Injection Site PainNCT07860099
The Effect of the Cold Needle Technique on Pain and Patient Satisfaction Levels During Intramuscular Injection Administered to the Ventrogluteal Site
A study testing Cold Needle Technique and Standard Intramuscular Injection in people with Injection Site Pain, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of the cold needle technique on pain and patient satisfaction during intramuscular injections administered to the ventrogluteal site. The study was conducted in the internal medicine clinics of Prof. Dr. Cemil Taşçıoğlu City Hospital in Istanbul, Türkiye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injection Site Pain
- What is being tested?
- Cold Needle Technique and Standard Intramuscular Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2025to 1 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Receiving a prescribed intramuscular vitamin B12 injection.
- No cognitive impairment.
- Able to communicate effectively.
- Willing to participate in the study and provide informed consent.
Who cannot join
- Presence of a skin disease or infection at the injection site.
- Diagnosis of a neurological or psychiatric disorder.
- History of opioid use that may affect pain perception.
- Diagnosis of diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascioglu City Hospital
Istanbul, Istanbul, 34384
About this study
This randomized controlled trial aims to evaluate the effect of the cold needle technique on pain and patient satisfaction during intramuscular injections administered to the ventrogluteal site.
The study was conducted in the internal medicine clinics of Prof. Dr. Cemil Taşçıoğlu City Hospital in Istanbul, Türkiye. A total of 78 adult patients receiving intramuscular vitamin B12 injections as part of their prescribed treatment participated in the study.
Read more
Participants were randomly assigned to an intervention group (n=40) or a control group (n=38). The intervention group received intramuscular injections using a cooled needle, while the control group received injections using the standard technique. Only the injection needle was cooled; the medication was not cooled.
Pain intensity and patient satisfaction were assessed after the injection using Visual Analog Scales (VAS).
The study aims to determine whether the cold needle technique reduces injection-related pain and improves patient satisfaction compared with the standard intramuscular injection technique.
Read the detailed description
This study was designed as a randomized controlled trial to investigate the effects of the cold needle technique on pain intensity and patient satisfaction during intramuscular injections administered to the ventrogluteal site.
The study included 78 adult patients who were receiving intramuscular vitamin B12 (cyanocobalamin) injections as part of their prescribed treatment in the internal medicine clinics of Prof. Dr. Cemil Taşçıoğlu City Hospital in Istanbul, Türkiye.
Participants were randomly allocated to two groups: an intervention group consisting of 40 patients and a control group consisting of 38 patients.
In the intervention group, sterile injection needles were cooled in an insulated container containing ice packs. The temperature was monitored using a thermometer. Immediately before the injection, the cooled needle was removed from its sterile packaging and attached to the syringe under aseptic conditions. Only the needle was cooled; the medication and syringe were not refrigerated.
In the control group, intramuscular injections were administered using the standard technique without cooling the needle.
All injections were administered to the ventrogluteal site by the same researcher. The injection procedure was otherwise identical in both groups.
Following the injection, participants assessed their pain intensity and satisfaction using Visual Analog Scales (VAS), with scores ranging from 0 to 10.
The primary outcome was injection-related pain intensity, and the secondary outcome was patient satisfaction.
- Conditions
- Injection Site Pain
- Being tested
- Cold Needle Technique, Standard Intramuscular Injection
- Keywords
- Cold needle technique, Intramuscular injection, Ventrogluteal site, Pain intensity, Patient satisfaction, Randomized controlled trial
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Needle TechniqueProcedure or surgery
Sterile injection needles were cooled in an insulated container containing ice packs. Needle temperature was monitored using a thermometer. Immediately before administration, the cooled needle was attached to the syringe under aseptic conditions. Only the needle was cooled; the vitamin B12 medication and syringe were not cooled. The injection was administered into the ventrogluteal site.
Standard Intramuscular InjectionProcedure or surgery
Participants received intramuscular vitamin B12 injections into the ventrogluteal site using a standard, non-cooled sterile injection needle. The injection procedure was otherwise identical to that used in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Cold Needle Technique | Experimental | Participants in this group (n=40) received intramuscular vitamin B12 injections into the ventrogluteal site using a cooled injection needle. Only the needle was cooled; the medication and syringe were not cooled. Receives: Procedure: Cold Needle Technique |
| Standard Injection Technique | Active comparator | Participants in this group (n=38) received intramuscular vitamin B12 injections into the ventrogluteal site using the standard injection technique without cooling the needle. Receives: Procedure: Standard Intramuscular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Following Intramuscular Injection
Pain intensity was assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Immediately after the intramuscular injection
Secondary outcomes (1)
Patient Satisfaction Following Intramuscular Injection
Patient satisfaction was assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates complete satisfaction. Higher scores indicate greater patient satisfaction.
