Ambulatory SurgeryANXIDOUNCT04206956
Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children
An observational study of Ambulatory Surgery and Children, Only, run by Centre Hospitalier de Saint-Brieuc at 1 site in France.
Trial summary
Prospective, monocentric, observationnal study. The primary objective of this study is to identify if presurgical child or/and parental anxiety is predictive of chronic postsurgical pain in abdominal or urologic ambulatory surgery. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Ambulatory Surgery, Children, Only, Inguinal Hernia
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2019to Sep 2020
- Phase
- Observational
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children undergoing scheduled abdominal or urologic ambulatory surgery
Who may be able to join
- child from 3 to 18 years old
- undergoing scheduled urology or abdominal ambulatory surgery
- child and parents speaking French
- affiliation to national health insurance
Who cannot join
- emergency surgery
- lack of parents consent
- no parental support on surgery day
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc, 22027
Gwenaëlle Le Garff, +33296017277, gwenaelle.legarff@armorsante.bzh
Catherine Bellot, +33296017340, catherine.bellot@armorsante.bzh
About this study
Prospective, monocentric, observationnal study. The primary objective of this study is to identify if presurgical child or/and parental anxiety is predictive of chronic postsurgical pain in abdominal or urologic ambulatory surgery.
Read the detailed description
The post surgical pain guidelines recommend to identify predictive factors, especially for vulnerable subjects.
For children, there is few data about predictive factors of postoperative pain after ambulatory surgery.
The objective of this study is to collect preoperative data (preoperative children's anxiety and parental anxiety) and postoperative data (postoperative pain measure: the day of surgery and 3 months after surgery) for children undergoing abdominal ou urologic ambulatory surgery, and to determine if there is a relationship between these data (Odds Ratio)
- Keywords
- pediatric department, children, chronic postsurgical pain, perioperative anxiety
- Medical subject headings
- Hernia, Inguinal, Hernia, Umbilical, Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's preoperative anxiety
- For children younger than 12 : mYPAS (the Modified Yale Preoperative Anxiety Scale).
If the score is less than 24 : quiet child. If the score is greater than 24 : anxious child
- For children older than 12 : anxiety visual analog scale (VAS) From 0 (better) to 10 (worse)
Measured: Preoperative : day of surgery
Parents' preoperative anxiety
anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means "anxious"
Measured: Preoperative: day of surgery
children's pain
- for children younger than 6: Evendol scale. From 0 (better) to 15 (worse)
- for children older than 6: anxiety visual analog scale (VAS) From 0 (better) to 10 (worse).
Measured: postoperative: day of surgery
Chronic postsurgical pain in children
For all children, score PPMP (Postoperative Pain Measure for Parents) From 0 (better) to 10 (worse)
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start14 Oct 2019
- Primary completionJun 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ambulatory SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Brieuc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Barbarot, Dr, Principal investigator, Centre Hopsitalier Saint-Brieuc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206956
- Sponsor's protocol ID
- CHSB-2019-05-P2-ANXIDOU
- Acronym
- ANXIDOU
- Status last verified
- Jan 2020
- First submitted
- 9 Dec 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rabbitts JA, Fisher E, Rosenbloom BN, Palermo TM. Prevalence and Predictors of Chronic Postsurgical Pain in Children: A Systematic Review and Meta-Analysis. J Pain. 2017 Jun;18(6):605-614. doi: 10.1016/j.jpain.2017.03.007. Epub 2017 Mar 29.
PubMed 28363861Batoz H, Semjen F, Bordes-Demolis M, Benard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.
PubMed 28077537Noel M, Rosenbloom B, Pavlova M, Campbell F, Isaac L, Page MG, Stinson J, Katz J. Remembering the pain of surgery 1 year later: a longitudinal examination of anxiety in children's pain memory development. Pain. 2019 Aug;160(8):1729-1739. doi: 10.1097/j.pain.0000000000001582.
PubMed 31335643Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.
