Patient experience of injections in age-related macular degeneration
Research type
Research Study
Full title
Investigation of pain and discomfort associated with anti-VEGF injections
IRAS ID
245666
Contact name
Ashley Wood
Contact email
Sponsor organisation
Research and Innovation Services, Cardiff University
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Summary of Research
Age-related macular degeneration (AMD) is a progressive disease of the retina that affects central vision. Sufferers with neovascular AMD can be treated with (intravitreal) injections into the eye, however some patients report experiencing pain and discomfort during or after the treatment. These were cited as important issues to patients receiving injections that can be both a cause and consequence of anxiety, and are important contributors to their wellbeing and quality of life. We believe that patient experiences have not been satisfactorily investigated with respect to the individual’s perspective. We will evaluate pain/discomfort and anxiety to better understand the experiences of patients receiving injections and the impact on their compliance with treatment and wellbeing.This is an observational cross-sectional study using a mixed methods approach. Patients with neovascular AMD who are receiving intravitreal injections at the University Hospital Wales (UHW) will be eligible to take part in the study.
At the outset of the study, interviews with patients (Part 1 Patient Experiences – up to 1 hr) will be conducted at the Cardiff School of Optometry and Vision Sciences/participant’s own home, concurrently with practitioner interviews (Part 2 Practitioner Experiences – up to 30 mins) at the UHW. This will aid understanding of the most important factors associated with patient experiences and identify routine treatment procedures. A hypothesis will be generated based on these findings. Part 3 Experience of Individual Treatments involves evaluating pain/discomfort, anxiety and wellbeing using subjective and objective measures, an open-ended question to measure compliance with treatment, as well as imaging of the injection site characteristics. This will take place at the UHW (up to 1.5 hrs).
Identifying factors that cause pain/discomfort or anxiety may allow modification of the injection procedures to improve patient experience and encourage them to continue treatment. This study is being funded by The Abbeyfield Research Foundation.
Summary of Results
This research project aimed to investigate the experiences of patients undergoing injections of Anti-Vascular Endothelial Growth Factors (Anti-VEGF) for neovascular age-related macular degeneration (AMD) associated with pain and the impact on patient adherence and wellbeing, and to explore the factors that contribute to painful experiences. The project was also amended to consider these experiences in relation to the coronavirus (covid-19) which occurred during the study period.This research project consisted of 4 studies, with a total of 103 participants recruited as follows:
• Part 1 Patient experiences (n=14 patients with neovascular AMD) of previous injections based on face-to-face semi-structured interviews.
• Part 2 Practitioner experiences (n=7 practitioners) of previous injections delivered based on face-to-face semi-structured interviews.
• Part 3 Patient experience of individual treatments (n=65 patients with neovascular AMD) assess by observation of injection and recording of electrodermal activity, an objective measure of pain and anxiety experienced, alongside self-report questionnaires addressing pain, anxiety and wellbeing undertaken before, at 1-2 and 24 hours after the treatment.
• Part 4 Patient experiences of injections undertaken during COVID-19 (n=17 patients with neovascular AMD) based on semi-structured interviews conducted by telephone.Summary of results for Part 1 & Part 2:
• Patients experienced prolonged soreness and irritation of up to 36 hours following most anti-VEGF injections, now recognised as more common than previously thought.• Build-up of anxiety and apprehension were commonly reported at the early stages of the treatment course, however some patients felt apprehensive every time they underwent treatment.
• Effective patient-practitioner communication helps patients to recognise the severity of untreated neovascular AMD and supports their adherence to treatment.
Summary of results for Part 3:
• Phasic electrodermal activity was significantly higher during intravitreal injection (insertion of needle and delivery of the anti-VEGF solution).• Questionnaire data reported that at 24 hours post-treatment, 4.7% of participants continued to experience severe sharp, aching or tender pain, and 15.6% reported feeling a moderate tiring-exhausting pain.
• Multiple linear regression identified the injection skin conductance response (SCR) amplitude, type of anti-VEGF (aflibercept), state anxiety at baseline and same-day bilateral injections as the most significant predictor variables of pain at 1-2 hours post-treatment, F(4,51) = 8.99, p = 1.47e-05, explaining 38% of the variance in the model.
• The injection SCR amplitude was the most significant predictor variable of pain at both 1-2 hours and 24 hours post-treatment.
Summary of results for Part 4:
• Patients experienced vision deterioration and felt more vulnerable to loss of independence and mobility.• Isolation and social distancing have resulted in patients with co-existing AMD and other chronic conditions feeling lonely and depressed.
• COVID-19 risks have not influenced patients adhering to their injections, instead they expressed concerns and felt anxious and terrified of losing sight due to lack of timely treatment.
• Undermanaged pain greatly impacts patients’ experiences as long-term administration of injections are commonly needed. Practitioners should assess and control pain during and immediately after injection and convey consistent guidance to patients to self-manage their pain.
Integrating these findings with individual perspectives captured a comprehensive understanding of the emotional and physical qualities of pain. Adherence to treatment was a key priority for patients over pain and COVID-19 health risks. Pain during and following injections may inform clinical practice on implementing pain assessment tools, providing consistent verbal instructions to patients on avoiding contact with the injected eye and advising them on specific pain relief techniques, including topical ice application to self-manage their pain at home. High injection SCR amplitudes and baseline state anxiety may also inform clinical practice on assessing patients’ anxiety at regulated intervals and advising on nurturing self-talk and relaxation techniques to manage their apprehension. Engaging communications to reassure and strengthen patient confidence in their treatment course are meaningful and valuable qualities to patients receiving intravitreal injections.
REC name
Wales REC 2
REC reference
19/WA/0004
Date of REC Opinion
18 Jan 2019
REC opinion
Favourable Opinion