PainNCT06469112
The Effect of Vibration on Pain During Subcutaneous Heparin Injection
A study testing Vibration in people with Pain and Asthma, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this research will to examine the effect of the local vibration technique applied to the injection site during subcutaneous low molecular weight heparin (LMWH) injection. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Asthma, Pulmonary Disease
- What is being tested?
- Vibration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 14 May 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being over the age of 18
- having a doctor's prescription for subcutaneousheparin 0.6 mL treatment with a ready-to-use syringe and not yet having begun treatment
- having no coagulation disorder
- having no disorder which could affect pain perception,
- having no incision, lipodystrophy or finding of infection at the injection site,
- having no communication problem, and voluntarily agreeing to participate in the research
Who cannot join
- being under the age of 18
- having diabetes mellitus
- peripheral vascular disease, etc. which could affect the perception of pain
- not being conscious, refusing to participate in the research or opting to leave the study at any point.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vibration on Pain During Subcutaneous Heparin Injection: A Randomized Controlled Study
Aim: The aim of this research will to examine the effect of the local vibration technique applied to the injection site during subcutaneous low molecular weight heparin (LMWH) injection.
Methods: The patients will randomly assigned to an experimental (vibration) group , a placebo control group, and a nonintervention control group. Participants in the experimental group will give slight vibration to the injection site before the injection will administered; for participants in the placebo group, the device will placed on the injection site but with the vibration button kept switched off, while for the nonintervention control group, routine subcutaneous low molecular weight heparin injection will administered. The level of pain felt by the participants during the administration of the injection will assess with a visual analog scale.
- Conditions
- Pain, Asthma, Pulmonary Disease, Chest Disorder
- Being tested
- Vibration, Placebo
- Keywords
- Subcutaneous heparin injection, pain, non-pharmacological method, vibration
- Medical subject headings
- Pain, Asthma, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrationDevice
The device was used to provide vibration with the participants in this group. This device, designed as a combination of cold application and local vibration to reduce pain experienced during invasive procedures, is frequently chosen for all age groups.
PlaceboOther
The device was used with participants in this group. The device, at room temperature, was placed by the researcher 5cm proximal to the injection site before the injection was performed. With participants in this group, the device was placed on the procedure site, but no vibration was made. The device was held on the participants for one minute before the injection and throughout the procedure, with the vibration switched off.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Vibration Application Group | Experimental | With individuals in this group, device will be used to provide vibration. This device, designed as a combination of cold application and local vibration to reduce pain experienced during invasive procedures, is frequently chosen for all age groups. There is a motor in the body which provides vibration. The device also has ice wings behind the body, which are used to provide cold, but these will not used in this research.
The device, at room temperature, was placed by the researcher 5 cm proximal to the injection site before the injection will performed. For one minute before the injection, a slight non-discomforting vibration will make, and this will be continue while the injection was given. In this study, only the body of the device will be used to provide vibration. Receives: Device: Vibration |
| Placebo: Intervention Control Group | Placebo comparator | The device was used with participants in this group. The device, at room temperature, was placed by the researcher 5 cm proximal to the injection site before the injection was performed. With participants in this group, the device was placed on the procedure site, but no vibration was made. The device was held on the participants for one minute before the injection and throughout the procedure, with the vibration switched off. Receives: Other: Placebo |
| Control: Nonintervention Group | No intervention | No intervention was performed before or during the procedure with the participants in the control group, and the standard subcutaneous heparin injection procedure was carried out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity in mm
A 10-cm vertical VAS will used to evaluate the severity of pain felt by the individuals during the procedure. One end indicated lack of pain and the other the most severe pain possible.
Measured: 6 months
Secondary outcomes (2)
weight
weight in kilograms
Measured: 6 months
height
height in meters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Dec 2023
- Primary completion14 May 2024
- Study completion14 May 2024
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yilmaz, PhD, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469112
- Sponsor's protocol ID
- 2023-28/1
- Status last verified
- Jan 2025
- First submitted
- 16 Jun 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vibration on Pain During Subcutaneous Heparin Injection: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06469112
- Acronym / sponsor ID
- 2023-28/1
- Conditions
- Pain, Asthma, Pulmonary Disease, Chest Disorder
- Keywords
- Subcutaneous heparin injection, pain, non-pharmacological method, vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 21 Jun 2024 (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.
Aim: The aim of this research will to examine the effect of the local vibration technique applied to the injection site during subcutaneous low molecular weight heparin (LMWH) injection.
Methods: The patients will randomly assigned to an experimental (vibration) group , a placebo control group, and a nonintervention control group. Participants in the experimental group will give slight vibration to the injection site before the injection will administered; for participants in the placebo group, the device will placed on the injection site but with the vibration button kept switched off, while for the nonintervention control group, routine subcutaneous low molecular weight heparin injection will administered. The level of pain felt by the participants during the administration of the injection will assess with a visual analog scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Vibration Application Group | Experimental | Device: VibrationWith individuals in this group, device will be used to provide vibration. This device, designed as a combination of cold application and local vibration to reduce pain experienced during invasive procedures, is frequently chosen for all age groups. There is a motor in the body which provides vibration. The device also has ice wings behind the body, which are used to provide cold, but these will not used in this research. The device, at room temperature, was placed by the researcher 5 cm proximal to the injection site before the injection will performed. For one minute before the injection, a slight non-discomforting vibration will make, and this will be continue while the injection was given. In this study, only the body of the device will be used to provide vibration. |
| Placebo: Intervention Control Group | Placebo comparator | Other: PlaceboThe device was used with participants in this group. The device, at room temperature, was placed by the researcher 5 cm proximal to the injection site before the injection was performed. With participants in this group, the device was placed on the procedure site, but no vibration was made. The device was held on the participants for one minute before the injection and throughout the procedure, with the vibration switched off. |
| Control: Nonintervention Group | No intervention | –No intervention was performed before or during the procedure with the participants in the control group, and the standard subcutaneous heparin injection procedure was carried out. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being over the age of 18
- having a doctor's prescription for subcutaneousheparin 0.6 mL treatment with a ready-to-use syringe and not yet having begun treatment
- having no coagulation disorder
- having no disorder which could affect pain perception,
- having no incision, lipodystrophy or finding of infection at the injection site,
Key exclusion criteria (4 listed)
- being under the age of 18
- having diabetes mellitus
- peripheral vascular disease, etc. which could affect the perception of pain
- not being conscious, refusing to participate in the research or opting to leave the study at any point.
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 |
|---|---|---|
| VibrationThe device was used to provide vibration with the participants in this group. This device, designed as a combination of cold application and local vibration to reduce pain experienced during invasive procedures, is frequently chosen for all age groups. | Device | Experimental: Vibration Application Group |
| PlaceboThe device was used with participants in this group. The device, at room temperature, was placed by the researcher 5cm proximal to the injection site before the injection was performed. With participants in this group, the device was placed on the procedure site, but no vibration was made. The device was held on the participants for one minute before the injection and throughout the procedure, with the vibration switched off. | Other | Placebo: Intervention Control Group |
Primary outcome
pain intensity in mm
Time frame: 6 months
A 10-cm vertical VAS will used to evaluate the severity of pain felt by the individuals during the procedure. One end indicated lack of pain and the other the most severe pain possible.
2 secondary outcomes
weight
Time frame: 6 months
height
Time frame: 6 months
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 6 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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 Vibration in people with Pain and Asthma, run by Uludag 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 6 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 6 Apr 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. Some participants in this study may receive a placebo. 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 in mm (time frame: 6 months). 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 6 Apr 2025.