PubMed 23865442Page MG, Campbell F, Isaac L, Stinson J, Katz J. Parental risk factors for the development of pediatric acute and chronic postsurgical pain: a longitudinal study. J Pain Res. 2013 Sep 30;6:727-41. doi: 10.2147/JPR.S51055. eCollection 2013.
PubMed 24109194Rabbitts JA, Zhou C, Groenewald CB, Durkin L, Palermo TM. Trajectories of postsurgical pain in children: risk factors and impact of late pain recovery on long-term health outcomes after major surgery. Pain. 2015 Nov;156(11):2383-2389. doi: 10.1097/j.pain.0000000000000281.
PubMed 26381701Birnie KA, Chorney J, El-Hawary R; PORSCHE Study Group. Child and parent pain catastrophizing and pain from presurgery to 6 weeks postsurgery: examination of cross-sectional and longitudinal actor-partner effects. Pain. 2017 Oct;158(10):1886-1892. doi: 10.1097/j.pain.0000000000000976.
PubMed 28598902Kristensen AD, Ahlburg P, Lauridsen MC, Jensen TS, Nikolajsen L. Chronic pain after inguinal hernia repair in children. Br J Anaesth. 2012 Oct;109(4):603-8. doi: 10.1093/bja/aes250. Epub 2012 Jul 24.
PubMed 22831892Mossetti V, Boretsky K, Astuto M, Locatelli BG, Zurakowski D, Lio R, Nicoletti R, Sonzogni V, Maffioletti M, Vicchio N, Ivani G. Persistent pain following common outpatient surgeries in children: A multicenter study in Italy. Paediatr Anaesth. 2018 Mar;28(3):231-236. doi: 10.1111/pan.13321. Epub 2018 Jan 20.
PubMed 29352738Pinto PR, McIntyre T, Nogueira-Silva C, Almeida A, Araujo-Soares V. Risk factors for persistent postsurgical pain in women undergoing hysterectomy due to benign causes: a prospective predictive study. J Pain. 2012 Nov;13(11):1045-57. doi: 10.1016/j.jpain.2012.07.014. Epub 2012 Oct 12.
PubMed 23063345
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children
- ClinicalTrials.gov ID
- NCT04206956
- Acronym / sponsor ID
- ANXIDOU / CHSB-2019-05-P2-ANXIDOU
- Keywords
- pediatric department, children, chronic postsurgical pain, perioperative anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-BrieucUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 20 Dec 2019 (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.
Prospective, monocentric, observationnal study. The primary objective of this study is to identify if presurgical child or/and parental anxiety is predictive of chronic postsurgical pain in abdominal or urologic ambulatory surgery.
Detailed description
The post surgical pain guidelines recommend to identify predictive factors, especially for vulnerable subjects.
For children, there is few data about predictive factors of postoperative pain after ambulatory surgery.
The objective of this study is to collect preoperative data (preoperative children's anxiety and parental anxiety) and postoperative data (postoperative pain measure: the day of surgery and 3 months after surgery) for children undergoing abdominal ou urologic ambulatory surgery, and to determine if there is a relationship between these data (Odds Ratio)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing scheduled abdominal or urologic ambulatory surgery
Key inclusion criteria (4 listed)
- child from 3 to 18 years old
- undergoing scheduled urology or abdominal ambulatory surgery
- child and parents speaking French
- affiliation to national health insurance
Key exclusion criteria (3 listed)
- emergency surgery
- lack of parents consent
- no parental support on surgery day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Children's preoperative anxiety
Time frame: Preoperative : day of surgery
- For children younger than 12 : mYPAS (the Modified Yale Preoperative Anxiety Scale). If the score is less than 24 : quiet child. If the score is greater than 24 : anxious child - For children older than 12 : anxiety visual analog scale (VAS) From 0 (better) to 10 (worse)
Parents' preoperative anxiety
Time frame: Preoperative: day of surgery
anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means "anxious"
children's pain
Time frame: postoperative: day of surgery
* for children younger than 6: Evendol scale. From 0 (better) to 15 (worse) * for children older than 6: anxiety visual analog scale (VAS) From 0 (better) to 10 (worse).
