Hypnosis for Children Undergoing Anorectal Manometry

Nationwide Children's Hospital34 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Constipation

Interventions

HypnosisBEHAVIORAL

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

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.

Time frame: Periprocedural

Secondary Outcomes

Periprocedural distress as measured by the blinded observer

The blinded observer rates the child's distress on a 4-point Likert scale ranging from 0 (not anxious at all) to 3 (extremely anxious). Ratings are based on facial features, crying, and physical movements. The blinded observer reports the highest (i.e. peak), most common (i.e. typical),and the lowest level of distress. We will compare the highest and most common levels of distress between groups, as we believed these levels of distress are most clinically relevant.

Time frame: Periprocedural

Child-reported levels of distress

The child will be asked to rate the amount of distress experienced (unpleasantness, nervousness, and anxiety) during the manometry on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). They are also asked to rate the pain of the procedure on an analogous scale of 0 (no pain) to 10 (extremely painful). Children who received hypnosis are asked if they believed that it helped them to relax on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).

Time frame: Right after anorectal manometry (same day)

Parent-reported levels of distress

Data from ClinicalTrials.gov

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