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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Ecchymosis
• Intervention / Treatment: Other: Topical hypericum perforatum oil intervention

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul
    • Üsküdar, İstanbul, Turkey, 34672
      • Hatice Demirdağ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypericum Perforatum Oil group; 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; 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.
No Intervention: Control group; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	48 hours after injection

Collaborators and Investigators

• Sponsor: Uskudar University
• Investigators: Study Chair: Nurcan UYSAL, Associate Professor, Uskudar University; Study Chair: Zehra KAMBER, Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Actual): December 29, 2022
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: April 6, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pain; ecchymosis; low molecular weight heparin; subcutaneous injection; Hypericum Perforatum oil
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders; Skin Manifestations; Ecchymosis
• Other Study ID Numbers: 2021-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will be shared if necessary and requested.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No