PainNCT06367036
Effect of Hypericum Perforatum Oil on Ecchymosis and Pain
A study testing Topical hypericum perforatum oil intervention in people with Pain and Ecchymosis, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Ecchymosis
- What is being tested?
- Topical hypericum perforatum oil intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Administration of haemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pain, Ecchymosis
- Being tested
- Topical hypericum perforatum oil intervention
- Keywords
- Hypericum Perforatum oil, low molecular weight heparin, subcutaneous injection, ecchymosis, pain
- Medical subject headings
- Pain, Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical hypericum perforatum oil interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypericum Perforatum Oil group | Experimental | 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). Receives: Other: Topical hypericum perforatum oil intervention |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start2 Jan 2022
- Primary completion29 Dec 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE DEMİRDAĞ, Uskudar University
- Investigators
- Nurcan UYSAL, Associate Professor, Study chair, Üsküdar UniversityZehra KAMBER, Study chair, Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367036
- Sponsor's protocol ID
- 2021-52
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared if necessary and requested.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypericum Perforatum Oil on Prevention Ecchymosis and Pain Associated With Subcutaneous Low Molecular Weight Heparin Injection: a Self-controlled Single-blind Study
- ClinicalTrials.gov ID
- NCT06367036
- Acronym / sponsor ID
- 2021-52
- Conditions
- Pain, Ecchymosis
- Keywords
- Hypericum Perforatum oil, low molecular weight heparin, subcutaneous injection, ecchymosis, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hypericum Perforatum Oil group | Experimental | Other: Topical hypericum perforatum oil interventionThis 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Administration of haemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical hypericum perforatum oil interventionThe 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. | Other | Hypericum Perforatum Oil group |
Primary outcome
Pain point
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No. It will be shared if necessary and requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurcan UYSAL, Associate Professor study chair
Üsküdar University
Zehra KAMBER study chair
Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical hypericum perforatum oil intervention in people with Pain and Ecchymosis, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain point (time frame: 48 hours after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.