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Behavioral therapy for treatment of childhood constipation: a randomized controlled trial.

Behavioral therapy for treatment of childhood constipation: a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23675
Enrollment
129
Registered
2007-01-15
Start date
2002-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional constipation.

Interventions

Intervention period for both conventional treatment (CT) and behavioral therapy (BT) consisted of 12 visits to the outpatient clinic during 22 weeks. Conventional Treatment: CT was conducted by ped
16:312-316). Basic assumption of this BT is that fearful and phobic reactions related to defecation and fecal incontinence can be reduced and that adequate defecation straining and toileting behavior

Sponsors

This research was funded by grants from the MLDS (SWO 02-16).
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 4-18 years with functional constipation as defined by the classic Iowa criteria. Patients had to meet at least two of four criteria of pediatric constipation: defecation frequency less than three times per week, fecal incontinence frequency two or more times per week, passage of large amounts of stool at least once every 7-30 days (large enough to clog the toilet), or a palpable abdominal or rectal fecal mass.

Exclusion criteria

Exclusion criteria: Children were excluded from the study if they had already been treated at our gastrointestinal outpatient clinic or had received a comprehensive behavioral treatment in the previous 12 months. In addition, children using drugs influencing gastrointestinal function other than laxative and children with organic causes for defecation disorders such as Hirschsprung's disease, spina bifida occulta, hypothyroidism or other metabolic or renal abnormalities were excluded.

Design outcomes

Primary

MeasureTime frame
Defecation frequency (DF) per week, fecal incontinence frequency (FIF) per week, successful treatment and relapse. Success was defined as DF >= 3 times/week and FIF <= 1 times/two weeks irrespectively of laxative use. A relapse was defined as being unsuccessful at follow-up, while being successful at posttreatment. Assessments were done posttreatment and at 6-months follow-up during a clinical visit or by telephone.

Secondary

MeasureTime frame
Secondary outcome measures were: stool-withholding behavior, mean CBCL T-scores and the proportion of children with behavioral scores in the clinical range (T-score>63). Assessments were done posttreatment and at 6-months follow-up during a clinical visit or by telephone.

Contacts

Public ContactMarc A. Benninga

Kinderarts MDL, AMC, H7-248 P.O. Box 22660

m.a.benninga@amc.nl+31 (0)20 5663053 / +31 (0)20 5666297

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)