Intramuscular Injection PainNCT07623421
Comparison of Internal Rotation, Local Cold and ShotBlocker on Intramuscular Injection Pain and Comfort
A study testing Standard intramuscular injection, Internal rotation of the extremity and Local cold application in people with Intramuscular Injection Pain and Patient Comfort, run by MEDICANA at 1 site in Turkey (Türkiye).
Trial summary
This single-centre, randomized, counterbalanced, within-subjects clinical trial compared four techniques for reducing pain and improving comfort during ventrogluteal intramuscular cyanocobalamin injection in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intramuscular Injection Pain, Patient Comfort
- What is being tested?
- Standard intramuscular injection, Internal rotation of the extremity and Local cold application
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jul 2019to 31 Dec 2019
- 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
- Adults aged 18 years or older.
- Presented to the family health centre for a prescribed course of cyanocobalamin intramuscular injection.
- Able to read, understand, and respond to study instruments in Turkish.
- Provided written informed consent.
Who cannot join
- Contraindication to ventrogluteal intramuscular injection.
- Local skin lesion, inflammation, edema, scarring, or sensory disturbance over either ventrogluteal site.
- Body mass index less than 18.5 or greater than 35 kg/m2.
- Concurrent regular analgesic or anti-inflammatory use.
- Chronic pain condition.
- Clinically diagnosed psychiatric disorder under active treatment.
- Pregnancy or lactation.
- Known cold intolerance, cold urticaria, or Raynaud phenomenon.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Internal Rotation of the Extremity, Local Cold Application and ShotBlocker on Pain and Comfort During Ventrogluteal Intramuscular Cyanocobalamin Injection: A Randomized Counterbalanced Within-Subjects Clinical Trial
This single-centre, randomized, counterbalanced, within-subjects clinical trial compared four techniques for reducing pain and improving comfort during ventrogluteal intramuscular cyanocobalamin injection in adults. Participants presenting to a family health centre for prescribed vitamin B12 injection each received four injections, one with each technique: standard injection, internal rotation of the extremity, local cold application, and ShotBlocker. Technique order was assigned using a 4 x 4 Latin-square randomization. Pain and comfort were measured immediately after each injection using 0-10 participant-reported scales.
Read the detailed description
Adults aged 18 years or older who presented to TOKI Family Health Centre in Sivas, Turkey for prescribed cyanocobalamin intramuscular injection were enrolled between July and December 2019. Each participant received all four ventrogluteal injection techniques across four visits scheduled 24-48 hours apart. The order of techniques was randomized and counterbalanced using a 4 x 4 Latin-square sequence, with allocation concealed in sealed, opaque, sequentially numbered envelopes. Blinding of participants and the administering nurse was not feasible because the procedural techniques were visibly distinct, but the outcome assessor who entered and analyzed pain and comfort scores was blinded to sequence assignment until database lock. All injections were administered by the same experienced registered nurse using cyanocobalamin 1 mg in 1 mL and a 22-gauge, 38-mm needle. Pain was assessed using a 0-10 Visual Analogue Scale and comfort using a 0-10 numerical comfort scale immediately after each injection.
- Conditions
- Intramuscular Injection Pain, Patient Comfort
- Being tested
- Standard intramuscular injection, Internal rotation of the extremity, Local cold application, ShotBlocker
- Keywords
- Intramuscular injection, Injection pain, Patient comfort, Ventrogluteal site, Local cold application, ShotBlocker, Internal rotation, Non-pharmacological pain management, Nursing intervention, Randomized controlled trial, Cyanocobalamin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard intramuscular injectionProcedure or surgery
Standard ventrogluteal intramuscular cyanocobalamin injection.
Internal rotation of the extremityProcedure or surgery
Participant internally rotated the foot of the injection-side leg before and during ventrogluteal injection.
Local cold applicationProcedure or surgery
Cold gel pack application to the injection site for 3 minutes before ventrogluteal injection.
