Injection Site ReactionNCT03645369
Effectiveness of Mechano-Analgesia and Cold Application on Ecchymosis, Pain and Satisfaction at Subcutaneous Heparin Injection
A study testing ShotBlocker and Ice pack in people with Injection Site Reaction and Injection Site Bruising, run by Istanbul Saglik Bilimleri University.
Trial summary
Fifty-five patients received three subcutaneous heparin injections (165 injections) by the same investigator using additional techniques such as mechano-analgesia and cold application, and without any additional techniques. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Injection Site Reaction, Injection Site Bruising
- What is being tested?
- ShotBlocker and Ice pack
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2015to 25 Dec 2015
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be older than 18 years
- Open to communication
- No complications during the operation
- Normal body mass index (BMI; reference range, 18.5-29.9 kg/m2) (d) and
- Platelet count (150.000-300.000)
- Give consent to participate in the study
Who cannot join
- Oral and parenteral anticoagulant treatment for at least 5 days
- Infection, scar tissue or incision, and parenteral treatment in their abdominal area
- Hematological and allergic disease
About this study
Official title: The Effectiveness of Mechano-Analgesia and Cold Application
Fifty-five patients received three subcutaneous heparin injections (165 injections) by the same investigator using additional techniques such as mechano-analgesia and cold application, and without any additional techniques.
Read the detailed description
The abdomen was divided into four quarters. The first, second, and third SC heparin injections were applied from the right abdominal region using ShotBlocker®, left abdominal region with an ice pack, and lower abdominal region without any additional application, respectively. All the injection sites were circled using a skin marking pen (r = 5 cm).
All the injections were administered following a standard procedure. Pain and satisfaction were assessed immediately after the injection by using the VAS score. Ecchymosis was assessed with an ecchymosis measurement tool at 48 and 60 hours after the injection (Figure 3).
- Conditions
- Injection Site Reaction, Injection Site Bruising
- Being tested
- ShotBlocker, Ice pack
- Keywords
- subcutaneous heparin, injection pain, ecchymosis
- Medical subject headings
- Injection Site Reaction, Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlockerDevice
ShotBlocker is a drug-free tool with no side effects and does not require preparation. It is a flexible, plastic, C-shaped device with a number of short (2 mm) blunt contact points on its back.
Ice packDevice
Ice pack containing gel
| Study group | Role | What they receive |
|---|---|---|
| Mechano-Analgesia | Experimental | The first SC heparin injections were applied from the right abdominal region using ShotBlocker®. Receives: Device: ShotBlocker |
| Cold Application | Experimental | The second SC heparin injections were applied from the left abdominal region with an ice pack Receives: Device: Ice pack |
| Control | No intervention | The second SC heparin injections were applied from the lower abdominal region without any additional application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measure via VAS
The VAS was used to measure pain intensity. The VAS was composed of a 10-cm long line, which had subjective descriptive expressions on both sides (0 cm: no pain and 10 cm: unbearable pain). The individual was asked to make a sign on the line indicating the degree of the pain. The numerical values were recorded by the researcher.
Measured: Immediately after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start2 Mar 2015
- Primary completion15 Mar 2015
- Study completion25 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injection Site ReactionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet İnangil, PhD, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645369
- Sponsor's protocol ID
- 108400987-67
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Celik N, Khorshid L. The Use of ShotBlocker for Reducing the Pain and Anxiety Associated With Intramuscular Injection: A Randomized, Placebo Controlled Study. Holist Nurs Pract. 2015 Sep-Oct;29(5):261-71. doi: 10.1097/HNP.0000000000000105.
PubMed 26263287
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Mechano-Analgesia and Cold Application
- ClinicalTrials.gov ID
- NCT03645369
- Acronym / sponsor ID
- 108400987-67
- Conditions
- Injection Site Reaction, Injection Site Bruising
- Keywords
- subcutaneous heparin, injection pain, ecchymosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 15 Mar 2015 (actual)
- Study completion
- 25 Dec 2015 (actual)
- First posted
- 24 Aug 2018 (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.
Fifty-five patients received three subcutaneous heparin injections (165 injections) by the same investigator using additional techniques such as mechano-analgesia and cold application, and without any additional techniques.
Detailed description
The abdomen was divided into four quarters. The first, second, and third SC heparin injections were applied from the right abdominal region using ShotBlocker®, left abdominal region with an ice pack, and lower abdominal region without any additional application, respectively. All the injection sites were circled using a skin marking pen (r = 5 cm).
All the injections were administered following a standard procedure. Pain and satisfaction were assessed immediately after the injection by using the VAS score. Ecchymosis was assessed with an ecchymosis measurement tool at 48 and 60 hours after the injection (Figure 3).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mechano-Analgesia | Experimental | Device: ShotBlockerThe first SC heparin injections were applied from the right abdominal region using ShotBlocker®. |
| Cold Application | Experimental | Device: Ice packThe second SC heparin injections were applied from the left abdominal region with an ice pack |
| Control | No intervention | –The second SC heparin injections were applied from the lower abdominal region without any additional application |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be older than 18 years
- Open to communication
- No complications during the operation
- Normal body mass index (BMI; reference range, 18.5-29.9 kg/m2) (d) and
- Platelet count (150.000-300.000)
Key exclusion criteria (3 listed)
- Oral and parenteral anticoagulant treatment for at least 5 days
- Infection, scar tissue or incision, and parenteral treatment in their abdominal area
- Hematological and allergic disease
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 |
|---|---|---|
| ShotBlockerShotBlocker is a drug-free tool with no side effects and does not require preparation. It is a flexible, plastic, C-shaped device with a number of short (2 mm) blunt contact points on its back. | Device | Mechano-Analgesia |
| Ice packIce pack containing gel | Device | Cold Application |
Primary outcome
Pain Intensity Measure via VAS
Time frame: Immediately after injection
The VAS was used to measure pain intensity. The VAS was composed of a 10-cm long line, which had subjective descriptive expressions on both sides (0 cm: no pain and 10 cm: unbearable pain). The individual was asked to make a sign on the line indicating the degree of the pain. The numerical values were recorded by the researcher.
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 24 Aug 2018.
- Results publication: PubMed 26263287Celik N, Khorshid L. The Use of ShotBlocker for Reducing the Pain and Anxiety Associated With Intramuscular Injection: A Randomized, Placebo Controlled Study. Holist Nurs Pract. 2015 Sep-Oct;29(5):261-71. doi: 10.1097/HNP.0000000000000105.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ShotBlocker and Ice pack in people with Injection Site Reaction and Injection Site Bruising, run by Istanbul Saglik Bilimleri 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 6 inclusion and 3 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 24 Aug 2018. 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?
Pain Intensity Measure via VAS (time frame: Immediately after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645369, which also lists 1 linked publication.
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 24 Aug 2018.