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

NCT02844348 | Withdrawn

• 2 other identifiers: 38RC15.176ID/RCB : 2015-A00921-48
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Pain; Hypnosis; Chronic Dialysis; Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard pain control

NO INTERVENTION

Classical pain assessment and drug treatment at each dialysis session.

Hypnosis

EXPERIMENTAL

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

Other: Hypnosis session

Interventions

Hypnosis session OTHER

Hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Hemodialysis Unit University Hospital Grenoble

Grenoble, 38043, France

Location

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  BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: July 26, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 7, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)