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The INJECT study - effect of a self-management intervention on needle fear in adults receiving haemodialysis.

Improving Management of Needle Distress during the Journey to Dialysis through Psychological EduCation and Training – The INJECT study (feasibility pilot).

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000229875
Acronym
The INJECT study
Enrollment
10
Registered
2021-03-04
Start date
2021-03-17
Completion date
2021-11-02
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The INJECT pilot feasibility study is comprised of a patient self-management psychological intervention to address needle distress in adults receiving haemodialysis foe end stage kidney failure. the intervention is based on Cognitive Behavioural Therapy (CBT) principles and it consists of 6 learning modules which will provide strategies patients can apply to manage needle distress. There is also an option to use virtual reality (VR) technology as a distraction during dialysis. Patients will be supported by nurse practitioners and a research officer during the intervention. The goal is for patients to feel empowered in self-managing needle distress and to have access to tools/resources that will support skill building and be available to them as needed for revision and reinforcement of learning. This structured and novel intervention enhancing patient self-management and empowerment represents a major advance in addressing needle fear and reducing this aspect of the psychological burden experienced by dialysis patients. It can be translated rapidly into clinical practice and may benefit other patients receiving frequent needles as part of therapy, for example for cancer. It is inexpensive and feasible to deliver across sites. Partnership with patients and nurses at all stages ensures the intervention is useful and successfully implemented into clinical care.

Interventions

This pilot is a patient self-management intervention (INJECT) designed to empower patients to self-manage needle distress and to evaluate the feasibility and acceptability of the INJECT intervention. The intervention is based on Cognitive Behavioural Therapy (CBT) principles and it consists of: 1. Psychologist review to assess participant’s suitability for the intervention Patients eligible for the study will have a consult with the psychologist (face to face, or via telehealth) who will perform

This pilot is a patient self-management intervention (INJECT) designed to empower patients to self-manage needle distress and to evaluate the feasibility and acceptability of the INJECT intervention. The intervention is based on Cognitive Behavioural Therapy (CBT) principles and it consists of: 1. Psychologist review to assess participant’s suitability for the intervention Patients eligible for the study will have a consult with the psychologist (face to face, or via telehealth) who will perform brief psychological assessment, and administer several questionnaires to confirm suitability for the intervention. The psychologist will also provide an overview of the CBT self-management modules and inform patients that the research officer will invite them via email to participate in an online learning program, which they can access via smart phone, laptop, iPad etc. 2. Psychoeducation about needle distress and strategies patients can apply to manage this delivered via an online learning platform 'Open Learning'. Program contains of 6 modules that are completed in 6 weeks at a rate of 1 module/week or faster. Each module takes 10-15 minutes to complete. Modules will contain written text, images, short videos and short activities. Website analytics before and after surveys will be used to assess the feasibility and acceptability to the intervention. The educational material included in the intervention is designed for this study based on the Cognitive Behavioural principles. 3. Option to use virtual reality (VR) technology as distraction during dialysis The psychologist will also inform the patient of the option to use Virtual Reality (VR) technology (as distraction) at dialysis during cannulation and have the headset in the consult for the patient to trial. Should the patient wish to use this in addition to completing the CBT modules, the psychologist will inform the Research officer of this, who will then inform the Nurse Unit Manager/nurse champion of the study at the patient’s dialysis site to coordinate delivery of VR at their subsequent dialysis sessions. VR goggles will have short relaxation videos (river, beach, nature videos) downloaded to help patients either during the cannulation process (needle insertion) or longer depending on their preference. 4. Support by practitioner nurses who have completed INJECT Nurse Education program Nurse practitioners who have also completed the nurse education program on Central Adelaide Local Health Network Learning Central (entitled- INJECT Nurse Education Program) will be available to support patients. 5. Weekly contact by the research officer to discuss progress and address any concerns or issues The duration of the intervention is 6 weeks. The goal of the intervention is to empower patients in self managing needle distress and to have access to tools/resources that will support skill building and be available to them as needed for revision and reinforcement of learning.

Sponsors

Royal Adelaide Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Cohort is selected through dialysis physicians and nursing staff at Central and Northern Adelaide Renal and Transplantation Service (CNARTS) as those identified with high clinical index of suspicion to needle distress. Inclusion criteria: • >18 years • English speaking • Commencing haemodialysis within study timeframe (incident patients) • Already receiving haemodialysis • Current AV fistula • In-patient or outpatient • DFIQ score >2

Exclusion criteria

• Unable to give written consent • Currently receiving psychological therapy/intervention for needle fear/distress • Inability or unwillingness to complete patient self-management modules (e.g. due to literacy, vision impairment, cognitive deficits) • DFIQ less than or equal to 2

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026