Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369753
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Brief Title:
Visible Abdominal Distension
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Tratamiento de la distensión Abdominal Funcional
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Abdominal distention is produced by an abnormal somatic postural tone The authors developed an original biofeedback technique In a randomized placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention However the technique is technically complex and unpractical
Aim To prove the efficacy of a noninstrumental biofeedback technique transmitted by a standard training program for the treatment of abdominal distension in different centers
Selection criteria Episodes of visible abdominal distension Intervention Patients will be randomized into biofeedback and placebo groups Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period
Biofeedback Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment Patients will be instructed to perform the same exercises before and after breakfast lunch and dinner during the 4-week intervention period
Placebo Sham measurements of abdominal and thoracic motion will be performed and a pill of placebo containing 021 g glucose will be administered patients will be instructed to take a pill of placebo before breakfast lunch and dinner during the 4-week intervention period
Aim To prove the efficacy of a noninstrumental biofeedback technique transmitted by a standard training program for the treatment of abdominal distension in different centers
Selection criteria Episodes of visible abdominal distension Intervention Patients will be randomized into biofeedback and placebo groups Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period
Biofeedback Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment Patients will be instructed to perform the same exercises before and after breakfast lunch and dinner during the 4-week intervention period
Placebo Sham measurements of abdominal and thoracic motion will be performed and a pill of placebo containing 021 g glucose will be administered patients will be instructed to take a pill of placebo before breakfast lunch and dinner during the 4-week intervention period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None