Hypnosis for Children Undergoing Anorectal Manometry

NCT04471857 | Terminated

• 1 other identifier: IRB15-00864
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Constipation

Keywords

hypnosis; anorectal manometry; child

Outcome Measures

Primary Outcomes (1)

• 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.

  Periprocedural

Secondary Outcomes (6)

• 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)

Study Arms (2)

Hypnosis

EXPERIMENTAL

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

Behavioral: Hypnosis

Control

NO INTERVENTION

No hypnosis session, standard care

Interventions

Hypnosis BEHAVIORAL

Hypnosis

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

MeSH Terms

Conditions

Constipation

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded observer assessed child distress during anorectal manometry
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 15, 2020
• Study Start: January 9, 2017
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share