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Abdominal Pain Disorders Functional in Children: Impact of Hypno-analgesia on the Autonomic Balance

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ClinicalTrials.gov Identifier: NCT02830698
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

Abdominal pain disorders functional (including functional dyspepsia, irritable bowel syndrome, abdominal migraine, functional abdominal pain) is a very common disease in the pediatric population, where classical medical treatment does not always prove effective. This clinical entity has an impact on the individual physiological balance particularly on the autonomic regulation. Studies concerning adults with irritable bowel syndrome, showed significant changes in heart rate variability indices (HRV: heart rate variability).

The study of time and frequency domain analysis of HRV allows noninvasive and reproducible assessment of the cardiac sympathetic and parasympathetic tone.

The investigators hypothesize that the sympathovagal balance could be altered in children in case of prolonged nociceptive stress as the investigators find it especially in irritable bowel syndrome and functional abdominal pain. In recent years, the control of pediatric pain experienced considerable growth through hypnosis techniques and several studies have shown analgesic efficacy with a beneficial effect in terms of quality of life in children.

Our study aims to assess the impact of the hypno-analgesia treatment of Abdominal pain disorders functional on sympathovagal balance. The investigators propose to realize in 7 to 18 years old children with Abdominal pain disorders functional a single center prospective study to highlight after a standardized hypnosis program, changes in the time and frequency domain indices of heart rate variability and clinical or quality of life parameters. The primary endpoint will be the high frequency HF indice. Secondary endpoints will be the other indices of HRV (Ptot, VLF, LF, ratio LF / HF, SDNN, SDANN, pNN50, RMSSD), the Quality of Life Questionnaire values (PedsQL ™ 4.0) a pain scale and the composite score of Francis.


Condition or disease
Child Abdominal Pain

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abdominal Pain Disorders Functional in Children: Impact of Hypno-analgesia on the Autonomic Balance. A Prospective Single-center Study
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain




Primary Outcome Measures :
  1. high frequency [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter


Secondary Outcome Measures :
  1. composite score of Francis [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    severity scale of syndrome (pain intensity)

  2. Pediatric Quality of Life inventory [ Time Frame: One month after the hypno-analgesic therapeutic program ]
  3. a chronic abdominal pain scale [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    adaptation of Francis composite scale for chronic abdominal pain

  4. a severity of functional dyspepsia scale [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    adaptation of Francis composite scale for functional dyspepsia

  5. a severity of abdominal migraine scale [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    adaptation of Francis composite scale for abdominal migraine

  6. SDNN (standard deviation of all NN intervals) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter

  7. SDANN (standard deviation of the averages of NN intervals in all 5 min segments of the entire recording) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter

  8. RMSSD (the square root of the mean of the sum of the squares of difference between adjacent NN intervals) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter

  9. pNN50 (the number of pairs of adjacent NN intervals differing by more than 50 ms dived by the total number of all NN intervals) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter

  10. TP (total power) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter

  11. VLF (very low frequency component) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter

  12. LF (low frequency component) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter

  13. ratio LF/ HF [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Indices of autonomic nervous system in a pediatric population with Abdominal pain disorders functional
Criteria

Inclusion Criteria:

  • Parents affiliates or entitled to a social security scheme
  • Consent form signed by the holder of parental authority

Exclusion Criteria:

  • Child with pathologies reaching the central nervous system or the brain stem.
  • Children with a severe pathology of cardio-respiratory or heart being referred to treatment.
  • Children requiring emergency surgery or trauma or septic or inflammatory context.
  • Children with psychiatric disorders or mental retardation proven.
  • Children who have already used the earlier hypnosis.
  • Children not speaking French language.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830698


Contacts
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Contact: Hugues PATURAL, MD PhD (0)4 77 82 85 42 ext +33 hugues.patural@chu-st-etienne.fr
Contact: Marie PEURIERE (0)4 77 82 92 72 ext +33 marie.peuriere@chu-st-etienne.fr

Locations
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France
Centre Hospitalier Universitaire de Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: Hugues PATURAL, MD PhD    (0)4 77 82 85 42 ext +33    hugues.patural@chu-st-etienne.fr   
Sub-Investigator: Clara CREMILLIEUX, MD         
Sub-Investigator: Sylvie DESTOMBE, MD         
Sub-Investigator: Kareen BILLIEMAZ, MD         
Principal Investigator: Hugues PATURAL, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Hugues PATURAL, MD PhD Centre Hospitalier Universitaire de Saint Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02830698    
Other Study ID Numbers: 1608081
2016‐A00868‐43 ( Other Identifier: ANSM )
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Nervous System
Hypnosis
Electrocardiography, Ambulatory
Abdominal pain disorders functional
Additional relevant MeSH terms:
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Abdominal Pain
Somatoform Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Mental Disorders