NCT00852878

Brief Summary

The purpose of this study is to determine if two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

June 23, 2015

Status Verified

December 1, 2010

Enrollment Period

10 months

First QC Date

February 26, 2009

Last Update Submit

June 19, 2015

Conditions

Recurrent Abdominal Pain

Keywords

Recurrent Abdominal PainBiofeedbackHeart Rate Variability

Outcome Measures

Primary Outcomes (1)

  • The measurable primary outcome will use equivalency testing on changes in pain diary ratings, using the average weekly pain intensity and frequency as recorded in the pain dairy

    3 Months

Secondary Outcomes (1)

  • A measurable secondary outcome will be changes in heart rate variability

    3 Months

Study Arms (2)

Biofeedback

ACTIVE COMPARATOR

heart rate variability biofeedback

Behavioral: Biofeedback

Behavioral

ACTIVE COMPARATOR

Behavioral intervention will provide parent and child with a variety of pain management techniques such as relaxation, distraction, contingency management, and coping statements

Behavioral: Behavioral Protocol

Interventions

BiofeedbackBEHAVIORAL

Biofeedback will teach resonant frequency breathing for 6-8 sessions

Also known as: resonant frequency breathing
Biofeedback
Behavioral ProtocolBEHAVIORAL

Behavioral protocol will teach a variety of pain management techniques such as relaxation, distraction, and coping statements over 6-8 sessions

Also known as: relaxation, distraction, and coping statements
Behavioral

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • who speak English
  • diagnosis with Recurrent abdominal pain

You may not qualify if:

  • lactose intolerance, urinary tract infections, or recent head trauma;
  • the use of prescribed or over he counter medications, which may interfere with the biofeedback data;
  • currently receiving other treatment for recurrent abdominal pain;
  • the receipt of a recent and related surgical procedure;
  • children who met criteria for depression or anxiety disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Vandever Medical Offices

San Diego, California, 92120, United States

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Warren L Shapiro, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2009

First Posted

February 27, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2010

Last Updated

June 23, 2015

Record last verified: 2010-12

Locations

US(1)