Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06845605
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2024-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Behind the Needle: Healthcare Professionals' Perspectives on HD Needling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D005402', 'term': 'Fistula'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Healthcare professionals' (registered nurses and healthcare assistants) perspectives on the needling experience, with a focus on identifying areas for improvement and informing targeted training programs to enhance the overall patient experience.", 'timeFrame': 'March 2024'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Haemodialysis', 'Haemodialysis needling', 'End-Stage Renal Disease', 'Fistula', 'Cannulation'], 'conditions': ['Perspective of Healthcare Professionals Haemodialysis Needling', 'Dialysis']}, 'referencesModule': {'references': [{'pmid': '26157184', 'type': 'BACKGROUND', 'citation': 'Sutton J, Austin Z. Qualitative Research: Data Collection, Analysis, and Management. Can J Hosp Pharm. 2015 May-Jun;68(3):226-31. doi: 10.4212/cjhp.v68i3.1456. No abstract available.'}, {'pmid': '28316703', 'type': 'BACKGROUND', 'citation': 'Manoochehri H, Imani E, Atashzadeh-Shoorideh F, Alavi-Majd A. Competence of novice nurses: role of clinical work during studying. J Med Life. 2015;8(Spec Iss 4):32-38.'}, {'pmid': '28899257', 'type': 'BACKGROUND', 'citation': "Hagerty TA, Samuels W, Norcini-Pala A, Gigliotti E. Peplau's Theory of Interpersonal Relations: An Alternate Factor Structure for Patient Experience Data? Nurs Sci Q. 2017 Apr;30(2):160-167. doi: 10.1177/0894318417693286."}, {'pmid': '38106606', 'type': 'BACKGROUND', 'citation': 'Duncanson EL, Chur-Hansen A, Le Leu RK, Macauley L, Burke ALJ, Donnelly FF, Collins KL, McDonald SP, Jesudason S. Dialysis Needle-Related Distress: Patient Perspectives on Identification, Prevention, and Management. Kidney Int Rep. 2023 Sep 14;8(12):2625-2634. doi: 10.1016/j.ekir.2023.09.011. eCollection 2023 Dec.'}, {'pmid': '35244357', 'type': 'BACKGROUND', 'citation': "Rahmah NM, Hariyati TS, Sahar J. Nurses' efforts to maintain competence: a qualitative study. J Public Health Res. 2021 Dec 1;11(2):2736. doi: 10.4081/jphr.2021.2736."}, {'pmid': '24131509', 'type': 'BACKGROUND', 'citation': 'Napalkov P, Felici DM, Chu LK, Jacobs JR, Begelman SM. Incidence of catheter-related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis. BMC Cardiovasc Disord. 2013 Oct 16;13:86. doi: 10.1186/1471-2261-13-86.'}, {'pmid': '36409734', 'type': 'BACKGROUND', 'citation': 'Alsbrooks K, Hoerauf K. Prevalence, causes, impacts, and management of needle phobia: An international survey of a general adult population. PLoS One. 2022 Nov 21;17(11):e0276814. doi: 10.1371/journal.pone.0276814. eCollection 2022.'}, {'pmid': '31423945', 'type': 'BACKGROUND', 'citation': 'Hill K, Sharp R, Childs J, Esterman A, Le Leu R, Juneja R, Jesudason S. Cannulation practices at haemodialysis initiation via an arteriovenous fistula or arteriovenous graft. J Vasc Access. 2020 Sep;21(5):573-581. doi: 10.1177/1129729819869093. Epub 2019 Aug 18.'}, {'pmid': '29929090', 'type': 'BACKGROUND', 'citation': 'Lamb PC, Norton C. Nurses experiences of using clinical competencies a qualitative study. Nurse Educ Pract. 2018 Jul;31:177-181. doi: 10.1016/j.nepr.2018.06.006. Epub 2018 Jun 12.'}, {'pmid': '35034481', 'type': 'BACKGROUND', 'citation': "Fielding C, Bramley L, Stalker C, Brand S, Toft S, Buchanan H. Patients' experiences of cannulation of arteriovenous access for haemodialysis: A qualitative systematic review. J Vasc Access. 2023 Sep;24(5):1121-1133. doi: 10.1177/11297298211067630. Epub 2022 Jan 16."}, {'pmid': '35194215', 'type': 'BACKGROUND', 'citation': 'Bello AK, Okpechi IG, Osman MA, Cho Y, Htay H, Jha V, Wainstein M, Johnson DW. Epidemiology of haemodialysis outcomes. Nat Rev Nephrol. 2022 Jun;18(6):378-395. doi: 10.1038/s41581-022-00542-7. Epub 2022 Feb 22.'}], 'seeAlsoLinks': [{'url': 'https://salford.figshare.com/collections/_/7366282', 'label': "Moore, C., Ellis-Caird, H., Fielding, C., et al. (2024). Patients' perspectives on key aspects influencing needling for haemodialysis: A qualitative study. Manuscript in preparation"}, {'url': 'https://www.fons.org/wp-content/uploads/2024/02/IPDJ_10_01_08.pdf', 'label': 'Edgar, Denise \\& Wilson, Valerie \\& Moroney, Tracey. (2020). Which is it, person-centred culture, practice or care? It matters. International Practice Development Journal, 10, 1-17. 10.19043/ipdj.101.008.'