with a peripheral intravenous cannula (PIVC) induced phlebitis, hospital-based comparative study and the simple random sampling technique will be used to collect a sample of sixty participants and will be equally distributed into two groups. The study will be conducted in Lahore general hospital Lahore Punjab Pakistan.
    Detailed Description
    Materials & Methods/Subjects & Methods: Study Design: • This study will be a Randomized Control Trial. Setting: This study will be carried out at the Institute of Nursing University of Health Sciences, Lahore in the collaboration with Lahore General Hospitals Lahore, Pakistan which is one of the major teaching hospitals and sample will be collected from Medical units, surgical units. Duration: The anticipated duration of this study will be 12 months. Sample Size: The sample size for each group is 35 calculated by using the following formula with estimated 80% power of the study, 95% confidence interval, and assuming that of phlebitis in group1: 96.70% and group 2 is 76.7% (Hongmei et al., 2020) (Sample size is calculated through the WHO online calculator) Sampling Technique: A total of 70 patients will be selected by simple random sampling. The patients will be randomized into two groups by lottery method. Group 1 (magnesium sulfate application) and Group 2 (cold compression) will be given. In this method, 70 cards having the same appearance will be used, 35 of them with letter 1 for group 1 and other letter 2 for group 2. Each participant should take one card from this box. Therefore random allocation of subjects will be determined (Dahal et al., 2020).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patient With IV Cannula Induce Phlebitis
    Keywords
    comparison, Magnesium Sulphate, Cold Compress, Phlebitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Magnesuuim Sulphate
    Arm Type
    Experimental
    Arm Description
    After the initial assessment, the cannula will be removed from the site (if present) the cannulation site will be cleaned with normal saline. A mixture of 100mg magnesium sulfate and glycerin will be applied to a gauze pad (2" × 2"). This gauze pad placed on the site of phlebitis induced by peripheral intravenous catheter (PIVC). This will be done three times a day for three consecutive days
    Arm Title
    Cold compression
    Arm Type
    Experimental
    Arm Description
    After the initial assessment, the cannula will be removed from the site (if present) and the area will be cleaned with normal saline. A gauze pad (2" × 2") soaked in cold water with a temperature below 15 °C will be applied to the phlebitis site for 20 minutes. This will be done three times a day for three consecutive days. The cold water will be stored in the refrigerator in the respective wards one day prior to the dressing. It will be taken from the refrigerator just before the dressing and applied within one minute. After 20 minutes of application, the gauze pad for cold compress will be removed from the phlebitis site. From 1st to 3rd Day daily assessment done through VIP scale, will be conducted in both Group A (magnesium sulphate group) and Group B (cold compression group)
    Intervention Type
    Other
    Intervention Name(s)
    comparison of magnesium sulphate versus cold compression
    Other Intervention Name(s)
    cold comprssion
    Intervention Description
    This study will involve a total of 70 participants who will be divided into two groups. One group will receive magnesium sulphate, while the other group will receive cold compression. The severity of phlebitis will be assessed in both groups using a visual phlebitis (VIP) rating scale.
    Primary Outcome Measure Information:
    Title
    Reduction of phlebitis score
    Description
    magnesium sulphate and cold compression reduce the phlebitis score
    Time Frame
    3 days 3 time a day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The patient admitted for 72 hours or more than 72 hours. Patient with intravenous therapy. Patients with signs of phlebitis 2-4 score on the VIP scale. Age group of 18-50 years and able to report pain. Exclusion Criteria: Patient with superficial thrombophlebitis and having skin disorder. Patient having associated muscular disorders like DVT, varicose veins,s, etc. Patient with disturbed coagulation profile. I.V Drug abusers
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nadia Manzoor, MS Nursing
    Phone
    +923351601100
    Email
    mishikhan.mishi.98@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zahida Parveen, MS Nursing
    Phone
    +923045427731
    Email
    zahidaperveen777@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison of Magnesium Sulphate Versus Cold Compress in IV Cannula Induces Phlebitis

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