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Injection TechniquesTPRTDIMINCT07499687

Traction, Pressure, and Rapid Muscle Release (TPR) Technique During Intramuscular Injection: Effects on Pain and Patient Satisfaction

A study testing TPR Injection Technique in people with Injection Techniques and Nursing Interventions, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will be conducted to evaluate the effect of the Traction, Pressure, and Rapid Muscle Release (TPR) technique, an innovative method used during intramuscular vitamin B12 (cyanocobalamin) injections, on patients' pain and satisfaction levels compared with the conventional injection method. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
TPR Injection Technique
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Apr 2026to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in the study
  • Ability to speak and understand Turkish
  • Being between 18 and 65 years of age
  • Having a body mass index (BMI) between 18.5 and 30
  • No sensory impairment in the ventrogluteal muscles

Who cannot join

  • Presence of a scar, burn, redness, hematoma, bruising, tenderness, or induration at the injection site
  • History of intramuscular injection in the ventrogluteal region within the last 15 days
  • Presence of injection-related fear
  • Diagnosis of Diabetes Mellitus
  • History of neuropathy
  • Presence of any hearing, visual, or speech impairment
  • Presence of a mental disability
  • Use of oral or parenteral analgesic medication before the procedure.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Ministry of Health of the Republic of Türkiye Başakşehir Çam And Sakura City Hospital Emergency Department

    Istanbul, 34000

    Nalan NUHOĞLU, MsC, +90 533 048 64 06, nlnzdm@hotmail.com

    Demet DUMAN, Dr, +90 530 784 64 26, iklima-85@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of the Traction, Pressure, and Rapid Muscle Release (TPR) Technique on Pain and PatientSatisfaction During Intramuscular Injection: A Randomized Controlled Experimental Study

This study will be conducted to evaluate the effect of the Traction, Pressure, and Rapid Muscle Release (TPR) technique, an innovative method used during intramuscular vitamin B12 (cyanocobalamin) injections, on patients' pain and satisfaction levels compared with the conventional injection method.

Read the detailed description

Intramuscular (IM) drug injection is one of the most commonly used invasive medication administration methods performed under the responsibility of a licensed nurse in all healthcare settings where patients receive care. Medications administered via the IM route are often preferred because they allow faster drug absorption compared with oral or subcutaneous administration and enable the safe administration of irritating medications. The most frequently administered drug groups via the IM route include vaccines, hormones, vitamins, and antibiotics. Since IM injections are routinely performed by nurses as part of daily treatment practices, the procedure is often considered a simple technique. However, if IM injections are not performed correctly and carefully, serious complications may occur. Potential complications associated with IM injections include abscess, pain, cellulitis, tissue damage, hematoma, nerve injury, muscle fibrosis, and necrosis. Among these complications, pain is the most commonly reported. Studies have indicated that patients often perceive pain associated with intramuscular injections as one of the most severe types of pain, which may lead to the development of significant fear in patients. Inadequate management of pain during injection procedures may lead to the development of injection-related fear and non-adherence to treatment and care, which may eventually result in delayed care and treatment, needle phobia, and avoidance of healthcare services. Pain management is a fundamental component of nursing care and is considered both a legal and ethical responsibility of nurses. Moreover, reducing pain associated with IM injections can strengthen the patient-nurse relationship, increase patient satisfaction, and improve cooperation during care. For painless and comfortable IM injections, it is important to follow safe injection practices such as selecting the appropriate injection site, patient position, and needle length; using the double-needle technique; applying sterile technique; injecting the medication slowly; and distracting the patient. However, despite these precautions, some patients may still experience pain during IM injection procedures. Therefore, pharmacological and non-pharmacological methods may be used to reduce pain. Among the pharmacological methods commonly used to reduce pain are topical anesthetic agents and cold spray applications. However, the use of topical anesthetics is limited due to the risk of systemic toxicity, local complications, and their relatively slow and weak analgesic effects. Currently, in addition to pharmacological treatments, various non-pharmacological methods such as massage, pressure, local cold-heat application, acupressure, Buzzy, and ShotBlocker devices are also used in the management of pain associated with IM injections. Nevertheless, not all of these interventions are practical, quick to apply, or cost-effective. Therefore, there is a need for easy-to-use, rapid, and cost-effective methods to reduce pain associated with IM injections. One of the recently introduced techniques is the Traction, Pressure, and Rapid Muscle Release (TPR) technique. In the TPR technique, after identifying the injection site within the muscle tissue, the skin layers are pulled using the thumb and index finger while the needle is held at a 90° angle. Then, deep pressure is applied to the muscle with the same two fingers simultaneously, after which the pressure is rapidly released, and the medication is injected quickly. The mechanism of the TPR technique is based on the gate control theory of pain. In this method, skin traction and deep pressure applied to the muscle simultaneously with the injection activate large-diameter, low-threshold mechanoreceptive nerve fibers (thick A-beta fibers). This activation facilitates the closure of the pain gate at the spinal cord level, thereby reducing the perception of pain. Studies conducted using the TPR method have reported reduced pain levels among patients. A review of the literature shows that only two studies have investigated this innovative, simple, and cost-effective technique, and it has been recommended that the method be tested in different sample groups and cultural contexts. In this context, the present study was planned as a randomized controlled experimental study to determine the effect of the TPR technique applied during intramuscular injections on patients' pain and satisfaction levels among patients presenting to the emergency department of a public hospital in Türkiye.