Measured: Immediately after the intramuscular injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start16 Jul 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site 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
- Model description
- This study used a parallel-group randomized controlled design. A total of 78 patients were allocated to two groups: an intervention group receiving intramuscular injections with a cooled needle (n=40) and a control group receiving standard intramuscular injections (n=38). All injections were administered to the ventrogluteal site by the same researcher.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Ozcan, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860099
- Sponsor's protocol ID
- E-54022451-050.04-224357
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the sharing of de-identified individual participant data has not yet been made. Any future data sharing will be considered in accordance with institutional policies, ethical approval, and participant confidentiality requirements.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Cold Needle Technique on Pain and Patient Satisfaction Levels During Intramuscular Injection Administered to the Ventrogluteal Site
- ClinicalTrials.gov ID
- NCT07860099
- Acronym / sponsor ID
- E-54022451-050.04-224357
- Conditions
- Injection Site Pain
- Keywords
- Cold needle technique, Intramuscular injection, Ventrogluteal site, Pain intensity, Patient satisfaction, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 6 Oct 2026 (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 randomized controlled trial aims to evaluate the effect of the cold needle technique on pain and patient satisfaction during intramuscular injections administered to the ventrogluteal site.
The study was conducted in the internal medicine clinics of Prof. Dr. Cemil Taşçıoğlu City Hospital in Istanbul, Türkiye. A total of 78 adult patients receiving intramuscular vitamin B12 injections as part of their prescribed treatment participated in the study.
Participants were randomly assigned to an intervention group (n=40) or a control group (n=38). The intervention group received intramuscular injections using a cooled needle, while the control group received injections using the standard technique. Only the injection needle was cooled; the medication was not cooled.
Pain intensity and patient satisfaction were assessed after the injection using Visual Analog Scales (VAS).
The study aims to determine whether the cold needle technique reduces injection-related pain and improves patient satisfaction compared with the standard intramuscular injection technique.
Detailed description
This study was designed as a randomized controlled trial to investigate the effects of the cold needle technique on pain intensity and patient satisfaction during intramuscular injections administered to the ventrogluteal site.
The study included 78 adult patients who were receiving intramuscular vitamin B12 (cyanocobalamin) injections as part of their prescribed treatment in the internal medicine clinics of Prof. Dr. Cemil Taşçıoğlu City Hospital in Istanbul, Türkiye.
Participants were randomly allocated to two groups: an intervention group consisting of 40 patients and a control group consisting of 38 patients.
In the intervention group, sterile injection needles were cooled in an insulated container containing ice packs. The temperature was monitored using a thermometer. Immediately before the injection, the cooled needle was removed from its sterile packaging and attached to the syringe under aseptic conditions. Only the needle was cooled; the medication and syringe were not refrigerated.
In the control group, intramuscular injections were administered using the standard technique without cooling the needle.
All injections were administered to the ventrogluteal site by the same researcher. The injection procedure was otherwise identical in both groups.
Following the injection, participants assessed their pain intensity and satisfaction using Visual Analog Scales (VAS), with scores ranging from 0 to 10.
The primary outcome was injection-related pain intensity, and the secondary outcome was patient satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study used a parallel-group randomized controlled design. A total of 78 patients were allocated to two groups: an intervention group receiving intramuscular injections with a cooled needle (n=40) and a control group receiving standard intramuscular injections (n=38). All injections were administered to the ventrogluteal site by the same researcher.
| Arm | Type | Receives |
|---|---|---|
| Cold Needle Technique | Experimental | Procedure: Cold Needle TechniqueParticipants in this group (n=40) received intramuscular vitamin B12 injections into the ventrogluteal site using a cooled injection needle. Only the needle was cooled; the medication and syringe were not cooled. |
| Standard Injection Technique | Active comparator | Procedure: Standard Intramuscular InjectionParticipants in this group (n=38) received intramuscular vitamin B12 injections into the ventrogluteal site using the standard injection technique without cooling the needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older.
- Receiving a prescribed intramuscular vitamin B12 injection.
- No cognitive impairment.
- Able to communicate effectively.
- Willing to participate in the study and provide informed consent.
Key exclusion criteria (4 listed)
- Presence of a skin disease or infection at the injection site.
- Diagnosis of a neurological or psychiatric disorder.
- History of opioid use that may affect pain perception.
- Diagnosis of diabetes mellitus.
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 |
|---|---|---|
| Cold Needle TechniqueSterile injection needles were cooled in an insulated container containing ice packs. Needle temperature was monitored using a thermometer. Immediately before administration, the cooled needle was attached to the syringe under aseptic conditions. Only the needle was cooled; the vitamin B12 medication and syringe were not cooled. The injection was administered into the ventrogluteal site. | Procedure or surgery | Cold Needle Technique |
| Standard Intramuscular InjectionParticipants received intramuscular vitamin B12 injections into the ventrogluteal site using a standard, non-cooled sterile injection needle. The injection procedure was otherwise identical to that used in the intervention group. | Procedure or surgery | Standard Injection Technique |
Primary outcome
Pain Intensity Following Intramuscular Injection
Time frame: Immediately after the intramuscular injection
Pain intensity was assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
1 secondary outcome
Patient Satisfaction Following Intramuscular Injection
Time frame: Immediately after the intramuscular injection
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 Oct 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding the sharing of de-identified individual participant data has not yet been made. Any future data sharing will be considered in accordance with institutional policies, ethical approval, and participant confidentiality requirements.
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Recruiting
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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 Cold Needle Technique and Standard Intramuscular Injection in people with Injection Site Pain, run by Bezmialem Vakif 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 5 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 Oct 2026. 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 Intensity Following Intramuscular Injection (time frame: Immediately after the intramuscular injection). 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 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.