PainShotblockerNCT05647239
The Effect of Shotblocker on Pain Violence and Injection Satisfaction
A study testing Shotblocker in people with Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of Shotblocker on pain level and injection satisfaction in SC injection administrations. The study was completed with 120 patients who were hospitalized in orthopedic clinic of a training and research hospital to receive treatment and met the inclusion criteria of the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Shotblocker
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2017to 5 Sep 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals whose treatment plan was Clexane 1x1 0.6 mg subcutaneous,
- Who were over 18 years of age,
- Who were conscious,
- Who had cognitive competence to answer the questionnaire,
- Who had no vision and hearing loss,
- Who had no bleeding clotting disorder,
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- Who had platelet, INR and APTT values within normal limits,
- Who had no signs of scar tissue, incision or infection in the injection site,
- Who had no allergy history and agreed to participate in the study were included in the study.
Who cannot join
- The patients, who had amputation in the right/left arm region to be injected,
- Who had any scar tissue, incision, lipodystrophy or infection symptom on the injection site in the arm area,
- Who received hemodialysis treatment and had dialysis catheter,
- Who underwent mastectomy surgery and should not receive any practice/treatment on the arm on the operated side, were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Shotblocker on Pain Violence and Injection Satisfaction in Subcutaneous Injectıon in Adults
This study was conducted to determine the effect of Shotblocker on pain level and injection satisfaction in SC injection administrations. The study was completed with 120 patients who were hospitalized in orthopedic clinic of a training and research hospital to receive treatment and met the inclusion criteria of the study. In addition to Standard practices for the clinic, the individuals in the intervention group received LMWH treatments via Shotblocker three times as once per day by administering SC from theside of the patients' upper armand thetreatment made with there ady injector of LMWH was ended within 20 seconds and the light pressure was applied to the injection site for 30 seconds. .
Read the detailed description
I Intervention Group: Before starting the application, the researcher informed the patients in the intervention group about the purpose of the study and their verbal and written informed consents were obtained.
The individuals to be included in the intervention and control groups were randomized by a faculty member at the Biostatistics Department of a university in the computer environment. The application was initiated by including the patients meeting the inclusion criteria on 04.12.2017. During the study, no intervention was made on the routine treatments of the patients in the intervention and control groups. Before the application, patient information form of each patient was filled using face-to-face interview technique.
Since the patients included in the study were discharged early (mean hospitalization duration was 3 days), the first, third and fifth SC heparin injection (0.6 ml) administrations were performed by the researcher for three days. The application was made to the arm area due to the fact that Shotblocker was difficult to place in the abdominal area, and the outer side of the arm was preferred for subcutaneous injection administrations in the clinic where the study was conducted. Shotblocker was placed on the injection site determined on the outer side of the upper arm of the patient and the injection was administered by gently pressing the tool with the fingertips during the injection. Shotblocker was removed after removal of the injector. Injections were completed in 20 seconds and the injection site was supported with cotton for 30 seconds. In the first minute after each SC injection application, the patients were asked about the pain level felt during the injection and the injection satisfaction status.
Control Group: Verbal and written informed consents of the patients included in the control group were obtained after they were informed by the researcher. Before the application, questions in patient information form were asked to each patient and how to use the VAS pain and injection satisfaction scale was explained. During injection, SC Clexan (0.6 ml) was injected on the site without using Shotblocker. Injections were completed in 20 seconds and the site was supported for 30 seconds. In the first minute after each SC injection administration, the patients were asked about pain level felt during the injection and injection satisfaction status.
In this study, the researcher administered all SC injections by throughout the study by considering the reliability of the study results.