This study will be conducted using a post-test control group randomized controlled experimental design. The sample of the study will consist of patients who present to the emergency department of a hospital to receive intramuscular (IM) cyanocobalamin (vitamin B12) injection, who voluntarily agree to participate in the study, and who meet the inclusion and exclusion criteria. Patients to be included in the study sample will be randomly assigned to the experimental and control groups according to the last digit of the protocol number given to them at the time of hospital admission. The sample size of the study was calculated by power analysis. The sample size was determined using the G*Power 3.1.9.7 program with the t-test for the difference between two independent means. In the analysis, 80% statistical power, a 95% confidence level (1-α), an effect size of f = 0.50, and a one-tailed hypothesis assumption were considered. As a result of the calculation, the minimum sample size was determined as 102 participants (experimental: 51; control: 51). Accordingly, in the study, 51 patients in the experimental group will receive cyanocobalamin injection using the TPR injection technique, while 51 patients in the control group will receive cyanocobalamin injection using the conventional injection technique. The data obtained from the study will be analyzed using the SPSS (Statistical Package for the Social Sciences) 29.0 software package. Data will be collected using the "Patient Information Form," "Visual Analog Scale (VAS) - Pain," and "Visual Analog Scale (VAS) - Satisfaction."

Being tested
TPR Injection Technique
Keywords
intramuscular injection, tpr technique, pain, satisfaction
Medical subject headings
Patient Satisfaction, Pain, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPR Injection TechniqueOther

    To examine the effect of the Traction, Pressure, and Rapid Muscle Release (TPR) injection technique, a non-pharmacological method, on patients' pain and satisfaction levels during cyanocobalamin (vitamin B12) intramuscular injection.

Study groups in NCT07499687
Study groupRoleWhat they receive
TPR Technique GroupExperimentalPatients who present to the hospital and are prescribed cyanocobalamin (vitamin B12) injections by a physician will be included in the study. In this group, injections will be administered using the Traction, Pressure, and Rapid Muscle Release (TPR) technique as part of routine clinical care and not for research purposes.
Receives: Other: TPR Injection Technique
Standard Injection Technique GroupNo interventionPatients who present to the hospital and are prescribed cyanocobalamin (vitamin B12) injections by a physician will be included in the study. In this group, injections will be administered using the standard injection technique as part of routine clinical care and not for research purposes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Information Form

    The data collection form, developed by the researchers in line with the current literature, consists of questions regarding the patients' sociodemographic characteristics and anthropometric measurements. The form includes questions about patients' age, gender, marital status, educational level, employment status, history of chronic disease, regular medication use, and previous intramuscular (IM) injection experience, as well as three questions related to anthropometric measurements including height, weight, and body mass index (BMI).

    Measured: Immediately before the administration of the cyanocobalamin (vitamin B12) injection.

  2. Visual Analogue Scale (VAS)-Pain

    First defined in 1921 and used to assess patients' subjective pain levels, the VAS is a form consisting of a horizontal line 10 cm long.

    The leftmost part of this measurement tool indicates "no pain," while the rightmost part indicates "unbearable pain." A high score on the scale indicates severe pain, while a low score indicates mild pain. The scale is scored as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.

