PainICODNCT05206344
The Benefit of the Intervention of Clowns in Pediatric Oncology in the Accompaniment of Painful Acts
A study testing clowns in people with Pain, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The diagnosis and treatment of childhood cancer involves frequent and repeated painful acts. The pediatric oncology-hematology service of Nancy's hospital innovates thanks to the involvement of clowns in the hospital. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Pain
- What is being tested?
- clowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2022to 8 Oct 2024
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child virgin with experience for targeted acts during the 1st painful act or child undergoing follow-up provided that he is virgin with experience of the presence of clowns during these acts.
- Child with cancer
- Child requiring a painful act among the following 3 acts: lumbar puncture, myelogram, needle placement in an implantable chamber
- Parental authority holder (s) who have received full information on the organization of the research and who have given their written consent for the participation of their child
- Personal adhesion of the child with a view to his participation
- Presence of at least one of the two parents during act 1
- Availability of the duo of clowns for the realization of act n ° 1 if the group assigned is the group Clowns-Sans Clowns
Who cannot join
- Parents / child's refusal of clowns to intervene
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy, 54035
Valérie Gaüzes
Valérie Gaüzes
About this study
Official title: Study on the Benefit of the Intervention of Clowns in Pediatric Oncology in the Accompaniment of Painful Acts
The diagnosis and treatment of childhood cancer involves frequent and repeated painful acts. The pediatric oncology-hematology service of Nancy's hospital innovates thanks to the involvement of clowns in the hospital. The effects of the clown's intervention corroborate the results of studies which demonstrate that when painful complaints are increased by an empathetic attitude, they are reduced by half when the child is distracted.
The main objective is to assess the impact of the presence or absence of clowns during the performance of a painful act, on pain, in children who have benefited from this act. no clowns during the performance of a painful act, on anxiety, in children who have benefited from this act.
Read more
The secondary objectives are:
- Evaluate the impact of the presence or not of clowns during the performance of a painful act, on the anxiety of the parents of the child who benefited from this act.
- Measure the perception and acceptance of the healthcare team of the presence of clowns 1 time every 3 months.
- Measure the clowns' perception of their interaction with the child, the parents and the healthcare team once every 3 months.
- Evaluate the overall impact of the clown intervention during the performance of a painful act in children on the course of the act by a "neutral" person (health manager) once every 3 months.
- Conditions
- Pain
- Being tested
- clowns
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clownsOther
presence or absence of clowns during the performance of a painful act, on pain
| Study group | Role | What they receive |
|---|---|---|
| Without Clowns - Clowns (WC-C) | Other | Firstly a painful act without the presence of the clown duo, then in a second time the same painful act in the presence of the clown duo Receives: Other: clowns |
| Clowns- Without clowns (C-WC) | Other | Firstly a painful act with the presence of the clown duo, then in a seconde time, the same painful act without the presence of the clown duo Receives: Other: clowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain score of the patient Self Assessment Scale (VAS)
The scale is between 0 to 100
Measured: inclusion, up to 2 years
Secondary outcomes (9)
Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)
The scale is between 0 to 100 If the score is inferior to 24, the patient is considered relaxed If the score is superior to 24, the patient is considered anxious
Measured: inclusion, up to 2 years
Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)
The scale is between 0 to 100 If the score is inferior to 24, the patient is considered relaxed If the score is superior to 24, the patient is considered anxious
Measured: up to 8 weeks after inclusion
Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)
The score is between 21 to 77 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety
Measured: inclusion, up to 2 years
Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)
The score is between 21 to 77 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety
Measured: up to 8 weeks after inclusion
Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)
The score is between 20 to 80 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety
Measured: inclusion, up to 2 years
Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)
The score is between 20 to 80 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety
Measured: up to 8 weeks after inclusion
Score of perception and acceptance of the presence of clowns with the healthcare team Questionnaire
The questionnaire is composed by 19 questions The scale of each question is between 1 (not agree at all) to 4 (totally agree)
Measured: through completion of the study, an average of 2 years
Perception score of interactions with the child, parents and the team with clowns Questionnaire
The questionnaire is composed by 12 questions The scale of each question is between 1 (not agree at all) to 4 (totally agree)
Measured: through completion of the study, an average of 2 years
Score of evaluation of the overall impact of the presence or not of a clown Questionnaire
The observation gris is composed by 14 questions
Measured: through completion of the study, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start8 Feb 2022
- Primary completion8 Apr 2024 (estimated)
- Study completion8 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madame Valérie GAÜZES, Central Hospital, Nancy, France
- Investigators
- Pascal Chastagner, Study director, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206344
- Sponsor's protocol ID
- 2019-A03302-55
- Acronym
- ICOD
- Status last verified
- Mar 2022
- First submitted
- 15 Oct 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Benefit of the Intervention of Clowns in Pediatric Oncology in the Accompaniment of Painful Acts
- ClinicalTrials.gov ID
- NCT05206344
- Acronym / sponsor ID
- ICOD / 2019-A03302-55
- Conditions
- Pain
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 8 Apr 2024 (estimated)
- Study completion
- 8 Oct 2024 (estimated)
- First posted
- 25 Jan 2022 (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.
The diagnosis and treatment of childhood cancer involves frequent and repeated painful acts. The pediatric oncology-hematology service of Nancy's hospital innovates thanks to the involvement of clowns in the hospital. The effects of the clown's intervention corroborate the results of studies which demonstrate that when painful complaints are increased by an empathetic attitude, they are reduced by half when the child is distracted.
The main objective is to assess the impact of the presence or absence of clowns during the performance of a painful act, on pain, in children who have benefited from this act. no clowns during the performance of a painful act, on anxiety, in children who have benefited from this act.
The secondary objectives are:
- Evaluate the impact of the presence or not of clowns during the performance of a painful act, on the anxiety of the parents of the child who benefited from this act.
- Measure the perception and acceptance of the healthcare team of the presence of clowns 1 time every 3 months.
- Measure the clowns' perception of their interaction with the child, the parents and the healthcare team once every 3 months.
- Evaluate the overall impact of the clown intervention during the performance of a painful act in children on the course of the act by a "neutral" person (health manager) once every 3 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Clowns - Clowns (WC-C) | Other | Other: clownsFirstly a painful act without the presence of the clown duo, then in a second time the same painful act in the presence of the clown duo |
| Clowns- Without clowns (C-WC) | Other | Other: clownsFirstly a painful act with the presence of the clown duo, then in a seconde time, the same painful act without the presence of the clown duo |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child virgin with experience for targeted acts during the 1st painful act or child undergoing follow-up provided that he is virgin with experience of the presence of clowns during these acts.
- Child with cancer
- Child requiring a painful act among the following 3 acts: lumbar puncture, myelogram, needle placement in an implantable chamber
- Parental authority holder (s) who have received full information on the organization of the research and who have given their written consent for the participation of their child
- Personal adhesion of the child with a view to his participation
Key exclusion criteria (1 listed)
- Parents / child's refusal of clowns to intervene
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 |
|---|---|---|
| clownspresence or absence of clowns during the performance of a painful act, on pain | Other | Clowns- Without clowns (C-WC), Without Clowns - Clowns (WC-C) |
Primary outcome
Change of Pain score of the patient Self Assessment Scale (VAS)
Time frame: inclusion, up to 2 years
The scale is between 0 to 100
9 secondary outcomes
Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)
Time frame: inclusion, up to 2 years
Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS)
Time frame: up to 8 weeks after inclusion
Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)
Time frame: inclusion, up to 2 years
Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B)
Time frame: up to 8 weeks after inclusion
Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)
Time frame: inclusion, up to 2 years
Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A)
Time frame: up to 8 weeks after inclusion
Score of perception and acceptance of the presence of clowns with the healthcare team Questionnaire
Time frame: through completion of the study, an average of 2 years
Perception score of interactions with the child, parents and the team with clowns Questionnaire
Time frame: through completion of the study, an average of 2 years
Score of evaluation of the overall impact of the presence or not of a clown Questionnaire
Time frame: through completion of the study, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Pascal Chastagner study director
CHRU de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clowns in people with Pain, run by Central Hospital, Nancy, France at 1 site in France.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valérie GAUZES (0383154066, v.gauzes@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain score of the patient Self Assessment Scale (VAS) (time frame: inclusion, up to 2 years). 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 14 Mar 2022.