Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-01-05 @ 5:11 PM
Study NCT ID:
NCT07004166
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of TPR and Z Techniques on Pain and Drug Leakage in Intramuscular Injections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Procedure:\n\nEach participant will receive two injections, one into each ventrogluteal muscle. One side will be randomly assigned to the Z-track method, the other to the TPR method, using coin toss randomization. All injections will be administered by the same researcher using 3 mL of diclofenac sodium with a 21G (0.80x38 mm) needle. Injection speed will be 1 mL per 10 seconds.\n\nFor the Z-track method, the skin will be pulled laterally by 2.5-3.5 cm before needle insertion at a 90-degree angle. After aspiration and injection, the needle will be withdrawn and the skin released immediately.\n\nFor the TPR method, while the needle is inserted at a 90-degree angle, deep pressure will be applied to the muscle, then rapidly released to create a snapping motion that facilitates the injection. This technique relies on rapid muscle relaxation rather than needle movement by the dominant hand.\n\nA second blinded researcher will immediately measure leakage diameter with a millimeter ruler and evaluate'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain with visual analog scale', 'timeFrame': 'Within 5 minutes after intramuscular injection', 'description': 'Pain intensity measured with the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.'}], 'secondaryOutcomes': [{'measure': 'Drug leakage', 'timeFrame': 'Time Frame: Immediately after injection (within 1 minute)Description: Drug leakage will be observed immediately after intramuscular injection by checking the injection site for any visible medication leakage.', 'description': 'millimeter ruler to assess medication leakage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intramuscular Injection', 'Drug Leakage l', 'Pain', 'Z-Track', 'TPR Techniques'], 'conditions': ['Muscle Pain', 'Injection Site Pain']}, 'descriptionModule': {'briefSummary': 'This randomized, triple-blind clinical trial compares the effectiveness of Z-track and TPR (traction-pressure-release) techniques in reducing pain and medication leakage during ventrogluteal intramuscular injections. Pain is measured using VAS, and leakage is assessed with a millimeter scale. The study aims to identify a more efficient, less painful injection method.', 'detailedDescription': 'Introduction: Intramuscular (IM) injections are widely used for delivering medications due to their high bioavailability and quick absorption. However, they can cause significant local complications, especially pain, which may affect patient compliance. Various non-pharmacological techniques have been developed to reduce injection pain, including the Z-track method and the more recent TPR (traction-pressure-release) technique, based on the gate control theory of pain. While both aim to minimize pain, TPR has shown promise but lacks research regarding its effect on drug leakage.\n\nObjective: The study aims to compare the effectiveness of TPR and Z-track techniques in reducing pain and drug leakage during IM injections in the ventrogluteal site.\n\nMethod: This study is a triple-blind, randomized, two-group clinical trial with a parallel design. A total of 76 patients aged 16-40, prescribed with intramuscular diclofenac sodium, will be recruited. Each participant will receive both techniques-TPR and Z-track-in randomly assigned ventrogluteal muscles. Pain intensity will be measured using a Visual Analog Scale (VAS), and drug leakage will be assessed using millimetric paper and a ruler. All injections will be administered by the same nurse, and evaluation will be performed by blinded assessors.\n\nConclusion: This research seeks to provide evidence on the efficacy of the TPR technique as a potentially time- and cost-effective alternative to Z-track, particularly in minimizing injection-related pain and leakage, thereby improving patient comfort and treatment adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 16-40\n* Prescribed diclofenac sodium\n* No communication impairments\n* Healthy ventrogluteal muscles without sensory issues\n\nExclusion Criteria:\n\n* Wounds, redness, bruising, tenderness, or stiffness at the injection site\n* Injection in the past 2 weeks\n* Neuropathy or other medical conditions\n* BMI below 15 or above 35'}, 'identificationModule': {'nctId': 'NCT07004166', 'acronym': 'TPR_Z_PainLeak', 'briefTitle': 'Effects of TPR and Z Techniques on Pain and Drug Leakage in Intramuscular Injections', 'organization': {'class': 'OTHER', 'fullName': 'Cumhuriyet University'}, 'officialTitle': 'Effects of TPR Technique and Z Technique on Pain and Drug Leakage in Intramuscular Injections', 'orgStudyIdInfo': {'id': '15.05/2025 C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TPR (traction-pressure-release) technique', 'description': 'Intervention Type: Intramuscular drug administration with TPR technique Intervention Name: Diclofenac Sodium\n\nTPR method, while the needle is inserted at a 90-degree angle, deep pressure will be applied to the muscle, then rapidly released to create a snapping motion that facilitates the injection. This technique relies on rapid muscle relaxation rather than needle movement by the dominant hand.', 'interventionNames': ['Other: TPR method']}, {'type': 'EXPERIMENTAL', 'label': 'Z-track method', 'description': 'Intervention Type: Intramuscular drug administration with Z-track method Intervention Name: Diclofenac Sodium Z-track method, the skin will be pulled laterally by 2.5-3.5 cm before needle insertion at a 90-degree angle. After aspiration and injection, the needle will be withdrawn and the skin released immediately.', 'interventionNames': ['Other: Z-track method']}], 'interventions': [{'name': 'Z-track method', 'type': 'OTHER', 'description': 'Z-track method, the skin will be pulled laterally by 2.5-3.5 cm before needle insertion at a 90-degree angle. After aspiration and injection, the needle will be withdrawn and the skin released immediately.', 'armGroupLabels': ['Z-track method']}, {'name': 'TPR method', 'type': 'OTHER', 'description': 'TPR method, while the needle is inserted at a 90-degree angle, deep pressure will be applied to the muscle, then rapidly released to create a snapping motion that facilitates the injection. This technique relies on rapid muscle relaxation rather than needle movement by the dominant hand.', 'armGroupLabels': ['TPR (traction-pressure-release) technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58000', 'city': 'Sivas', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Murat Yıldırım, phd', 'role': 'CONTACT', 'email': 'mrtylldrm@gmail.com', 'phone': '903462795075', 'phoneExt': '05444500198'}], 'facility': 'Sivas Numune Hospital', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}, {'zip': '58000', 'city': 'Sivas', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'murat yıldırım, phd', 'role': 'CONTACT', 'email': 'mrtylldrm@gmail.com', 'phone': '903462795075'}, {'name': 'Hülya KOÇYİĞİT KAVAK, Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Şeyda Kazanç, Phd', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sivas State Hospital', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}], 'centralContacts': [{'name': 'Hülya KOÇYİĞİT KAVAK, Phd', 'role': 'CONTACT', 'email': 'hkocyigit@cumhuriyet.edu.tr', 'phone': '90555408876'}], 'overallOfficials': [{'name': 'Şeyda Kazanç, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'but no location'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I would like to share the research after it is completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumhuriyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd, Research Assitant', 'investigatorFullName': 'Hulya Kocyigit', 'investigatorAffiliation': 'Cumhuriyet University'}}}}