Hypnosis for Children Undergoing Anorectal Manometry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2020-03-04

Brief Summary

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Partially blinded randomized controlled trial investigating the effect of a brief session of hypnosis prior to anorectal manometry in children

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Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

A blinded observer assessed child distress during anorectal manometry

Study Groups

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Hypnosis

A brief session of hypnosis just before child starts with anorectal manometry

Group Type EXPERIMENTAL

Hypnosis

Intervention Type BEHAVIORAL

Control

No hypnosis session, standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hypnosis

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No