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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

Tracking Information
First Submitted Date June 21, 2016
First Posted Date July 13, 2016
Last Update Posted Date September 27, 2018
Actual Study Start Date May 31, 2017
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2016)
high frequency [ Time Frame: One month after the hypno-analgesic therapeutic program ]
measured with the holter
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 26, 2018)
  • composite score of Francis [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    severity scale of syndrome (pain intensity)
  • Pediatric Quality of Life inventory [ Time Frame: One month after the hypno-analgesic therapeutic program ]
  • a chronic abdominal pain scale [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    adaptation of Francis composite scale for chronic abdominal pain
  • a severity of functional dyspepsia scale [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    adaptation of Francis composite scale for functional dyspepsia
  • a severity of abdominal migraine scale [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    adaptation of Francis composite scale for abdominal migraine
  • SDNN (standard deviation of all NN intervals) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter
  • 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
  • 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
  • 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
  • TP (total power) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter
  • VLF (very low frequency component) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter
  • LF (low frequency component) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter
  • ratio LF/ HF [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter
Original Secondary Outcome Measures
 (submitted: July 12, 2016)
  • composite score of Francis [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    severity scale of syndrome (pain intensity)
  • Pediatric Quality of Life inventory [ Time Frame: One month after the hypno-analgesic therapeutic program ]
  • a pain scale [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    to 0 to 10
  • SDNN (standard deviation of all NN intervals) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter
  • 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
  • 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
  • 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
  • TP (total power) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter
  • VLF (very low frequency component) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter
  • LF (low frequency component) [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter
  • ratio LF/ HF [ Time Frame: One month after the hypno-analgesic therapeutic program ]
    measured with the holter
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Abdominal Pain Disorders Functional in Children: Impact of Hypno-analgesia on the Autonomic Balance
Official Title Abdominal Pain Disorders Functional in Children: Impact of Hypno-analgesia on the Autonomic Balance. A Prospective Single-center Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Indices of autonomic nervous system in a pediatric population with Abdominal pain disorders functional
Condition
  • Child
  • Abdominal Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 12, 2016)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02830698
Other Study ID Numbers 1608081
2016‐A00868‐43 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators Not Provided
Investigators
Principal Investigator: Hugues PATURAL, MD PhD Centre Hospitalier Universitaire de Saint Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date September 2018