AnxietyNCT00841022
Information and Anaesthesia in Paediatrics
A study testing Information with comics in people with Anxiety, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy. Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Information with comics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Apr 2013
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female children between 6 to 16 years and 11 month old.
- Children scheduled to have a craniotomy or orthopaedic surgery (multi-level surgery, spinal decompression, osteosarcoma resection, column surgery , fibroid curettage, Nuss bar procedure, hip varus surgery) or visceral and urologic surgery (intestinal continuity restoration, hypospadias surgery, bladder malformation, sarcoma).
- Children with a high, normal or light level of verbal comprehension (normal academic level or less than two repeating).
- Children coming with their parents.
Who cannot join
- Previous surgery.
- Unwillingness to participate (parents or child)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial
This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.
Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention.
Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.
- Conditions
- Anxiety
- Being tested
- Information with comics
- Keywords
- anxiety, anaesthesia, child, RCT, Elective surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information with comicsOther
Information of children with comic leaflet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Information of children with comic leaflet Receives: Other: Information with comics |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anxiety scale (STAIC-S)
Measured: before preanaesthesia consultation and after preanaesthesia consultation
Secondary outcomes (2)
Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension)
Measured: before preanaesthesia consultation
Level of anxiety scale (STAIC-T)
Measured: Before preanaesthesia consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edmundo PEREIRA DE SOUZA NETO, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841022
- Sponsor's protocol ID
- 2008.518
- Status last verified
- Oct 2013
- First submitted
- 10 Feb 2009
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.
PubMed 27317708
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Comics on Anaesthesia's Anxiety in Paediatrics: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00841022
- Acronym / sponsor ID
- 2008.518
- Conditions
- Anxiety
- Keywords
- anxiety, anaesthesia, child, RCT, Elective surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Feb 2009 (estimated)
- 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.
This study aims to investigate whether detailed and illustrated information (comics) about anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.
Children scheduled for craniotomy are randomized to groups receiving a comic leaflet explaining the course of anaesthesia before preanaesthesia visit or no intervention.
Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Information with comicsInformation of children with comic leaflet |
| 2 | No intervention | – |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female children between 6 to 16 years and 11 month old.
- Children scheduled to have a craniotomy or orthopaedic surgery (multi-level surgery, spinal decompression, osteosarcoma resection, column surgery , fibroid curettage, Nuss bar procedure, hip varus surgery) or visceral and urologic surgery (intestinal continuity restoration, hypospadias surgery, bladder malformation, sarcoma).
- Children with a high, normal or light level of verbal comprehension (normal academic level or less than two repeating).
- Children coming with their parents.
Key exclusion criteria (2 listed)
- Previous surgery.
- Unwillingness to participate (parents or child)
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 |
|---|---|---|
| Information with comicsInformation of children with comic leaflet | Other | 1 |
Primary outcome
Level of anxiety scale (STAIC-S)
Time frame: before preanaesthesia consultation and after preanaesthesia consultation
2 secondary outcomes
Level of verbal comprehension : WISC 4 (similitude, vocabulary and comprehension)
Time frame: before preanaesthesia consultation
Level of anxiety scale (STAIC-T)
Time frame: Before preanaesthesia consultation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 27317708Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.
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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.
Edmundo PEREIRA DE SOUZA NETO, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information with comics in people with Anxiety, run by Hospices Civils de Lyon 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 28 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of anxiety scale (STAIC-S) (time frame: before preanaesthesia consultation and after preanaesthesia consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00841022, which also lists 1 linked publication.
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 28 May 2019.