Effect of Hypericum Perforatum Oil on Ecchymosis and Pain

NCT ID: NCT06367036

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-02

Study Completion Date

2023-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Ecchymosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Two researchers do not know which site was injected.

Study Groups

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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).

Group Type EXPERIMENTAL

Topical hypericum perforatum oil intervention

Intervention Type 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.

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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HATİCE DEMİRDAĞ

Assistant Proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurcan UYSAL, Associate Professor

Role: STUDY_CHAIR

Üsküdar University

Zehra KAMBER

Role: STUDY_CHAIR

Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital

Locations

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Hatice Demirdağ

Üsküdar, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2021-52

Identifier Type: -

Identifier Source: org_study_id

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