    Measured: Immediately after the administration of the cyanocobalamin (vitamin B12) injection.

  3. Visual Comparison Scale for Satisfaction

    In this scale, satisfaction levels are determined by scoring between 0 and 10. A score of "0" represents the lowest level of satisfaction, while a score of "10" represents the highest level of satisfaction.

    Patients are asked to indicate the level of their pain on a scale from 0 to 10, with the numerical value representing the patient's satisfaction level.

    Measured: Immediately after the administration of the cyanocobalamin (vitamin B12) injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start6 Apr 2026
  3. Primary completion10 Jul 2026
  4. Study completionNov 2026 (estimated)

Resources

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
Randomized Controlled Trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07499687
Sponsor's protocol ID
BDEMİRCAN2
Acronym
TPRTDIMI
Status last verified
Mar 2026
First submitted
24 Mar 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data of the patients included in this study are not publicly available due to confidentiality considerations but are available from the corresponding author upon reasonable request.

Publications

  • Inangil D, Inangil G. The effect of acupressure (GB30) on intramuscular injection pain and satisfaction: Single-blind, randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1094-1101. doi: 10.1111/jocn.15172. Epub 2020 Jan 20.

    PubMed 31891437
  • Yilmaz D, Khorshid L, Dedeoglu Y. The Effect of the Z-Track Technique on Pain and Drug Leakage in Intramuscular Injections. Clin Nurse Spec. 2016 Nov/Dec;30(6):E7-E12. doi: 10.1097/NUR.0000000000000245.

    PubMed 27753676
  • Bilge S, Aydin A, Gun C, Aldinc H, Acar YA, Yaylaci S, Cinar O, Balci V. Comparison of the efficacy of ShotBlocker and cold spray in reducing intramuscular injection-related pain in adults. A prospective, randomized, controlled trial. Saudi Med J. 2019 Oct;40(10):996-1002. doi: 10.15537/smj.2019.10.24322.

    PubMed 31588477
  • Ozturk D, Baykara ZG, Karadag A, Eyikara E. The effect of the application of manual pressure before the administration of intramuscular injections on students' perceptions of postinjection pain: a semi-experimental study. J Clin Nurs. 2017 Jun;26(11-12):1632-1638. doi: 10.1111/jocn.13530. Epub 2016 Nov 24.

    PubMed 27535654
  • Gurdap Z, Cengiz Z. Comparison of cold spray and shotblocker to reduce intramuscular injection pain: A randomized controlled trial. J Clin Pharm Ther. 2022 Aug;47(8):1249-1256. doi: 10.1111/jcpt.13663. Epub 2022 Apr 6.

    PubMed 35385141
  • Cmc S, Lord H, Vargese SS, Kurian N, Cherian SA, Mathew E, Fernandez R. Effectiveness of physical stimulation for reducing injection pain in adults receiving intramuscular injections: a systematic review and meta-analysis. JBI Evid Synth. 2023 Feb 1;21(2):373-400. doi: 10.11124/JBIES-20-00590.

    PubMed 36758552
  • Salari M, Estaji Z, Akrami R, Rad M. Comparison of skin traction, pressure, and rapid muscle release with conventional method on intramuscular injection pain: A randomized clinical trial. J Educ Health Promot. 2018 Dec 28;7:172. doi: 10.4103/jehp.jehp_216_18. eCollection 2018.

    PubMed 30693308
  • Heshmatifar N, Salari M, Rad M, Afshari Saleh T, Borzoee F, Rastaghi S. A New Approach on the pain management of intramuscular injection: A Triple-Blind Randomized Clinical Trial. Pain Manag Nurs. 2022 Jun;23(3):353-358. doi: 10.1016/j.pmn.2021.01.010. Epub 2021 Mar 11.

    PubMed 33714700

Questions about this trial

What is this clinical trial studying?

A study testing TPR Injection Technique in people with Injection Techniques and Nursing Interventions, 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 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: looking for participants now, as of the sponsor's last update on 8 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Burcu Demircan, Dr (+90 212 401 26 00 ext. 4613, bdemircan@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Information Form (time frame: Immediately before the administration of the cyanocobalamin (vitamin B12) injection.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07499687, which also lists 8 linked publications.

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 8 Oct 2026.

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