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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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30 April 2018 |
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Main ID: |
IRCT20100829004655N9 |
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Date of registration:
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2018-03-25 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of the effect Emla Cream? local lavender essential oil and Cold Compress on the pain intensity of the injection site and Comfort of heart Patients Receiving Enoxaparin
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Scientific title:
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Comparison of the effect Emla Cream? local lavender essential oil and Cold Compress on the pain intensity of the injection site and Comfort of heart Patients Receiving Enoxaparin |
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Date of first enrolment:
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2018-04-04 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://en.irct.ir/trial/29551 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling method is continuous The patients were randomly assigned to three intervention groups and one control group, Blinding description: patient and researcher measurement pain and comfort are blind.
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Phase:
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2
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Taghadosi Mohsen
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Address:
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Ghotb Ravandi Blvd, Kashan
8715988141
Kashan
Iran (Islamic Republic of) |
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Telephone:
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+98 36 1555 0021 |
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Email:
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taghadosi_m@kaums.ac.ir |
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Affiliation:
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Kashan University of Medical Sciences |
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Name:
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badry torki
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Address:
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Ghotb Ravandi Blvd, Kashan
87159/81151
Kashan
Iran (Islamic Republic of) |
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Telephone:
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+98 31 5554 0021 |
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Email:
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taghadosi_m@kaums.ac.ir |
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Affiliation:
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Kashan University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.age between 18-85 years old
full consciousness
ability to communicate
not a severe pain in other areas
no history of prescribed Enoxaparin
no scarring and lesions at the injection site
no history of allergy to lidocaine & Prilocain
no history of allergy to Lavender
Exclusion criteria: loss of consciousness
prescription of narcotic and non-narcotic analgesics 2 hours before injection
injection of other drug in the abdomen during the study
Age minimum:
18 years
Age maximum:
85 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Injection pain.
Other acute postprocedural pain
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G89.18
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Intervention(s)
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Intervention 1: First intervention group :In this method 1gr Emla cream is placed on the injection site with holder dressing 60 minute before the injection and dressing is removed after the one hour, then area is cleaned and injection is performed. Intervention 2: Second intervention group: In this method, a piece of ice the size of 3*2*2 Cm is placed inside the latex gloves and is placed on the injection site 5 minute before the injection. Intervention 3: Third intervention group:2 ml of lavender oil 10% will apply for 5 minutes before injection on the injection site and after 20 minutes, the skin will be cleaned and injected. Intervention 4: Control group:Enoxaparin injection without intervention.
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Primary Outcome(s)
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Injection pain. Timepoint: Immediate,5 &10 minute after injection. Method of measurement: Using the VAS scale & record severe pain intensity.
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The amount Patient comfort. Timepoint: Immediate,5 &10 minute after injection. Method of measurement: visual scale of comfor& record severe comfort intensity Using the.
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Source(s) of Monetary Support
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Kashan University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Kashan University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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