Injection Site BruisingNCT05771285
Cold Application on the Subcutaneous Injection
A study testing Cold application in people with Injection Site Bruising and Bruising, run by Yuksek Ihtisas University.
Trial summary
The goal of this clinical trial is to compare the effect of cold application at different periods of time on the occurrence of bruising, haematoma and pain in the subcutaneous low molecular weight heparin (LMWH) injected patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injection Site Bruising, Bruising, Pain
- What is being tested?
- Cold application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to receive LMWH (pre-filled syringe containing 40 mg enoxaparin sodium in 0.4 ml) treatment at least once a day
- not to have any visual or auditory disorders
- not to have any foreknown coagulation disorders
- to have platelet, PTT and international normalized ratio (INR) values within the normal limits for beginning enoxaparin sodium injections
- not to have any hematologic disorders or any bruising or injuries at the abdominal wall
- to receive no injections at the abdominal site, other than the enoxaparin sodium during the research protocol
- to will to participate in this study
Who cannot join
- to be pregnant
- have bleeding in the injection site
- have pain at any site of their body prior to the injection
- have any incision, drain, scar tissue, lipodystrophy or infection symptoms at the abdominal site which hinder the application of injection
- not to will to participate in this study
About this study
Official title: The Effect of Cold Application on the Occurrence of Bruising, Hematoma and Pain in the Subcutaneous Low Molecular Weight Heparin Injection: a Randomized Controlled Trial
The goal of this clinical trial is to compare the effect of cold application at different periods of time on the occurrence of bruising, haematoma and pain in the subcutaneous low molecular weight heparin (LMWH) injected patients.
Read the detailed description
The study was a single-blind randomised control trial. Patients were allocated randomly to three groups: (i) Cold was applied for two minutes before the injection in the first group (n=26); (ii) Cold was applied for 5 min before the injection in the second group (n=26); and (iii) control group (n=26). All participating patients were injected 40 mg enoxaparin sodium in 0.4 ml in the pre-filled syringes using standard LMWH injection protocol. Post-injection VAS (Visual Analogue Scale) assessment and assessment of the presence and size of bruise and haematoma were conducted at 48th and 72nd hours after the injections for all groups.
- Conditions
- Injection Site Bruising, Bruising, Pain
- Being tested
- Cold application
- Keywords
- bruising, cold application, haematoma, low molecular weight heparin, nursing, pain, subcutaneous injection
- Medical subject headings
- Contusions, Pain, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold applicationOther
To evaluate the effect of cold application applied before subcutaneous low molecular weight heparin injection on post-injection pain, ecchymosis and hematoma formation.
| Study group | Role | What they receive |
|---|---|---|
| Group with two-minute pre-injection application of cold | Active comparator | Before applying the subcutaneous injection, cold application pack was applied on the injection site for two minutes. Then, the low molecular weight heparin injection was applied to this cold-applied area in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours. Receives: Other: Cold application |
| Group with five-minute pre-injection application of cold | Active comparator | Before applying the subcutaneous injection, cold application pack was applied on the injection site for five minutes. Then, the low molecular weight heparin injection was applied to this cold-applied area in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours. Receives: Other: Cold application |
| Control group | No intervention | Without applying any tools or processes, the low molecular weight heparin injection was applied in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare of the bruise occurrence change at 48th and 72nd hours after the heparin injection.
It was evaluated whether bruise occurred 2 times at 48th and 72nd hours after heparin injection.
Measured: after 48th and 72nd hours from injection
Compare of the bruise sizes change of the patients at 48th and 72nd hours.
If bruise developed after heparin injection, its size was measured 2 times at 48th and 72nd hours and recorded.
Measured: after 48th and 72nd hours from injection
Compare of the Visual Analogue Scale pain scores of the patients
The level of pain felt after the heparin injection administration was measured with the visual analogue scale. Visual Analogue Scale (VAS) was used to measure the extent of pain during the injection. VAS is widely used to measure the clinical symptoms such as pain, panic, depression, and fatigue. VAS consists of 100 mm on a horizontal line. On the scale "0" means no pain and "100" shows severe pain. The patients were asked to mark the extent of pain they had immediately after the subcutaneous injection on the scale with 'X'. The distance from "no pain" to the place that the patient has marked quantitatively represents the pain of the patient.
Measured: after 1 minute from injection administration
Secondary outcomes (1)
Occurrence of haematoma at 48th and 72nd hours after the heparin injection.
Changes in hematoma formation were evaluated at 48 and 72 hours after heparin injection.