}, {'url': 'https://www.researchgate.net/publication/235356393_Using_thematic_analysis_in_psychology', 'label': 'Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006;3(2):77-101'}]}, 'descriptionModule': {'briefSummary': "Haemodialysis is essential for patients with End-Stage Renal Disease (ESRD), requiring consistent vascular access through arteriovenous fistulas or grafts. This involves frequent needling, a procedure that is painful and distressing for many patients, causing significant emotional and physical demands on healthcare professionals working in the dialysis units. In the UK, about 30,000 patients receive haemodialysis, involving over 300 needling procedures annually.\n\nHealthcare professionals (Registered nurses and healthcare assistants) play a crucial role, with their expertise directly affecting patient outcomes. However, 60% of HCPs (healthcare professionals) report high job-related stress, particularly due to needling demands. Effective needling requires not only technical proficiency but also managing patient pain and anxiety. Strong staff-patient relationships, characterized by empathy and understanding, can enhance the needling experience. Challenges for dialysis unit staff includes the technical difficulty of needling and the emotional burden of patient care. Studies highlight the need for better training and support systems to help them cope with these demands.\n\nUnderstanding healthcare professionals' perspectives can identify areas for improvement, inform training programs, and improve experiences in dialysis units. Research by Rahmah et al. (2018) and Duncanson (2023) emphasizes the importance of HCPs skills and the psychological toll on them, suggesting further exploration of this area is needed. The primary aim of this research is to examine HCPs perspectives on the needling experience in haemodialysis, aiming to identify improvement areas and inform targeted training programs to enhance patient experiences. The study will utilize a qualitative exploratory design with semi-structured interviews to gather in-depth insights from HCPs. Data will be collected from renal dialysis units at East and North Hertfordshire NHS Trust, involving 12 to 16 registered nurses performing needling procedures. Thematic analysis will be used to analyse interview transcripts and identify key themes related to technical skills, communication barriers, and patient-related factors. The study will run for 10 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All data will be collected in the renal dialysis units of ENHT consisting of one main unit and four satellite units. The service provides in-centre haemodialysis to over 600 patients. Eligible nursing staff will be drawn from all service dialysis units.\n\nThe study aims to recruit between 12 to 16 HCPs (registered nurses and healthcare assistants) from dialysis units within East and North Hertfordshire NHS Trust (ENHT). The sample size will be determined based on the concept of information power, ensuring that the data collected is sufficient to address the research questions effectively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be registered nurses or Band 3 healthcare assistants who perform needling procedures in a haemodialysis unit.\n* Participants must be employed at the renal dialysis units of East and North Hertfordshire NHS Trust (ENHT), including both the main unit and its satellite units.\n* Participants must be willing to participate in the study and share their experiences.\n* Participants must be able to speak English fluently to ensure they can communicate effectively, providing rich and comprehensive information.\n\nExclusion Criteria:\n\n•Registered nurses or healthcare assistants who do not perform needling procedures in a haemodialysis unit will not be eligible to participate.'}, 'identificationModule': {'nctId': 'NCT06845605', 'briefTitle': "Behind the Needle: Healthcare Professionals' Perspectives on HD Needling", 'organization': {'class': 'OTHER_GOV', 'fullName': 'East and North Hertfordshire NHS Trust'}, 'officialTitle': "A Qualitative Exploration Study of Healthcare Professionals' Perspectives in Haemodialysis Needling to Enhance Patients' Overall Experience", 'orgStudyIdInfo': {'id': 'RD2024-55'}}, 'contactsLocationsModule': {'locations': [{'zip': 'SG1 4AB', 'city': 'Stevenage', 'state': 'Hertfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Eunice Doctolero', 'role': 'CONTACT'}], 'facility': 'East and North Hertfordshire NHS Trust', 'geoPoint': {'lat': 51.90224, 'lon': -0.20256}}], 'centralContacts': [{'name': 'Eunice Ann Doctolero, Bachelor of Science in Nursing', 'role': 'CONTACT', 'email': 'eunice.doctolero@nhs.net', 'phone': '+447737044516'}, {'name': 'Toral Odedra', 'role': 'CONTACT', 'email': 'toral.odedra@nhs.net', 'phone': '01438284379'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East and North Hertfordshire NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}