NCT06845605

Brief Summary

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. Healthcare 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. Understanding 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 25, 2025

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 30, 2024

Last Update Submit

February 24, 2025

Conditions

Keywords

HaemodialysisHaemodialysis needlingEnd-Stage Renal DiseaseFistulaCannulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    March 2024

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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. The 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.

You may qualify if:

  • Participants must be registered nurses or Band 3 healthcare assistants who perform needling procedures in a haemodialysis unit.
  • 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.
  • Participants must be willing to participate in the study and share their experiences.
  • Participants must be able to speak English fluently to ensure they can communicate effectively, providing rich and comprehensive information.

You may not qualify if:

  • Registered nurses or healthcare assistants who do not perform needling procedures in a haemodialysis unit will not be eligible to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East and North Hertfordshire NHS Trust

Stevenage, Hertfordshire, SG1 4AB, United Kingdom

RECRUITING

Related Publications (11)

  • 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: 26157184BACKGROUND
  • 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: 28316703BACKGROUND
  • 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: 28899257BACKGROUND
  • 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: 38106606BACKGROUND
  • 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: 35244357BACKGROUND
  • 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: 24131509BACKGROUND
  • 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: 36409734BACKGROUND
  • 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: 31423945BACKGROUND
  • 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: 29929090BACKGROUND
  • 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: 35034481BACKGROUND
  • 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.

    PMID: 35194215BACKGROUND

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicFistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Central Study Contacts

Eunice Ann Doctolero, Bachelor of Science in Nursing

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2024

First Posted

February 25, 2025

Study Start

October 30, 2024

Primary Completion

January 31, 2025

Study Completion

May 1, 2025

Last Updated

February 25, 2025

Record last verified: 2024-10

Locations