Hypnosis for Children Undergoing Anorectal Manometry

Constipation Clinical Trial

Official title:

Using Medical Hypnotherapy in Children With Defecation Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04471857
• Other study ID #: IRB15-00864
• Status: Terminated
• Phase: N/A
• Start date: January 9, 2017
• Est. completion date: March 4, 2020

Study information

• Verified date: July 2020
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Behavioral:
• Hypnosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Periprocedural
Secondary	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).	Right after anorectal manometry (same day)
Secondary	Parent-reported levels of distress	The parent accompanying the child will be asked to rate the amount of distress of the child (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). Parents of children who received hypnosis are asked if they believed that it helped the child to relax on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).	Right after anorectal manometry (same day)
Secondary	Difficulty of procedure	The motility nurse will report if all parts of the procedure could be performed properly and rates the degree of difficulty of the procedure on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).	Right after anorectal manometry (same day)
Secondary	Difficulty of hypnosis	The hypnotherapist rates the degree of difficulty of the hypnosis on a similar 5-point Likert scale ranging from 0 (not at all) to 4 (very much).	Right after anorectal manometry (same day)
Secondary	Manometry outcomes	Procedural outcomes of the children undergoing anorectal manometry will be recorded and compared between groups. This includes: resting pressure, squeeze pressure, squeeze duration, push test, duration of procedure.	Periprocedural