Perspective of Healthcare Professionals Haemodialysis NeedlingNCT06845605
Behind the Needle: Healthcare Professionals' Perspectives on HD Needling
An observational study of Perspective of Healthcare Professionals Haemodialysis Needling and Dialysis, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perspective of Healthcare Professionals Haemodialysis Needling, Dialysis
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2024to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- •Registered nurses or healthcare assistants who do not perform needling procedures in a haemodialysis unit will not be eligible to participate.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG1 4AB
Eunice Doctolero
About this study
Official title: A Qualitative Exploration Study of Healthcare Professionals' Perspectives in Haemodialysis Needling to Enhance Patients' Overall Experience
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.
- Keywords
- Haemodialysis, Haemodialysis needling, End-Stage Renal Disease, Fistula, Cannulation
- Medical subject headings
- Kidney Failure, Chronic, Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start30 Oct 2024
- Primary completion31 Jan 2025
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Perspective of Healthcare Professionals Haemodialysis NeedlingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845605
- Sponsor's protocol ID
- RD2024-55
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26157184Manoochehri 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.
PubMed 28316703Hagerty 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.
PubMed 28899257Duncanson 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.
PubMed 38106606Rahmah 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.
PubMed 35244357Napalkov 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.
PubMed 24131509Alsbrooks 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.
PubMed 36409734Hill 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.
PubMed 31423945Lamb 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.
PubMed 29929090Fielding 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.
PubMed 35034481Bello 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.
PubMed 35194215
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Exploration Study of Healthcare Professionals' Perspectives in Haemodialysis Needling to Enhance Patients' Overall Experience
- ClinicalTrials.gov ID
- NCT06845605
- Acronym / sponsor ID
- RD2024-55
- Keywords
- Haemodialysis, Haemodialysis needling, End-Stage Renal Disease, Fistula, Cannulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- •Registered nurses or healthcare assistants who do not perform needling procedures in a haemodialysis unit will not be eligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: March 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 26157184Sutton 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.
- Background: PubMed 28316703Manoochehri 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.
- Background: PubMed 28899257Hagerty 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.
- Background: PubMed 38106606Duncanson 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.
- Background: PubMed 35244357Rahmah 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.
- Background: PubMed 24131509Napalkov 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.
- Background: PubMed 36409734Alsbrooks 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.
- Background: PubMed 31423945Hill 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.
- Background: PubMed 29929090Lamb 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.
- Background: PubMed 35034481Fielding 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.
- Background: PubMed 35194215Bello 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.
- Moore, C., Ellis-Caird, H., Fielding, C., et al. (2024). Patients' perspectives on key aspects influencing needling for haemodialysis: A qualitative study. Manuscript in preparationLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006;3(2):77-101Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perspective of Healthcare Professionals Haemodialysis Needling and Dialysis, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eunice Ann Doctolero, Bachelor of Science in Nursing (+447737044516, eunice.doctolero@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: March 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06845605, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.