PainHYPNODIALNCT02844348
Impact of Hypnosis on Pain Management During Dialysis on Patients Suffering From Arterial Disease
A study testing Hypnosis session in people with Pain, run by University Hospital, Grenoble at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Hypnosis session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read more
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
- Being tested
- Hypnosis session
- Keywords
- Pain, Hypnosis, Chronic Dialysis, Arterial Disease
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis sessionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hypnosis session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 60 sec
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionOct 2016
Why it stopped: Enrollment problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844348
- Sponsor's protocol ID
- 38RC15.176
- Other IDs
- ID/RCB : 2015-A00921-48
- Acronym
- HYPNODIAL
- Status last verified
- Oct 2016
- First submitted
- 30 May 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Labeeuw M, Merono Nombret A, Boyer S, Guillermin MN. Rapport du Rein Rhone Alpes Année 2012. Agence de la Biomedicine, Coordination Nationale REIN.
Pernod G, Bosson JL, Golshayan D, Barro C, Alloatti S, Turc-Baron C, Quarello F, Jeantet A, Von Albertini B, Foret M, Lauren G, Cordonnier D, Piccoli G, Wauters JP; Diamant Alpin Collaborative Dialysis Study Group. The Diamant Alpin Dialysis cohort study: clinico-biological characteristics and cardiovascular genetic risk profile of incident patients. J Nephrol. 2004 Jan-Feb;17(1):66-75.
PubMed 15151261Rüger. Prise en charge de la douleur dans l'ischémie chronique des membres inferieurs Pain 2008 Septembre 30 139 (1) 2 : 201-208
Santoro D, Satta E, Messina S, Costantino G, Savica V, Bellinghieri G. Pain in end-stage renal disease: a frequent and neglected clinical problem. Clin Nephrol. 2013 Jan;79 Suppl 1:S2-11.
PubMed 23249527Murtagh FE, Addington-Hall J, Higginson IJ. The prevalence of symptoms in end-stage renal disease: a systematic review. Adv Chronic Kidney Dis. 2007 Jan;14(1):82-99. doi: 10.1053/j.ackd.2006.10.001.
PubMed 17200048Bioy A. Traiter la douleur par l'hypnose. Cahier scientifique AFIDTN 2010 Dec, N°93 : 13-15.
Le choix de l'hypnose pour soulager la douleur. Institut Upsa de la Douleur. La Douleur N°7 des recommandations à la pratique Mars 2009.
Elkins G, Jensen MP, Patterson DR. Hypnotherapy for the management of chronic pain. Int J Clin Exp Hypn. 2007 Jul;55(3):275-87. doi: 10.1080/00207140701338621.
PubMed 17558718Dillworth T, Mendoza ME, Jensen MP. Neurophysiology of pain and hypnosis for chronic pain. Transl Behav Med. 2012 Mar;2(1):65-72. doi: 10.1007/s13142-011-0084-5.
PubMed 24073099Jensen M, Patterson DR. Hypnotic treatment of chronic pain. J Behav Med. 2006 Feb;29(1):95-124. doi: 10.1007/s10865-005-9031-6. Epub 2006 Jan 11.
PubMed 16404678Iserson KV. An hypnotic suggestion: review of hypnosis for clinical emergency care. J Emerg Med. 2014 Apr;46(4):588-96. doi: 10.1016/j.jemermed.2013.09.024. Epub 2014 Jan 25.
PubMed 24472351Kekecs Z, Varga K. Positive suggestion techniques in somatic medicine: A review of the empirical studies. Interv Med Appl Sci. 2013 Sep;5(3):101-11. doi: 10.1556/IMAS.5.2013.3.2. Epub 2013 Sep 16.
PubMed 24265899Editorial. Comfortably numb. The Association of Anaesthetists of Great Britain and Ireland 2013 ;Vol 68 : 896-898.
Communication Journées de Néphrologie. Prouteau-Chartier M. Hypnoanalgésie en Hémodialyse chronique. Quibéron 2012
Haute Autorite de Sante. [Management of chronic lower-limb obliterative atherosclerosis (indications for drug treatment, revascularisation and physiotherapy). Professional Guidelines Department - April 2006]. Ann Dermatol Venereol. 2007 Feb;134(2):199-206. doi: 10.1016/s0151-9638(07)91621-x. No abstract available. French.
