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Набор скоро начнётся NCT07499687

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

Без фазы С лечением Injection Techniques Nursing Interventions Injection Pain Prevention Patient Satisfaction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: TPR Injection Technique.
Кому может быть актуально
Состояния в реестре: Injection Techniques, Nursing Interventions, Injection Pain Prevention, Patient Satisfaction. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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."

Вмешательства

  • Другое TPR Injection Technique
    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.

Первичные конечные точки

  • Patient Information Form [Срок оценки: Immediately before the administration of the cyanocobalamin (vitamin B12) injection.]
  • Visual Analogue Scale (VAS)-Pain [Срок оценки: Immediately after the administration of the cyanocobalamin (vitamin B12) injection.]
  • Visual Comparison Scale for Satisfaction [Срок оценки: Immediately after the administration of the cyanocobalamin (vitamin B12) injection.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ministry of Health of the Republic of Türkiye Başakşehir Çam And Sakura City Hospital Emer — Istanbul

Публикации

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT07499687 · BDEMİRCAN2

Первоисточники (государственные реестры)

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