Using Medical Hypnotherapy in Children With Defecation Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 34
- Primary Endpoint
- The primary outcome of this study will be the assessment of distress as measured by the non-blinded observer.
Study Overview
Brief Summary
Partially blinded randomized controlled trial investigating the effect of a brief session of hypnosis prior to anorectal manometry in children
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
A blinded observer assessed child distress during anorectal manometry
Eligibility Criteria
- Ages
- 4 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children aged 4-18 who are scheduled to undergo anorectal manometry testinf.
- •ASA classification I to II.
- •Both parents and children have sufficient English language proficiency.
- •Both parents and children are willing to fill out the questionnaires involved in this study.
Exclusion Criteria
- •ASA classification III, IV (children with a chronic or severe disease).
- •Children with a metabolic, endocrine or neuromuscular disorder or mental illness.
- •Children with anorectal malformations or previous anorectal surgery.
- •Children with developmental delay
- •Children with diagnosed emotional or behavioral disorders
Outcomes
Primary Outcomes
The primary outcome of this study will be the assessment of distress as measured by the non-blinded observer.
Time Frame: Periprocedural
The non-blinded observer will use the Observation Scale of Behavioral Distress (OSBD) to assess the periprocedural distress of the child. The OSBD records the presence or absence of thirteen operationally-defined behaviors, which indicate discomfort (e.g. cry, verbal resistance, information seeking) at 15-second intervals throughout the procedure. The behaviors are given a score ranging from 1 to 4 according to the severity of distress that is expressed by that behavior. The recorded score during a 15-second interval can range from zero (no distress) to 33.5 (extreme distress). The total scores will be summed up and then divided by the number of 15-second intervals to obtain a mean distress score.
Secondary Outcomes
- Periprocedural distress as measured by the blinded observer(Periprocedural)
- Child-reported levels of distress(Right after anorectal manometry (same day))
- Parent-reported levels of distress(Right after anorectal manometry (same day))
- Difficulty of procedure(Right after anorectal manometry (same day))
- Difficulty of hypnosis(Right after anorectal manometry (same day))
- Manometry outcomes(Periprocedural)
Investigators
Frederick Woodley
PhD
Nationwide Children's Hospital