Pain Clinical Trial
— HYPNODIALOfficial title:
Impact of Hypnosis on the Management of Chronic and Breakthrough Pain of Chronic Dialysis Patients Suffering From Arterial Disease
A chronic renal disease can results in the development of cardiovascular complications,
including chronic arterial disease ; but a cardiovascular disease may be from a kidney
malfunction that will end in end stage renal disease (ESRD). Two thirds of the chronic
hemodialysis patients taken in charge in Grenoble in the last years suffered from an
arterial disease at a symptomatic stage. Breakthrough pain can appear during the
hemodialysis sessions. These sessions induce sudden hemodynamic changes and a peripheral
vasoconstriction reaction that increases in particular all pain phenomena related to chronic
low limbs ischemia. Therefore, patients have to face pain, sometimes chronic but also
breakthrough pain, during the dialysis sessions, in all its dimensions.
The analgesic balance through the classical drug treatment is extremely complex, as they are
both at risk of overdose and of partial effectiveness. Strict medical treatment remains
unsatisfactory, as it takes into account only the expressions of symptoms during dialysis
sessions, when most of the time pain is already installed and analgesic treatment is not
completely effective.
The combination of classic pharmacological treatment with hypnosis, already used in other
indications (chronic pain, analgesia, depression and anxiety), may mitigate the painful
feeling on patients suffering from arterial disease during the dialysis sessions, with a
beneficial impact on their overall quality of life. There is also evidence to suggest that
hypnosis may be more effective treating neuropathic or vascular pain, those experienced by
our patients, than musculoskeletal pain, like back pain.
Hypnosis is a mind-body approach focused on the subject, and not on the disease or the act
of dialysis. It can be described at the same time as a modified state of consciousness and a
particular intersubjective relation between a practitioner and his patient. The practice of
this kind of hypnoanalgesia by the nurses is particularly relevant in hemodialysis, as the
trust developed during regular chronic treatment can become an asset to shorten the
induction phase and help to install this intersubjective relation.
The high incidence of this complication, the difficulties of current pain management and the
impact on everyday life for the patients, justify the choice of this approach, where more
further research is needed.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Chronic hemodialysis patients, requiring dialysis at least 3 times per week. - Patients rating pain on a Visual analogue scale (VAS) > or = to 3 during hemodialysis sessions for lower limb pain related to chronic arterial disease. - Patients affiliated to a health insurance company. - Patients having consented to participate in the study. Exclusion Criteria: - Minors. - Patients protected by law (under guardianship, deprived of liberty ...). - Pregnant women. - Refusal - Patients not understanding French. - Patients with cognitive, psychotic or behavioral disorders. - Patients with a hearing loss limiting communication. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hemodialysis Unit University Hospital Grenoble | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of pain intensity when hypnosis is applied during dialysis | Pain is evaluate with a scale : Visual Analogue Pain Scale (VAPS) according to patients impression. | up to 60 sec | No |
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