Clinical trial NCT02830698: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Child
Abdominal Pain
Keywords: Nervous System
Hypnosis
Electrocardiography, Ambulatory
Abdominal pain disorders functional
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 8
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indices of autonomic nervous system in a pediatric population with Abdominal pain disorders functional

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.


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.

Primary outcomes:
measure: high frequency
timeFrame: One month after the hypno-analgesic therapeutic program
Secondary outcomes:
measure: composite score of Francis
timeFrame: One month after the hypno-analgesic therapeutic program
measure: Pediatric Quality of Life inventory
timeFrame: One month after the hypno-analgesic therapeutic program
measure: a chronic abdominal pain scale
timeFrame: One month after the hypno-analgesic therapeutic program
measure: a severity of functional dyspepsia scale
timeFrame: One month after the hypno-analgesic therapeutic program
measure: a severity of abdominal migraine scale
timeFrame: One month after the hypno-analgesic therapeutic program
measure: SDNN (standard deviation of all NN intervals)
timeFrame: One month after the hypno-analgesic therapeutic program
measure: SDANN (standard deviation of the averages of NN intervals in all 5 min segments of the entire recording)
timeFrame: One month after the hypno-analgesic therapeutic program
measure: RMSSD (the square root of the mean of the sum of the squares of difference between adjacent NN intervals)
timeFrame: One month after the hypno-analgesic therapeutic program
measure: pNN50 (the number of pairs of adjacent NN intervals differing by more than 50 ms dived by the total number of all NN intervals)
timeFrame: One month after the hypno-analgesic therapeutic program
measure: TP (total power)
timeFrame: One month after the hypno-analgesic therapeutic program
measure: VLF (very low frequency component)
timeFrame: One month after the hypno-analgesic therapeutic program
measure: LF (low frequency component)
timeFrame: One month after the hypno-analgesic therapeutic program
measure: ratio LF/ HF
timeFrame: One month after the hypno-analgesic therapeutic program
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Hugues PATURAL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: