An interventional study of Topical hypericum perforatum oil intervention in Pain and Ecchymosis, sponsored by Uskudar University. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Uskudar University · Not applicable, Interventional, and Prevention
Low molecular weight heparin is a drug with anticoagulant and antithrombotic effects. This drug is frequently administered subcutaneously to patients by nurses. Complications such as pain, ecchymosis and hematoma may commonly occur at the injection site. This study investigated the effect of Hypericum Perforatum oil in preventing pain and ecchymosis after subcutaneous injection low molecular weight heparin. This quasi-experimental and single blinded study was conducted with 160 patients in a coronary intensive care unit. The researcher nurse applied 5-6 drops of Hypericum Perforatum oil to one arm of the patients 2 hours before the injection. The other arm of the patient was considered as the control arm. A total of 320 injections were administered. The evaluation of the injection sites was performed by two other researchers at 48th hours. The data were analyzed using Wilcoxon and McNemar test.
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This study's enrollment of 160 is above the median of 66 across 8,493 interventional studies indexed under Pain.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This research is a self-controlled study. One injected arm of the patient will be assigned to the intervention group and the other arm to the control group. İn the experimental arm, the research nurse working in the Coronary Intensive Care unit (CICU) applied 5-6 drops of HP oil on one arm of the patient with a patting motion 2 hours before the injection. The area was left open for the oil to be absorbed. Only this nurse who administered the injection knows on which arm the oil was applied. The assessment of ecchymosis and pain at the injection site was performed by two other investigators at the 48th hour of the injection (Single blind).
Other: Topical hypericum perforatum oil intervention
This research is a self-controlled study. One injected arm of the patient will be assigned to the intervention group and the other arm to the control group.In the control arm, no treatment was performed before injection.The assessment of ecchymosis and pain at the injection site was performed by two other investigators at the 48th hour of the injection (Single blind).
The research nurse working in the CICU applied 5-6 drops of hypericum perforatum oil on one arm of the patient with a patting motion 2 hours before the injection. The area was left open for the oil to be absorbed. Only this nurse who administered the injection knows on which arm the oil was applied.
Pain point
The patient's pain was evaluated with Visual Analogue Scale (VAS) 48 hours after the injection. Visual Analogue Scale is a reliable pain assessment scale to determine the pain felt by patients at the injection site. The VAS is a self-report scale consisting of a horizontal line (10 cm long) with anchor points "no pain" and "worst possible pain". The patient is asked to mark the place on this line that best describes the intensity of pain. A marking of "0" means "no pain". Marking "10" means "'intolerable pain". In this way, the patient scores his/her pain between 1-10.
Time frame: 48 hours after injection
Ecchymosis
Ecchymosis was evaluated at 48th hours after injection in the study. A transparent ruler that allows millimetric measurement was used to measure the ecchymosis at the injection site. The discoloration at the injection site was measured in millimeter. Ecchymosis was defined as an area of discolored skin of more than 2 mm appearing 48th hours after administration. The maximum horizontal extent (diameter) of the bruise was recorded regardless of whether the bruise was regular or uneven in shape at the time of measurement. According to previous studies, bruise size was analyzed according to 3 categories: no bruise (0-1 mm), small bruise (2-5 mm) and large bruise (\>5 mm). In our study, bruises \>2 mm in size was accepted as ecchymosis.
Time frame: 48 hours after injection
Plan to share: No — It will be shared if necessary and requested.
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