PubMed 17375025
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hypnosis on the Management of Chronic and Breakthrough Pain of Chronic Dialysis Patients Suffering From Arterial Disease
- ClinicalTrials.gov ID
- NCT02844348
- Acronym / sponsor ID
- HYPNODIAL / 38RC15.176
- Conditions
- Pain
- Keywords
- Pain, Hypnosis, Chronic Dialysis, Arterial Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment problem
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard pain control | No intervention | –Classical pain assessment and drug treatment at each dialysis session. |
| Hypnosis | Experimental | Other: Hypnosis sessionBesides the classical pain assessment and drug treatment, hypnosis sessions during 2 periods of one week of dialysis sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Minors.
- Patients protected by law (under guardianship, deprived of liberty ...).
- Pregnant women.
- Refusal
- Patients not understanding French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosis session | Other | Hypnosis |
Primary outcome
Evaluation of pain intensity when hypnosis is applied during dialysis
Time frame: up to 60 sec
Pain is evaluate with a scale : Visual Analogue Pain Scale (VAPS) according to patients impression.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- BackgroundLabeeuw M, Merono Nombret A, Boyer S, Guillermin MN. Rapport du Rein Rhone Alpes Année 2012. Agence de la Biomedicine, Coordination Nationale REIN.
- Background: PubMed 15151261Pernod G, Bosson JL, Golshayan D, Barro C, Alloatti S, Turc-Baron C, Quarello F, Jeantet A, Von Albertini B, Foret M, Lauren G, Cordonnier D, Piccoli G, Wauters JP; Diamant Alpin Collaborative Dialysis Study Group. The Diamant Alpin Dialysis cohort study: clinico-biological characteristics and cardiovascular genetic risk profile of incident patients. J Nephrol. 2004 Jan-Feb;17(1):66-75.
- BackgroundRüger. Prise en charge de la douleur dans l'ischémie chronique des membres inferieurs Pain 2008 Septembre 30 139 (1) 2 : 201-208
- Background: PubMed 23249527Santoro D, Satta E, Messina S, Costantino G, Savica V, Bellinghieri G. Pain in end-stage renal disease: a frequent and neglected clinical problem. Clin Nephrol. 2013 Jan;79 Suppl 1:S2-11.
- Background: PubMed 17200048Murtagh FE, Addington-Hall J, Higginson IJ. The prevalence of symptoms in end-stage renal disease: a systematic review. Adv Chronic Kidney Dis. 2007 Jan;14(1):82-99. doi: 10.1053/j.ackd.2006.10.001.
- BackgroundBioy A. Traiter la douleur par l'hypnose. Cahier scientifique AFIDTN 2010 Dec, N°93 : 13-15.
- BackgroundLe choix de l'hypnose pour soulager la douleur. Institut Upsa de la Douleur. La Douleur N°7 des recommandations à la pratique Mars 2009.
- Background: PubMed 17558718Elkins G, Jensen MP, Patterson DR. Hypnotherapy for the management of chronic pain. Int J Clin Exp Hypn. 2007 Jul;55(3):275-87. doi: 10.1080/00207140701338621.
- Background: PubMed 24073099Dillworth T, Mendoza ME, Jensen MP. Neurophysiology of pain and hypnosis for chronic pain. Transl Behav Med. 2012 Mar;2(1):65-72. doi: 10.1007/s13142-011-0084-5.
- Background: PubMed 16404678Jensen M, Patterson DR. Hypnotic treatment of chronic pain. J Behav Med. 2006 Feb;29(1):95-124. doi: 10.1007/s10865-005-9031-6. Epub 2006 Jan 11.
- Background: PubMed 24472351Iserson KV. An hypnotic suggestion: review of hypnosis for clinical emergency care. J Emerg Med. 2014 Apr;46(4):588-96. doi: 10.1016/j.jemermed.2013.09.024. Epub 2014 Jan 25.
- Background: PubMed 24265899Kekecs Z, Varga K. Positive suggestion techniques in somatic medicine: A review of the empirical studies. Interv Med Appl Sci. 2013 Sep;5(3):101-11. doi: 10.1556/IMAS.5.2013.3.2. Epub 2013 Sep 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis session in people with Pain, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain intensity when hypnosis is applied during dialysis (time frame: up to 60 sec). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02844348, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.