Intramuscular Injection Pain, Patient Comfort
Conditions
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
Brief 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. 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.
Interventions
PROCEDUREStandard intramuscular injection
Standard ventrogluteal intramuscular cyanocobalamin injection.
PROCEDUREInternal rotation of the extremity
Participant internally rotated the foot of the injection-side leg before and during ventrogluteal injection.
PROCEDURELocal cold application
Cold gel pack application to the injection site for 3 minutes before ventrogluteal injection.
DEVICEShotBlocker
ShotBlocker device applied with firm contact around the injection site during needle insertion, medication delivery, and needle withdrawal.
Sponsors
MEDICANA
Tokat Gaziosmanpasa University
TOKI Family Health Centre
Sivas Provincial Health Directorate
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and the administering nurse were not blinded because the procedures were visibly distinct. The outcome assessor who entered and analyzed pain and comfort scores was blinded to sequence assignment until the database was locked.
Intervention model description
Each participant received all four injection techniques across four visits in a randomized, counterbalanced Latin-square order.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during intramuscular injection | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain and comfort by participant characteristics | Immediately after each injection | Pain and comfort scores were examined by sex, age group, body mass index category, educational background, and previous intramuscular injection experience. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORTuba Karabey
Tokat Gaziosmanpasa University
Outcome results
None listed