Chronic Pain in Patients in Hemodialysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCardenal Herrera University
About this trial
Pain is one of the most common symptoms among patients with End Stage Renal Disease (ESRD), and often goes unrecognized or inadequately managed in hemodialysis patients. More than 50% of patients undergoing hemodialysis suffer from pain, with 75% of them being treated ineffectively due to healthcare professionals\' lack of awareness of this symptom. Therefore, pain management in this population is a complex and challenging task for healthcare providers. The most prevalent pain syndromes in hemodialysis patients include musculoskeletal disorders, metabolic neuropathies, in addition to typical intradialytic pain.
The aim of this study is to assess the presence and characteristics of chronic pain in patients with ESRD undergoing hemodialysis to determine whether it is relevant to include the management of chronic pain in the holistic treatment (physical activity, nutrition, and psychological support) already being implemented in various studies for these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with End-Stage Renal Disease (ESRD)
Have been on hemodialysis treatment for at least 3 months and are medically stable.
Able to walk a few steps, even if they require walking aids such as canes or walkers.
Disqualifiers
Myocardial infarction in the past 6 weeks.
Unstable angina during exercise or at rest.
Amputation of lower limbs above the knee without prosthetics.
Cerebrovascular disease such as stroke or transient ischemic attacks in the last 6 months or with significant sequelae affecting lower limb mobility.
Trial population
Patients selected by Nephrologists in different Hemodialysis units collaborating in the current project, which includes holistic treatment through non-immersive virtual reality both at the dialysis center and at home, will be invited to participate in this study. Patients from different Hemodialysis units (Hospital de Manises and with approval from the Clinical Research Ethics Committee (CEIC) at the Consorcio Sanitario de Terrassa) and patients who are part of the renal patient association ALCER España (Association for the Fight against Kidney Diseases) will also be selected.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 1 trial groupGroup A: Participant with CKD
Trial outcomes
Primary outcomes
1
Stress level assessed by the salivary cortisol test
Higher stress present higher cortisol levels
Time frame
Baseline2
Stress level assessed by the perceived stress scale (PSS)
The minimal score is 0. The maximum PSS score is 56. The higher score obtained, the higher stress level
Time frame
BaselineSecondary outcomes
1
Self- efficacy assessed by questionnaire
The minimal score is 0. The maximun Self-efficacy score is 40. The lower score obtained , the lower self-efficacy
Time frame
Baseline2
Quality of sleep assessed by Pittsburgh Sleep Quality Index
The minimal score is 0. The maximun quality index score is 21. The higher score obtained, the lower quality of sleep
Time frame
Baseline3
The impact of headaches on life assessed by Headache Impact Test-6
The minimal score is 0. The maximun Headache Impact Test-6 score is 79. The higher score obtained, the higher impact of headaches on life
Time frame
Baseline4
Anxiety and depression assessed by Hospital anxiety and depression scale (HADS)
The minimal score is 0. The cutoff point for the two subscales, anxiety and depression, is 8 and \< 10. The higher score obtained, The higher impact of anxiety and depression levels on life.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cardenal Herrera University
Lead sponsor
Consorci Sanitari de Terrassa
Collaborator
Source ClinicalTrials.gov