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

Terminated

• Conditions: Abdominal Pain; Child

• Registration Number: NCT02830698
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-13
• Study Start: 2017-05-31
• Primary Completion: 2019-01-31
• Study Completion: 2019-05-29
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
high frequency	One month after the hypno-analgesic therapeutic program	measured with the holter

Secondary Outcome Measures

Name	Time	Method
a severity of abdominal migraine scale	One month after the hypno-analgesic therapeutic program	adaptation of Francis composite scale for abdominal migraine
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	measured with the holter
VLF (very low frequency component)	One month after the hypno-analgesic therapeutic program	measured with the holter
a severity of functional dyspepsia scale	One month after the hypno-analgesic therapeutic program	adaptation of Francis composite scale for functional dyspepsia
ratio LF/ HF	One month after the hypno-analgesic therapeutic program	measured with the holter
composite score of Francis	One month after the hypno-analgesic therapeutic program	severity scale of syndrome (pain intensity)
a chronic abdominal pain scale	One month after the hypno-analgesic therapeutic program	adaptation of Francis composite scale for chronic abdominal pain
SDNN (standard deviation of all NN intervals)	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)	One month after the hypno-analgesic therapeutic program	measured with the holter
LF (low frequency component)	One month after the hypno-analgesic therapeutic program	measured with the holter
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	measured with the holter
TP (total power)	One month after the hypno-analgesic therapeutic program	measured with the holter

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Saint Etienne; 🇫🇷 Saint Etienne, France