ChildNCT02830698
Abdominal Pain Disorders Functional in Children: Impact of Hypno-analgesia on the Autonomic Balance
An observational study of Child and Abdominal Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Child, Abdominal Pain
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2017to 29 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Indices of autonomic nervous system in a pediatric population with Abdominal pain disorders functional
Who may be able to join
- Parents affiliates or entitled to a social security scheme
- Consent form signed by the holder of parental authority
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Saint Etienne
Saint-Etienne, 42055
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Abdominal Pain, Neurologic Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
high frequency
measured with the holter
Measured: One month after the hypno-analgesic therapeutic program
Secondary outcomes (13)
composite score of Francis
severity scale of syndrome (pain intensity)
Measured: One month after the hypno-analgesic therapeutic program
Pediatric Quality of Life inventory
Measured: One month after the hypno-analgesic therapeutic program
a chronic abdominal pain scale
adaptation of Francis composite scale for chronic abdominal pain
Measured: One month after the hypno-analgesic therapeutic program
a severity of functional dyspepsia scale
adaptation of Francis composite scale for functional dyspepsia
Measured: One month after the hypno-analgesic therapeutic program
a severity of abdominal migraine scale
adaptation of Francis composite scale for abdominal migraine
Measured: One month after the hypno-analgesic therapeutic program
SDNN (standard deviation of all NN intervals)
measured with the holter
Measured: 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
Measured: 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
Measured: 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
Measured: One month after the hypno-analgesic therapeutic program
TP (total power)
measured with the holter
Measured: One month after the hypno-analgesic therapeutic program
VLF (very low frequency component)
measured with the holter
Measured: One month after the hypno-analgesic therapeutic program
LF (low frequency component)
measured with the holter
Measured: One month after the hypno-analgesic therapeutic program
ratio LF/ HF
measured with the holter
Measured: One month after the hypno-analgesic therapeutic program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start31 May 2017
- Primary completion31 Jan 2019
- Study completion29 May 2019
Why it stopped: Recruitment difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues PATURAL, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830698
- Sponsor's protocol ID
- 1608081
- Other IDs
- 2016-A00868-43
- Status last verified
- Nov 2022
- First submitted
- 21 Jun 2016
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Pain Disorders Functional in Children: Impact of Hypno-analgesia on the Autonomic Balance. A Prospective Single-center Study
- ClinicalTrials.gov ID
- NCT02830698
- Acronym / sponsor ID
- 1608081
- Conditions
- Child, Abdominal Pain
- Keywords
- Nervous System, Hypnosis, Electrocardiography, Ambulatory, Abdominal pain disorders functional
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Indices of autonomic nervous system in a pediatric population with Abdominal pain disorders functional
Key inclusion criteria (2 listed)
- Parents affiliates or entitled to a social security scheme
- Consent form signed by the holder of parental authority
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
high frequency
Time frame: One month after the hypno-analgesic therapeutic program
measured with the holter
13 secondary outcomes
composite score of Francis
Time frame: One month after the hypno-analgesic therapeutic program
Pediatric Quality of Life inventory
Time frame: One month after the hypno-analgesic therapeutic program
a chronic abdominal pain scale
Time frame: One month after the hypno-analgesic therapeutic program
a severity of functional dyspepsia scale
Time frame: One month after the hypno-analgesic therapeutic program
a severity of abdominal migraine scale
Time frame: One month after the hypno-analgesic therapeutic program
SDNN (standard deviation of all NN intervals)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: One month after the hypno-analgesic therapeutic program
TP (total power)
Time frame: One month after the hypno-analgesic therapeutic program
VLF (very low frequency component)
Time frame: One month after the hypno-analgesic therapeutic program
LF (low frequency component)
Time frame: One month after the hypno-analgesic therapeutic program
ratio LF/ HF
Time frame: One month after the hypno-analgesic therapeutic program
Results and safety
The study was stopped early (reason given: Recruitment difficulties.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugues PATURAL, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child and Abdominal Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high frequency (time frame: One month after the hypno-analgesic therapeutic program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.