ShotBlockerDevice
Also called Bionix ShotBlocker
ShotBlocker device applied with firm contact around the injection site during needle insertion, medication delivery, and needle withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| Standard Intramuscular Injection | Active comparator | Ventrogluteal intramuscular injection using standard positioning, skin antisepsis, 90-degree needle insertion, cyanocobalamin 1 mg/1 mL delivered over 5 seconds, and gauze after withdrawal without massage. Receives: Procedure: Standard intramuscular injection |
| Internal Rotation of the Extremity | Experimental | Standard ventrogluteal injection with the participant internally rotating the foot of the injection-side leg so the great toe points medially from immediately before needle insertion until needle withdrawal. Receives: Procedure: Internal rotation of the extremity |
| Local Cold Application | Experimental | A 10 x 10 cm cold gel pack stored at -18 degrees C, wrapped in clean cotton gauze, was applied to the injection site for 3 minutes before skin antisepsis and otherwise standard injection. Receives: Procedure: Local cold application |
| ShotBlocker | Experimental | A U-shaped ShotBlocker device was placed over the injection site with firm contact between the blunt projections and the skin during needle insertion, medication delivery, and withdrawal; the injection was otherwise standard. Receives: Device: ShotBlocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during intramuscular injection
Participant-reported pain measured immediately after each injection using a 0-10 Visual Analogue Scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: Immediately after each injection
Comfort during intramuscular injection
Participant-reported comfort measured immediately after each injection using a 0-10 numerical comfort scale, where 0 indicates extremely uncomfortable and 10 indicates extremely comfortable.
Measured: Immediately after each injection
Secondary outcomes (1)
Pain and comfort by participant characteristics
Pain and comfort scores were examined by sex, age group, body mass index category, educational background, and previous intramuscular injection experience.
Measured: Immediately after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start9 Jul 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intramuscular Injection 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
- Crossover
- Model description
- Each participant received all four injection techniques across four visits in a randomized, counterbalanced Latin-square order.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDICANA
- Collaborators
- Tokat Gaziosmanpasa University, TOKI Family Health Centre, Sivas Provincial Health Directorate
- Responsible party
- Principal investigator, Ahmet Altun, Sivas Medicana Hospital
- Investigators
- Tuba Karabey, Principal investigator, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623421
- Sponsor's protocol ID
- IMPAIN-2019-SIVAS
- Other IDs
- 2019-07/02
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analyzed during the study are not publicly available because the participant consent form did not include explicit permission for open data sharing. Data may be available from the corresponding author on reasonable request and subject to local ethics governance approval.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Internal Rotation of the Extremity, Local Cold Application and ShotBlocker on Pain and Comfort During Ventrogluteal Intramuscular Cyanocobalamin Injection: A Randomized Counterbalanced Within-Subjects Clinical Trial
- ClinicalTrials.gov ID
- NCT07623421
- Acronym / sponsor ID
- IMPAIN-2019-SIVAS
- Conditions
- Intramuscular Injection Pain, Patient Comfort
- Keywords
- Intramuscular injection, Injection pain, Patient comfort, Ventrogluteal site, Local cold application, ShotBlocker, Internal rotation, Non-pharmacological pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- MEDICANA
- Collaborators
- Tokat Gaziosmanpasa University, TOKI Family Health Centre, Sivas Provincial Health Directorate
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Jun 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 single-centre, randomized, counterbalanced, within-subjects clinical trial compared four techniques for reducing pain and improving comfort during ventrogluteal intramuscular cyanocobalamin injection in adults. Participants presenting to a family health centre for prescribed vitamin B12 injection each received four injections, one with each technique: standard injection, internal rotation of the extremity, local cold application, and ShotBlocker. Technique order was assigned using a 4 x 4 Latin-square randomization. Pain and comfort were measured immediately after each injection using 0-10 participant-reported scales.
