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

NCT02830698 | Terminated

• 2 other identifiers: 16080812016-A00868-43
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Child; Abdominal Pain

Keywords

Nervous System; Hypnosis; Electrocardiography, Ambulatory; Abdominal pain disorders functional

Outcome Measures

Primary Outcomes (1)

• high frequency

  measured with the holter

  One month after the hypno-analgesic therapeutic program

Secondary Outcomes (13)

• composite score of Francis

  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

  One month after the hypno-analgesic therapeutic program

• a severity of functional dyspepsia scale

  One month after the hypno-analgesic therapeutic program

• a severity of abdominal migraine scale

  One month after the hypno-analgesic therapeutic program

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Parents affiliates or entitled to a social security scheme
• Consent form signed by the holder of parental authority

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Abdominal Pain; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Pain; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Nervous System Diseases

Study Officials

• Hugues PATURAL, MD PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 13, 2016
• Study Start: May 31, 2017
• Primary Completion: January 31, 2019
• Study Completion: May 29, 2019
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)