- Conditions
- Pain
- Being tested
- Shotblocker
- Keywords
- Subcutaneous injection, Pain, ShotBlocker.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotblockerDevice
Shotblocker is a small plastic tool that can be used in all age groups in reducing pain due to injection, is non-medicinal, non-invasive, easy to use, and inexpensive and does not require material preparation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Since the patients included in the study were discharged early (mean hospitalization duration was 3 days), the first, third and fifth SC heparin injection (0.6 ml) administrations were performed by the researcher for three days. The application was made to the arm area due to the fact that Shotblocker was difficult to place in the abdominal area, and the outer side of the arm was preferred for subcutaneous injection administrations in the clinic where the study was conducted. Shotblocker was placed on the injection site determined on the outer side of the upper arm of the patient and the injection was administered by gently pressing the tool with the fingertips during the injection. Shotblocker was removed after removal of the injector. Injections were completed in 20 seconds and the injection site was supported with cotton for 30 seconds. Receives: Device: Shotblocker |
| Control | No intervention | Verbal and written informed consents of the patients included in the control group were obtained after they were informed by the researcher. Before the application, questions in patient information form were asked to each patient and how to use the VAS pain and injection satisfaction scale was explained. During injection, SC Clexan (0.6 ml) was injected on the site without using Shotblocker. Injections were completed in 20 seconds and the site was supported for 30 seconds. In the first minute after each SC injection administration, the patients were asked about pain level felt during the injection and injection satisfaction status. In this study, the researcher administered all SC injections by throughout the study by considering the reliability of the study results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level Measurement -Visual Analog Scale (VAS):
The scale developed by Priceet al., (1983) was used to evaluate the pain level perceived subjectively in many studies and found to be valid and reliable. The scale is composed of a 10-cm vertical or horizontal line starting with "no pain" and ending with "worst pain". The patient sare asked to indicate the severity of their pain by marking the appropriate point they see appropriate. The distance between the "no pain" starting point and this point is measured and recorded as "cm". The values range between 0 and 10 and the pain levels of patients are evaluated over 10 points as 0=no pain and 10=worst pain
Measured: Injections were completed in 20 seconds and the injection site was supported with cotton for 30 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start2 Apr 2017
- Primary completion1 May 2018
- Study completion5 Sep 2018
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.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Single group
- Model description
- The study was conducted in a randomized controlled study design in order to determine the effect of Shotblocker on pain and injection satisfaction in patients who were using DMAH and received subcutaneous injection after arthroplasty surgery in orthopedics training clinic.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil Şahin, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647239
- Sponsor's protocol ID
- 2017/400
- Acronym
- Shotblocker
- Status last verified
- Dec 2022
- First submitted
- 9 Sep 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shotblocker on Pain Violence and Injection Satisfaction in Subcutaneous Injectıon in Adults
- ClinicalTrials.gov ID
- NCT05647239
- Acronym / sponsor ID
- Shotblocker / 2017/400
- Conditions
- Pain
- Keywords
- Subcutaneous injection, Pain, ShotBlocker.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 2 Apr 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 12 Dec 2022 (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 was conducted to determine the effect of Shotblocker on pain level and injection satisfaction in SC injection administrations. The study was completed with 120 patients who were hospitalized in orthopedic clinic of a training and research hospital to receive treatment and met the inclusion criteria of the study. In addition to Standard practices for the clinic, the individuals in the intervention group received LMWH treatments via Shotblocker three times as once per day by administering SC from theside of the patients' upper armand thetreatment made with there ady injector of LMWH was ended within 20 seconds and the light pressure was applied to the injection site for 30 seconds. .
Detailed description
I Intervention Group: Before starting the application, the researcher informed the patients in the intervention group about the purpose of the study and their verbal and written informed consents were obtained.
The individuals to be included in the intervention and control groups were randomized by a faculty member at the Biostatistics Department of a university in the computer environment. The application was initiated by including the patients meeting the inclusion criteria on 04.12.2017. During the study, no intervention was made on the routine treatments of the patients in the intervention and control groups. Before the application, patient information form of each patient was filled using face-to-face interview technique.
Since the patients included in the study were discharged early (mean hospitalization duration was 3 days), the first, third and fifth SC heparin injection (0.6 ml) administrations were performed by the researcher for three days. The application was made to the arm area due to the fact that Shotblocker was difficult to place in the abdominal area, and the outer side of the arm was preferred for subcutaneous injection administrations in the clinic where the study was conducted. Shotblocker was placed on the injection site determined on the outer side of the upper arm of the patient and the injection was administered by gently pressing the tool with the fingertips during the injection. Shotblocker was removed after removal of the injector. Injections were completed in 20 seconds and the injection site was supported with cotton for 30 seconds. In the first minute after each SC injection application, the patients were asked about the pain level felt during the injection and the injection satisfaction status.
