Pain, AcuteNCT06829407
Effect of Different Subcutaneous Injection Methods on Pain and Satisfaction
A study testing injection time, palm stimulator and injection time and palm stimulator in people with Pain, Acute and Injection Site, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
This study; In patients treated with subcutaneous heparin A randomized controlled trial was planned to determine the effect of the injection time and the device called "Palm Stimulator" to reduce the pain felt during injection. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Injection Site
- What is being tested?
- injection time, palm stimulator and injection time and palm stimulator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2024to 23 Sep 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years old
- The one who is literate,
- No physical, mental disabilities or communication difficulties,
- Low Molecular Weight Heparin in the treatment plan,
- No history of allergy,
- Agreeing to participate in the research,
- There is no scar tissue, incision or infection in the area to be injected,
- Patients who will receive a 1-day injection and whose pain score is between 1-10 according to VAS will be admitted.
Who cannot join
- Who gave up participating in the research while continuing the research,
- Using subcutaneous insulin therapy,
- There is an amputation in the right/left arm area where the study will be performed,
- There is scar tissue, incision or signs of infection in the area to be injected,
- Patients who received injections for 1 day and whose pain score is 0 (zero) according to VAS will not be admitted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Different Methods Used in Subcutaneous Heparin Injections on Pain and Satisfaction
This study; In patients treated with subcutaneous heparin A randomized controlled trial was planned to determine the effect of the injection time and the device called "Palm Stimulator" to reduce the pain felt during injection.
- Conditions
- Pain, Acute, Injection Site
- Being tested
- injection time, palm stimulator, injection time and palm stimulator
- Keywords
- pain, low molecular weight heparin, palm stimulator, extended injection time
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection timeOther
give an injection
palm stimulatorOther
give an injection
injection time and palm stimulatorOther
give an injection
| Study group | Role | What they receive |
|---|---|---|
| injection time | Experimental | The application will be done by injecting for 30 seconds and then waiting for 10 seconds and ending the process. Receives: Other: injection time |
| palm stimulator | Experimental | By ensuring that the patient grasps the "palm stimulator" equipment in the palm during the injection and squeezes it in the palm throughout the injection. Tactile warning will be given. However, the injection process will last 10 seconds and the process will be terminated after waiting 10 seconds. Receives: Other: palm stimulator |
| injection time and palm stimulator | Experimental | Injection will be done for 30 seconds and then waited for 10 seconds and the process will be terminated, and the application will be done using equipment. Receives: Other: injection time and palm stimulator |
| control group | No intervention | The injection process will last 10 seconds and the process will be terminated after waiting 10 seconds. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale Patient Identification Form
Patient Identification Form
It was prepared by researchers by examining the literature on the subject. This form includes 5 questions that include some sociodemographic characteristics of the individual (age, gender, marital status, education status, employment status, etc.) and 8 questions that include characteristics related to health, illness and treatment (presence of chronic disease, body mass index, etc.).
Measured: during injection procedure
Visual Scale for pain
Visual comparison scale for pain The scale consists of a single item, the scale is formed by a 10 cm long line on the horizontal plane. The leftmost side of the line (starting point) is scored as 0 (zero) and the rightmost side (ending point) is scored as 10 (ten) points for the highest possible pain. In order for the patient to score the pain, he/she is asked to mark a point on the line during the injection process. After marking, the distance from the starting point to the marked place is measured and the score is formed. The scale has been proven to be reliable in terms of Turkish as a result of the study conducted by Yaray et al.
Measured: during injection procedure
Visual Comparison Scale for Satisfaction
Visual Comparison Scale for Satisfaction In this scale, scores between 0 and 10 were used to determine satisfaction levels. A score of 0 represented the least satisfaction level, while a score of 10 represented the highest satisfaction level. The Visual Analog Scale was used so that patients could express both their pain and satisfaction levels.
Measured: during injection procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start20 Aug 2024
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- this study is an experimental, parallel-group (intervention-control), randomized controlled design
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Umit Yilmaz, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829407
- Sponsor's protocol ID
- TUTF-GOBAEK 202313|8
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Methods Used in Subcutaneous Heparin Injections on Pain and Satisfaction
- ClinicalTrials.gov ID
- NCT06829407
- Acronym / sponsor ID
- TUTF-GOBAEK 202313|8
- Conditions
- Pain, Acute, Injection Site
- Keywords
- pain, low molecular weight heparin, palm stimulator, extended injection time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 17 Feb 2025 (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.
This study; In patients treated with subcutaneous heparin A randomized controlled trial was planned to determine the effect of the injection time and the device called "Palm Stimulator" to reduce the pain felt during injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- this study is an experimental, parallel-group (intervention-control), randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| injection time | Experimental | Other: injection timeThe application will be done by injecting for 30 seconds and then waiting for 10 seconds and ending the process. |
| palm stimulator | Experimental | Other: palm stimulatorBy ensuring that the patient grasps the "palm stimulator" equipment in the palm during the injection and squeezes it in the palm throughout the injection. Tactile warning will be given. However, the injection process will last 10 seconds and the process will be terminated after waiting 10 seconds. |
| injection time and palm stimulator | Experimental | Other: injection time and palm stimulatorInjection will be done for 30 seconds and then waited for 10 seconds and the process will be terminated, and the application will be done using equipment. |
| control group | No intervention | –The injection process will last 10 seconds and the process will be terminated after waiting 10 seconds. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Above 18 years old
- The one who is literate,
- No physical, mental disabilities or communication difficulties,
- Low Molecular Weight Heparin in the treatment plan,
- No history of allergy,
Key exclusion criteria (5 listed)
- Who gave up participating in the research while continuing the research,
- Using subcutaneous insulin therapy,
- There is an amputation in the right/left arm area where the study will be performed,
- There is scar tissue, incision or signs of infection in the area to be injected,
- Patients who received injections for 1 day and whose pain score is 0 (zero) according to VAS will not be admitted.
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 |
|---|---|---|
| injection timegive an injection | Other | injection time |
| palm stimulatorgive an injection | Other | palm stimulator |
| injection time and palm stimulatorgive an injection | Other | injection time and palm stimulator |
Primary outcome
Scale Patient Identification Form
Time frame: during injection procedure
Patient Identification Form It was prepared by researchers by examining the literature on the subject. This form includes 5 questions that include some sociodemographic characteristics of the individual (age, gender, marital status, education status, employment status, etc.) and 8 questions that include characteristics related to health, illness and treatment (presence of chronic disease, body mass index, etc.).
Visual Scale for pain
Time frame: during injection procedure
Visual comparison scale for pain The scale consists of a single item, the scale is formed by a 10 cm long line on the horizontal plane. The leftmost side of the line (starting point) is scored as 0 (zero) and the rightmost side (ending point) is scored as 10 (ten) points for the highest possible pain. In order for the patient to score the pain, he/she is asked to mark a point on the line during the injection process. After marking, the distance from the starting point to the marked place is measured and the score is formed. The scale has been proven to be reliable in terms of Turkish as a result of the study conducted by Yaray et al.
Visual Comparison Scale for Satisfaction
Time frame: during injection procedure
Visual Comparison Scale for Satisfaction In this scale, scores between 0 and 10 were used to determine satisfaction levels. A score of 0 represented the least satisfaction level, while a score of 10 represented the highest satisfaction level. The Visual Analog Scale was used so that patients could express both their pain and satisfaction levels.
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 17 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection time, palm stimulator and injection time and palm stimulator in people with Pain, Acute and Injection Site, run by Trakya 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 8 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 17 Feb 2025. 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?
Scale Patient Identification Form (time frame: during injection procedure). 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 17 Feb 2025.