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

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02830698
• Other study ID #: 1608081
• Secondary ID: 2016-A00868-43
• Status: Terminated
• Start date: May 31, 2017
• Est. completion date: May 29, 2019

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 29, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Child
• Somatoform Disorders

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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