Effect of Hypericum Perforatum Oil on Ecchymosis and Pain

NCT06367036 — Not applicable, Completed, 160 participants, Uskudar University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Effect of Hypericum Perforatum Oil on Prevention Ecchymosis and Pain Associated With Subcutaneous Low Molecular Weight Heparin Injection: a Self-controlled Single-blind Study

Registry	NCT06367036
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, crossover, masking: single, prevention
Enrollment	160 (Actual)
Sponsor	Uskudar University (Other)
Conditions	Pain, Ecchymosis
Interventions	Topical hypericum perforatum oil intervention (Other)
Dates	start 2022-01-02, primary completion 2022-12-29, completion 2023-06-15, first posted 2024-04-16, last updated 2024-04-16
Locations	1 site in Turkey (Türkiye)

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Hypericum Perforatum Oil group	Experimental	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. 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).
Control group	No 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).

Topical hypericum perforatum oil intervention (Other): 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.

+Outcome measures

Primary outcomes

Pain point [48 hours after injection]: 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.
Ecchymosis [48 hours after injection]: 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.

+Eligibility

Sex: All

Inclusion Criteria:

* Over 18 years of age
* Normal platelet value,
* Normal international normalised ratio (INR) and prothrombin time (PTZ) values,
* No infection, scar tissue or incision in the lateral upper arm

Exclusion Criteria:

* Pregnancy
* Administration of haemodialysis

+Locations (1)

Facility	City	Country	Status
Hatice Demirdağ	Üsküdar, Istanbul	Turkey (Türkiye)

+Investigators

Nurcan UYSAL, Associate Professor, Study chair, Üsküdar University
Zehra KAMBER, Study chair, Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital