ConstipationNCT04471857
Hypnosis for Children Undergoing Anorectal Manometry
A study testing Hypnosis in people with Constipation, run by Nationwide Children's Hospital.
Trial summary
Partially blinded randomized controlled trial investigating the effect of a brief session of hypnosis prior to anorectal manometry in children Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Constipation
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to 4 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Using Medical Hypnotherapy in Children With Defecation Disorders
Partially blinded randomized controlled trial investigating the effect of a brief session of hypnosis prior to anorectal manometry in children
- Conditions
- Constipation
- Being tested
- Hypnosis
- Keywords
- hypnosis, anorectal manometry, child
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | A brief session of hypnosis just before child starts with anorectal manometry Receives: Behavioral: Hypnosis |
| Control | No intervention | No hypnosis session, standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural
Secondary outcomes (6)
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.
Measured: 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).
Measured: Right after anorectal manometry (same day)
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).
Measured: Right after anorectal manometry (same day)
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).
Measured: Right after anorectal manometry (same day)
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).
Measured: Right after anorectal manometry (same day)
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.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start9 Jan 2017
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Why it stopped: Due to COVID-19 recruitement stopped since intended sample size was an estimation and not based on power calculation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Frederick Woodley, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471857
- Sponsor's protocol ID
- IRB15-00864
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Medical Hypnotherapy in Children With Defecation Disorders
- ClinicalTrials.gov ID
- NCT04471857
- Acronym / sponsor ID
- IRB15-00864
- Conditions
- Constipation
- Keywords
- hypnosis, anorectal manometry, child
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 recruitement stopped since intended sample size was an estimation and not based on power calculation
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Partially blinded randomized controlled trial investigating the effect of a brief session of hypnosis prior to anorectal manometry in children
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Behavioral: HypnosisA brief session of hypnosis just before child starts with anorectal manometry |
| Control | No intervention | –No hypnosis session, standard care |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosis | Behavioural | Hypnosis |
Primary outcome
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.
6 secondary outcomes
Periprocedural distress as measured by the blinded observer
Time frame: Periprocedural
Child-reported levels of distress
Time frame: Right after anorectal manometry (same day)
Parent-reported levels of distress
Time frame: Right after anorectal manometry (same day)
Difficulty of procedure
Time frame: Right after anorectal manometry (same day)
Difficulty of hypnosis
Time frame: Right after anorectal manometry (same day)
Manometry outcomes
Time frame: Periprocedural
Results and safety
The study was stopped early (reason given: Due to COVID-19 recruitement stopped since intended sample size was an estimation and not based on power calculation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Constipation, run by Nationwide Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID-19 recruitement stopped since intended sample size was an estimation and not based on power calculation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of this study will be the assessment of distress as measured by the non-blinded observer. (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020; AzTrials last refreshed its copy on 29 Oct 2026.