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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02844348

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Other: Hypnosis session	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of Hypnosis on the Management of Chronic and Breakthrough Pain of Chronic Dialysis Patients Suffering From Arterial Disease

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard pain control Classical pain assessment and drug treatment at each dialysis session.
Experimental: Hypnosis Besides the classical pain assessment and drug treatment, hypnosis sessions during 2 periods of one week of dialysis sessions.	Other: Hypnosis session

Arm

Intervention/Treatment

No Intervention: Standard pain control

Classical pain assessment and drug treatment at each dialysis session.

Experimental: Hypnosis

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

Other: Hypnosis session

Outcome Measures

Primary Outcome Measures

Evaluation of pain intensity when hypnosis is applied during dialysis [up to 60 sec]
Pain is evaluate with a scale : Visual Analogue Pain Scale (VAPS) according to patients impression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hemodialysis Unit University Hospital Grenoble	Grenoble		France	38043

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT02844348

Other Study ID Numbers:

38RC15.176
ID/RCB : 2015-A00921-48

First Posted:

Jul 26, 2016

Last Update Posted:

Oct 7, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by University Hospital, Grenoble

Study Results

No Results Posted as of Oct 7, 2016