Measured: after 48th and 72nd hours from injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study startJan 2017
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site BruisingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, cevahir ilkim buldak, Yuksek Ihtisas University
- Investigators
- Cevahir İlkim BULDAK, Principal investigator, ilkimbuldak@yiu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771285
- Sponsor's protocol ID
- Cold App
- Status last verified
- Mar 2023
- First submitted
- 22 Dec 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Application on the Occurrence of Bruising, Hematoma and Pain in the Subcutaneous Low Molecular Weight Heparin Injection: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05771285
- Acronym / sponsor ID
- Cold App
- Conditions
- Injection Site Bruising, Bruising, Pain
- Keywords
- bruising, cold application, haematoma, low molecular weight heparin, nursing, pain, subcutaneous injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Mar 2023 (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.
The goal of this clinical trial is to compare the effect of cold application at different periods of time on the occurrence of bruising, haematoma and pain in the subcutaneous low molecular weight heparin (LMWH) injected patients.
Detailed description
The study was a single-blind randomised control trial. Patients were allocated randomly to three groups: (i) Cold was applied for two minutes before the injection in the first group (n=26); (ii) Cold was applied for 5 min before the injection in the second group (n=26); and (iii) control group (n=26). All participating patients were injected 40 mg enoxaparin sodium in 0.4 ml in the pre-filled syringes using standard LMWH injection protocol. Post-injection VAS (Visual Analogue Scale) assessment and assessment of the presence and size of bruise and haematoma were conducted at 48th and 72nd hours after the injections for all groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group with two-minute pre-injection application of cold | Active comparator | Other: Cold applicationBefore applying the subcutaneous injection, cold application pack was applied on the injection site for two minutes. Then, the low molecular weight heparin injection was applied to this cold-applied area in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours. |
| Group with five-minute pre-injection application of cold | Active comparator | Other: Cold applicationBefore applying the subcutaneous injection, cold application pack was applied on the injection site for five minutes. Then, the low molecular weight heparin injection was applied to this cold-applied area in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours. |
| Control group | No intervention | –Without applying any tools or processes, the low molecular weight heparin injection was applied in accordance with the subcutaneous heparin injection protocol. VAS assessment was made after the injection and bruise and haematoma assessments were conducted after 48 and 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- to receive LMWH (pre-filled syringe containing 40 mg enoxaparin sodium in 0.4 ml) treatment at least once a day
- not to have any visual or auditory disorders
- not to have any foreknown coagulation disorders
- to have platelet, PTT and international normalized ratio (INR) values within the normal limits for beginning enoxaparin sodium injections
- not to have any hematologic disorders or any bruising or injuries at the abdominal wall
Key exclusion criteria (5 listed)
- to be pregnant
- have bleeding in the injection site
- have pain at any site of their body prior to the injection
- have any incision, drain, scar tissue, lipodystrophy or infection symptoms at the abdominal site which hinder the application of injection
- not to will to participate in this study
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 |
|---|---|---|
| Cold applicationTo evaluate the effect of cold application applied before subcutaneous low molecular weight heparin injection on post-injection pain, ecchymosis and hematoma formation. | Other | Group with five-minute pre-injection application of cold, Group with two-minute pre-injection application of cold |
Primary outcome
Compare of the bruise occurrence change at 48th and 72nd hours after the heparin injection.
Time frame: after 48th and 72nd hours from injection
It was evaluated whether bruise occurred 2 times at 48th and 72nd hours after heparin injection.
Compare of the bruise sizes change of the patients at 48th and 72nd hours.
Time frame: after 48th and 72nd hours from injection
If bruise developed after heparin injection, its size was measured 2 times at 48th and 72nd hours and recorded.
Compare of the Visual Analogue Scale pain scores of the patients
Time frame: after 1 minute from injection administration
The level of pain felt after the heparin injection administration was measured with the visual analogue scale. Visual Analogue Scale (VAS) was used to measure the extent of pain during the injection. VAS is widely used to measure the clinical symptoms such as pain, panic, depression, and fatigue. VAS consists of 100 mm on a horizontal line. On the scale "0" means no pain and "100" shows severe pain. The patients were asked to mark the extent of pain they had immediately after the subcutaneous injection on the scale with 'X'. The distance from "no pain" to the place that the patient has marked quantitatively represents the pain of the patient.
1 secondary outcome
Occurrence of haematoma at 48th and 72nd hours after the heparin injection.
Time frame: after 48th and 72nd hours from injection
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 Mar 2023.
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.
Cevahir İlkim BULDAK principal investigator
ilkimbuldak@yiu.edu.tr
Questions about this trial
What is this clinical trial studying?
A study testing Cold application in people with Injection Site Bruising and Bruising, run by Yuksek Ihtisas University.
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 7 inclusion and 5 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Compare of the bruise occurrence change at 48th and 72nd hours after the heparin injection. (time frame: after 48th and 72nd hours from injection). The study lists 3 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 Mar 2023.