Detailed description
Adults aged 18 years or older who presented to TOKI Family Health Centre in Sivas, Turkey for prescribed cyanocobalamin intramuscular injection were enrolled between July and December 2019. Each participant received all four ventrogluteal injection techniques across four visits scheduled 24-48 hours apart. The order of techniques was randomized and counterbalanced using a 4 x 4 Latin-square sequence, with allocation concealed in sealed, opaque, sequentially numbered envelopes. Blinding of participants and the administering nurse was not feasible because the procedural techniques were visibly distinct, but the outcome assessor who entered and analyzed pain and comfort scores was blinded to sequence assignment until database lock. All injections were administered by the same experienced registered nurse using cyanocobalamin 1 mg in 1 mL and a 22-gauge, 38-mm needle. Pain was assessed using a 0-10 Visual Analogue Scale and comfort using a 0-10 numerical comfort scale immediately after each injection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Each participant received all four injection techniques across four visits in a randomized, counterbalanced Latin-square order.
| Arm | Type | Receives |
|---|---|---|
| Standard Intramuscular Injection | Active comparator | Procedure: Standard intramuscular injectionVentrogluteal intramuscular injection using standard positioning, skin antisepsis, 90-degree needle insertion, cyanocobalamin 1 mg/1 mL delivered over 5 seconds, and gauze after withdrawal without massage. |
| Internal Rotation of the Extremity | Experimental | Procedure: Internal rotation of the extremityStandard ventrogluteal injection with the participant internally rotating the foot of the injection-side leg so the great toe points medially from immediately before needle insertion until needle withdrawal. |
| Local Cold Application | Experimental | Procedure: Local cold applicationA 10 x 10 cm cold gel pack stored at -18 degrees C, wrapped in clean cotton gauze, was applied to the injection site for 3 minutes before skin antisepsis and otherwise standard injection. |
| ShotBlocker | Experimental | Device: ShotBlockerA U-shaped ShotBlocker device was placed over the injection site with firm contact between the blunt projections and the skin during needle insertion, medication delivery, and withdrawal; the injection was otherwise standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Presented to the family health centre for a prescribed course of cyanocobalamin intramuscular injection.
- Able to read, understand, and respond to study instruments in Turkish.
- Provided written informed consent.
Key exclusion criteria (8 listed)
- Contraindication to ventrogluteal intramuscular injection.
- Local skin lesion, inflammation, edema, scarring, or sensory disturbance over either ventrogluteal site.
- Body mass index less than 18.5 or greater than 35 kg/m2.
- Concurrent regular analgesic or anti-inflammatory use.
- Chronic pain condition.
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 |
|---|---|---|
| Standard intramuscular injectionStandard ventrogluteal intramuscular cyanocobalamin injection. | Procedure or surgery | Standard Intramuscular Injection |
| Internal rotation of the extremityParticipant internally rotated the foot of the injection-side leg before and during ventrogluteal injection. | Procedure or surgery | Internal Rotation of the Extremity |
| Local cold applicationCold gel pack application to the injection site for 3 minutes before ventrogluteal injection. | Procedure or surgery | Local Cold Application |
| ShotBlockerAlso: Bionix ShotBlockerShotBlocker device applied with firm contact around the injection site during needle insertion, medication delivery, and needle withdrawal. | Device | ShotBlocker |
Primary outcome
Pain intensity during intramuscular injection
Time frame: Immediately after each injection
Participant-reported pain measured immediately after each injection using a 0-10 Visual Analogue Scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
Comfort during intramuscular injection
Time frame: Immediately after each injection
Participant-reported comfort measured immediately after each injection using a 0-10 numerical comfort scale, where 0 indicates extremely uncomfortable and 10 indicates extremely comfortable.
1 secondary outcome
Pain and comfort by participant characteristics
Time frame: Immediately after each 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 3 Jun 2026.
- Individual participant dataSharing planned: No. The datasets generated and analyzed during the study are not publicly available because the participant consent form did not include explicit permission for open data sharing. Data may be available from the corresponding author on reasonable request and subject to local ethics governance approval.
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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.
Tuba Karabey principal investigator
Tokat Gaziosmanpasa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard intramuscular injection, Internal rotation of the extremity and Local cold application in people with Intramuscular Injection Pain and Patient Comfort, run by MEDICANA 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 4 inclusion and 8 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 3 Jun 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 during intramuscular injection (time frame: Immediately after each injection). 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 3 Jun 2026.