Patient With IV Cannula Induce PhlebitisNCT06072729
Comparison of Magnesium Sulphate Versus Cold Compress in IV Cannula Induces Phlebitis
A study testing comparison of magnesium sulphate versus cold compression in people with Patient With IV Cannula Induce Phlebitis, run by University of Health Sciences Lahore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient With IV Cannula Induce Phlebitis
- What is being tested?
- comparison of magnesium sulphate versus cold compression
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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).
- Conditions
- Patient With IV Cannula Induce Phlebitis
- Being tested
- comparison of magnesium sulphate versus cold compression
- Keywords
- comparison, Magnesium Sulphate, Cold Compress, Phlebitis
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of magnesium sulphate versus cold compressionOther
Also called cold comprssion
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.
| Study group | Role | What they receive |
|---|---|---|
| Magnesuuim Sulphate | Experimental | 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 Receives: Other: comparison of magnesium sulphate versus cold compression |
| Cold compression | Experimental | 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) Receives: Other: comparison of magnesium sulphate versus cold compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of phlebitis score
magnesium sulphate and cold compression reduce the phlebitis score
Measured: 3 days 3 time a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Sep 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With IV Cannula Induce PhlebitisStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Manzoor, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072729
- Sponsor's protocol ID
- Cold compression 1507
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06072729
- Acronym / sponsor ID
- Cold compression 1507
- Conditions
- Patient With IV Cannula Induce Phlebitis
- Keywords
- comparison, Magnesium Sulphate, Cold Compress, Phlebitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesuuim Sulphate | Experimental | Other: comparison of magnesium sulphate versus cold compressionAfter 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 |
| Cold compression | Experimental | Other: comparison of magnesium sulphate versus cold compressionAfter 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparison of magnesium sulphate versus cold compressionAlso: cold comprssionThis 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. | Other | Cold compression, Magnesuuim Sulphate |
Primary outcome
Reduction of phlebitis score
Time frame: 3 days 3 time a day
magnesium sulphate and cold compression reduce the phlebitis score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing comparison of magnesium sulphate versus cold compression in people with Patient With IV Cannula Induce Phlebitis, run by University of Health Sciences Lahore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia Manzoor, MS Nursing (+923351601100, mishikhan.mishi.98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of phlebitis score (time frame: 3 days 3 time a day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.