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Effect of Hypericum Perforatum Oil on Ecchymosis and Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06367036
Enrollment
160
Registered
2024-04-16
Start date
2022-01-02
Completion date
2023-06-15
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ecchymosis, Pain

Keywords

Hypericum Perforatum oil, low molecular weight heparin, subcutaneous injection, ecchymosis, pain

Brief 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.

Interventions

OTHERTopical hypericum perforatum oil intervention

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.

Sponsors

Uskudar University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

Two researchers do not know which site was injected.

Intervention model description

There is no control group in this research design. The participants themselves are also the control group. Intervention was applied to one injection site of the participants 2 hours before the injection and not to the other. Post-injection pain and ecchymosis were evaluated for both sites. The two researchers who analyzed the results do not know the region where the intervention was applied.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain point48 hours after injectionThe 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.
Ecchymosis48 hours after injectionEcchymosis 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026