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

Abdominal Pain Disorders Functional in Children: Impact of Hypno-analgesia on the Autonomic Balance. A Prospective Single-center Study

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.

Study Overview

• Status: Terminated
• Conditions: Abdominal Pain; Child

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • Centre Hospitalier Universitaire de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Indices of autonomic nervous system in a pediatric population with Abdominal pain disorders functional

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
high frequency	measured with the holter	One month after the hypno-analgesic therapeutic program

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Hugues PATURAL, MD PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2017
• Primary Completion (ACTUAL): January 31, 2019
• Study Completion (ACTUAL): May 29, 2019

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (ESTIMATE): July 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Hypnosis; Nervous System; Electrocardiography, Ambulatory; Abdominal pain disorders functional
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Somatoform Disorders
• Other Study ID Numbers: 1608081; 2016-A00868-43 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No