PainPhase 2/3NCT01645774
Comparing Pain and Bruising of Subcutaneous Heparin Injection
A Phase 2/3 study testing 10s injections duration, 10s injection duration and waiting 10s before withdrawing the needle and 15s injection duration and waiting 5s before withdrawing the needle in people with Pain and Bruising, run by Mashhad University of Medical Sciences.
Trial summary
Subcutaneous heparin injection is one of the most frequent nurses' clinical care. This study aimed to Identify and compare the effects of four different injection duration on pain and bruising associated with subcutaneous injection of heparin in 90 patients. Read more about this study
- Who is it for?
- Ages 53 to 69 years
- What is being tested?
- 10s injections duration, 10s injection duration and waiting 10s before withdrawing the needle and 15s injection duration and waiting 5s before withdrawing the needle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2012
- Phase
- Phase 2/3
- 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 53 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclination to participate in the study; filling out the form of conscious satisfaction
- Ability to answer the questions and determining the rate of pain
- Not being affected by blood clotting difficulties, tissue damages, injuries, and bruises in the site of injection.
Who cannot join
- Death,
- Discharge
About this study
Subcutaneous heparin injection is one of the most frequent nurses' clinical care. This study aimed to Identify and compare the effects of four different injection duration on pain and bruising associated with subcutaneous injection of heparin in 90 patients. Four injection methods were used for them:
A: 10s injections duration
Read more
B: 10s injection duration and waiting 10s before withdrawing the needle
C: 15s injection duration and waiting 5s before withdrawing the needle
D: 5s injection duration and waiting 15s before withdrawing the needle.
Bruising was measured by a flexible millimeter ruler 48h after each injection; and pain was measured by pain visual analogue scale immediately after the injection. Data will be analyzed by SPSS.
- Being tested
- 10s injections duration, 10s injection duration and waiting 10s before withdrawing the needle, 15s injection duration and waiting 5s before withdrawing the needle, 5s injection duration and waiting 15s before withdrawing the needle
- Keywords
- subcutaneous injection heparin, injection duration, bruising pain, decrease pain, decrease bruising
- Medical subject headings
- Pain, Contusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10s injections durationProcedure or surgery
10s injections duration
10s injection duration and waiting 10s before withdrawing the needleProcedure or surgery
10s injection duration and waiting 10s before withdrawing the needle
15s injection duration and waiting 5s before withdrawing the needleProcedure or surgery
15s injection duration and waiting 5s before withdrawing the needle
5s injection duration and waiting 15s before withdrawing the needleProcedure or surgery
5s injection duration and waiting 15s before withdrawing the needle
| Study group | Role | What they receive |
|---|---|---|
| 10s injections duration | Experimental | 10s injections duration Receives: Procedure: 10s injections duration |
| 10s injection duration , waiting 10s | Experimental | 10s injection duration and waiting 10s before withdrawing the needle Receives: Procedure: 10s injection duration and waiting 10s before withdrawing the needle |
| 15s injection duration,waiting 5s | Experimental | 15s injection duration and waiting 5s before withdrawing the needle Receives: Procedure: 15s injection duration and waiting 5s before withdrawing the needle |
| 5s injection duration , waiting 15s | Experimental | 5s injection duration and waiting 15s before withdrawing the needle Receives: Procedure: 5s injection duration and waiting 15s before withdrawing the needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease pain
pain was measured by pain visual analogue scale immediately after the injection.
Measured: up to 6 months
bruising
Bruising was measured by a flexible millimeter ruler 48h after each injection
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJun 2012
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tayebe Pourghaznein, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645774
- Sponsor's protocol ID
- interventional
- Status last verified
- Jun 2012
- First submitted
- 19 May 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Pain and Bruising of Subcutaneous Heparin Injection
- ClinicalTrials.gov ID
- NCT01645774
- Acronym / sponsor ID
- interventional
- Keywords
- subcutaneous injection heparin, injection duration, bruising pain, decrease pain, decrease bruising
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Jul 2012 (estimated)
- 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.
Subcutaneous heparin injection is one of the most frequent nurses' clinical care. This study aimed to Identify and compare the effects of four different injection duration on pain and bruising associated with subcutaneous injection of heparin in 90 patients. Four injection methods were used for them:
A: 10s injections duration
B: 10s injection duration and waiting 10s before withdrawing the needle
C: 15s injection duration and waiting 5s before withdrawing the needle
D: 5s injection duration and waiting 15s before withdrawing the needle.
Bruising was measured by a flexible millimeter ruler 48h after each injection; and pain was measured by pain visual analogue scale immediately after the injection. Data will be analyzed by SPSS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10s injections duration | Experimental | Procedure: 10s injections duration10s injections duration |
| 10s injection duration , waiting 10s | Experimental | Procedure: 10s injection duration and waiting 10s before withdrawing the needle10s injection duration and waiting 10s before withdrawing the needle |
| 15s injection duration,waiting 5s | Experimental | Procedure: 15s injection duration and waiting 5s before withdrawing the needle15s injection duration and waiting 5s before withdrawing the needle |
| 5s injection duration , waiting 15s | Experimental | Procedure: 5s injection duration and waiting 15s before withdrawing the needle5s injection duration and waiting 15s before withdrawing the needle |
Who may qualify
- Ages
- 53 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inclination to participate in the study; filling out the form of conscious satisfaction
- Ability to answer the questions and determining the rate of pain
- Not being affected by blood clotting difficulties, tissue damages, injuries, and bruises in the site of injection.
Key exclusion criteria (2 listed)
- Death,
- Discharge
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 |
|---|---|---|
| 10s injections duration10s injections duration | Procedure or surgery | 10s injections duration |
| 10s injection duration and waiting 10s before withdrawing the needle10s injection duration and waiting 10s before withdrawing the needle | Procedure or surgery | 10s injection duration , waiting 10s |
| 15s injection duration and waiting 5s before withdrawing the needle15s injection duration and waiting 5s before withdrawing the needle | Procedure or surgery | 15s injection duration,waiting 5s |
| 5s injection duration and waiting 15s before withdrawing the needle5s injection duration and waiting 15s before withdrawing the needle | Procedure or surgery | 5s injection duration , waiting 15s |
Primary outcome
decrease pain
Time frame: up to 6 months
pain was measured by pain visual analogue scale immediately after the injection.
bruising
Time frame: up to 6 months
Bruising was measured by a flexible millimeter ruler 48h after each injection
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
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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 Phase 2/3 study testing 10s injections duration, 10s injection duration and waiting 10s before withdrawing the needle and 15s injection duration and waiting 5s before withdrawing the needle in people with Pain and Bruising, run by Mashhad University of Medical Sciences.
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 3 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: stopped early, as of the sponsor's last update on 20 Jul 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
decrease pain (time frame: up to 6 months). 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 20 Jul 2012.