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

NCT07499687 | Not Yet Recruiting DMC

• 1 other identifier: BDEMİRCAN2
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Injection Techniques; Nursing Interventions; Injection Pain Prevention; Patient Satisfaction; Intramuscular Injection

Keywords

intramuscular injection; tpr technique; pain; satisfaction

Outcome Measures

Primary Outcomes (3)

• 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).

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

• 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.

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

• 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.

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients 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.

Other: TPR Injection Technique

Control group

NO INTERVENTION

Patients 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.

Interventions

TPR Injection Technique OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Ministry of Health of the Republic of Türkiye Başakşehir Çam And Sakura City Hospital Emergency Department

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 31891437 BACKGROUND

• 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.

  PMID: 27753676 BACKGROUND

• 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.

  PMID: 31588477 BACKGROUND

• 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.

  PMID: 27535654 BACKGROUND

• 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.

  PMID: 35385141 BACKGROUND

• 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.

  PMID: 36758552 BACKGROUND

• 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.

  PMID: 30693308 BACKGROUND

• 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.

  PMID: 33714700 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Burcu Demircan, Dr

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burcu Demircan, Dr

CONTACT

+90 212 401 26 00; bdemircan@bezmialem.edu.tr

Yasemin Kıyak Yorulmaz, MsC

CONTACT

+90 212 453 17 00; ykiyak@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants: Patients included in the study will be blinded to the injection technique used. Outcomes Assessor: All injections administered to patients in the experimental and control groups will be performed by a nurse who is a member of the research team. However, an independent nurse who is not involved in the research will be responsible for assessing the outcome measures obtained from the patients immediately after the procedure. This nurse will also be blinded to the study groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)