Control Group: Verbal and written informed consents of the patients included in the control group were obtained after they were informed by the researcher. Before the application, questions in patient information form were asked to each patient and how to use the VAS pain and injection satisfaction scale was explained. During injection, SC Clexan (0.6 ml) was injected on the site without using Shotblocker. Injections were completed in 20 seconds and the site was supported for 30 seconds. In the first minute after each SC injection administration, the patients were asked about pain level felt during the injection and injection satisfaction status.
In this study, the researcher administered all SC injections by throughout the study by considering the reliability of the study results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was conducted in a randomized controlled study design in order to determine the effect of Shotblocker on pain and injection satisfaction in patients who were using DMAH and received subcutaneous injection after arthroplasty surgery in orthopedics training clinic.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: ShotblockerSince the patients included in the study were discharged early (mean hospitalization duration was 3 days), the first, third and fifth SC heparin injection (0.6 ml) administrations were performed by the researcher for three days. The application was made to the arm area due to the fact that Shotblocker was difficult to place in the abdominal area, and the outer side of the arm was preferred for subcutaneous injection administrations in the clinic where the study was conducted. Shotblocker was placed on the injection site determined on the outer side of the upper arm of the patient and the injection was administered by gently pressing the tool with the fingertips during the injection. Shotblocker was removed after removal of the injector. Injections were completed in 20 seconds and the injection site was supported with cotton for 30 seconds. |
| Control | No intervention | –Verbal and written informed consents of the patients included in the control group were obtained after they were informed by the researcher. Before the application, questions in patient information form were asked to each patient and how to use the VAS pain and injection satisfaction scale was explained. During injection, SC Clexan (0.6 ml) was injected on the site without using Shotblocker. Injections were completed in 20 seconds and the site was supported for 30 seconds. In the first minute after each SC injection administration, the patients were asked about pain level felt during the injection and injection satisfaction status. In this study, the researcher administered all SC injections by throughout the study by considering the reliability of the study results. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Individuals whose treatment plan was Clexane 1x1 0.6 mg subcutaneous,
- Who were over 18 years of age,
- Who were conscious,
- Who had cognitive competence to answer the questionnaire,
- Who had no vision and hearing loss,
Key exclusion criteria (4 listed)
- The patients, who had amputation in the right/left arm region to be injected,
- Who had any scar tissue, incision, lipodystrophy or infection symptom on the injection site in the arm area,
- Who received hemodialysis treatment and had dialysis catheter,
- Who underwent mastectomy surgery and should not receive any practice/treatment on the arm on the operated side, were excluded from the 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 |
|---|---|---|
| ShotblockerShotblocker is a small plastic tool that can be used in all age groups in reducing pain due to injection, is non-medicinal, non-invasive, easy to use, and inexpensive and does not require material preparation | Device | Intervention |
Primary outcome
Pain Level Measurement -Visual Analog Scale (VAS):
Time frame: Injections were completed in 20 seconds and the injection site was supported with cotton for 30 seconds.
The scale developed by Priceet al., (1983) was used to evaluate the pain level perceived subjectively in many studies and found to be valid and reliable. The scale is composed of a 10-cm vertical or horizontal line starting with "no pain" and ending with "worst pain". The patient sare asked to indicate the severity of their pain by marking the appropriate point they see appropriate. The distance between the "no pain" starting point and this point is measured and recorded as "cm". The values range between 0 and 10 and the pain levels of patients are evaluated over 10 points as 0=no pain and 10=worst pain
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 12 Dec 2022.
- Individual participant dataSharing planned: No. there is no plan
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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 Shotblocker in people with Pain, run by TC Erciyes 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 9 inclusion and 4 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 12 Dec 2022. 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 Level Measurement -Visual Analog Scale (VAS): (time frame: Injections were completed in 20 seconds and the injection site was supported with cotton for 30 seconds.). 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 12 Dec 2022.