Impact of Hypnosis on Pain Management During Dialysis on Patients Suffering From Arterial Disease

NCT ID: NCT02844348

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-10-31

Brief Summary

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard pain control

Classical pain assessment and drug treatment at each dialysis session.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hypnosis

Besides the classical pain assessment and drug treatment, hypnosis sessions during 2 periods of one week of dialysis sessions.

Group Type: EXPERIMENTAL

Hypnosis session

Intervention Type: OTHER

Interventions

Hypnosis session

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hemodialysis Unit University Hospital Grenoble

Grenoble, , France

Countries

France

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Other Identifiers

ID/RCB : 2015-A00921-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

38RC15.176

Identifier Type: -

Identifier Source: org_study_id