Abdominal Pain Disorders Functional in Children: Impact of Hypno-analgesia on the Autonomic Balance. A Prospective Single-center Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Child
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- high frequency
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
high frequency
Time Frame: One month after the hypno-analgesic therapeutic program
measured with the holter
Secondary Outcomes
- VLF (very low frequency component)(One month after the hypno-analgesic therapeutic program)
- a severity of abdominal migraine scale(One month after the hypno-analgesic therapeutic program)
- RMSSD (the square root of the mean of the sum of the squares of difference between adjacent NN intervals)(One month after the hypno-analgesic therapeutic program)
- a severity of functional dyspepsia scale(One month after the hypno-analgesic therapeutic program)
- ratio LF/ HF(One month after the hypno-analgesic therapeutic program)
- composite score of Francis(One month after the hypno-analgesic therapeutic program)
- a chronic abdominal pain scale(One month after the hypno-analgesic therapeutic program)
- SDNN (standard deviation of all NN intervals)(One month after the hypno-analgesic therapeutic program)
- pNN50 (the number of pairs of adjacent NN intervals differing by more than 50 ms dived by the total number of all NN intervals)(One month after the hypno-analgesic therapeutic program)
- LF (low frequency component)(One month after the hypno-analgesic therapeutic program)
- Pediatric Quality of Life inventory(One month after the hypno-analgesic therapeutic program)
- SDANN (standard deviation of the averages of NN intervals in all 5 min segments of the entire recording)(One month after the hypno-analgesic therapeutic program)
- TP (total power)(One month after the hypno-analgesic therapeutic program)