Chronic postsurgical pain in children
Time frame: 3 months after surgery
For all children, score PPMP (Postoperative Pain Measure for Parents) From 0 (better) to 10 (worse)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 28363861Rabbitts JA, Fisher E, Rosenbloom BN, Palermo TM. Prevalence and Predictors of Chronic Postsurgical Pain in Children: A Systematic Review and Meta-Analysis. J Pain. 2017 Jun;18(6):605-614. doi: 10.1016/j.jpain.2017.03.007. Epub 2017 Mar 29.
- Background: PubMed 28077537Batoz H, Semjen F, Bordes-Demolis M, Benard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.
- Background: PubMed 31335643Noel M, Rosenbloom B, Pavlova M, Campbell F, Isaac L, Page MG, Stinson J, Katz J. Remembering the pain of surgery 1 year later: a longitudinal examination of anxiety in children's pain memory development. Pain. 2019 Aug;160(8):1729-1739. doi: 10.1097/j.pain.0000000000001582.
- Background: PubMed 23865442Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.
- Background: PubMed 24109194Page MG, Campbell F, Isaac L, Stinson J, Katz J. Parental risk factors for the development of pediatric acute and chronic postsurgical pain: a longitudinal study. J Pain Res. 2013 Sep 30;6:727-41. doi: 10.2147/JPR.S51055. eCollection 2013.
- Background: PubMed 26381701Rabbitts JA, Zhou C, Groenewald CB, Durkin L, Palermo TM. Trajectories of postsurgical pain in children: risk factors and impact of late pain recovery on long-term health outcomes after major surgery. Pain. 2015 Nov;156(11):2383-2389. doi: 10.1097/j.pain.0000000000000281.
- Background: PubMed 28598902Birnie KA, Chorney J, El-Hawary R; PORSCHE Study Group. Child and parent pain catastrophizing and pain from presurgery to 6 weeks postsurgery: examination of cross-sectional and longitudinal actor-partner effects. Pain. 2017 Oct;158(10):1886-1892. doi: 10.1097/j.pain.0000000000000976.
- Background: PubMed 22831892Kristensen AD, Ahlburg P, Lauridsen MC, Jensen TS, Nikolajsen L. Chronic pain after inguinal hernia repair in children. Br J Anaesth. 2012 Oct;109(4):603-8. doi: 10.1093/bja/aes250. Epub 2012 Jul 24.
- Background: PubMed 29352738Mossetti V, Boretsky K, Astuto M, Locatelli BG, Zurakowski D, Lio R, Nicoletti R, Sonzogni V, Maffioletti M, Vicchio N, Ivani G. Persistent pain following common outpatient surgeries in children: A multicenter study in Italy. Paediatr Anaesth. 2018 Mar;28(3):231-236. doi: 10.1111/pan.13321. Epub 2018 Jan 20.
- Background: PubMed 23063345Pinto PR, McIntyre T, Nogueira-Silva C, Almeida A, Araujo-Soares V. Risk factors for persistent postsurgical pain in women undergoing hysterectomy due to benign causes: a prospective predictive study. J Pain. 2012 Nov;13(11):1045-57. doi: 10.1016/j.jpain.2012.07.014. Epub 2012 Oct 12.
Related trials for Ambulatory Surgery
Not yet recruiting
Feasibility Study of a Conversational Chatbot for Outpatient Postoperative Follow-up in Otorhinolaryngology (ENT): Acceptability, Patterns of Use, and Patient Experience.
Surgery Ambulatory, ENT Surgery
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Active, not recruitingObservational study
Quality ImprOvement stUdy ouTpatient Surgery rapID movE
Postoperative Recovery
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.
Claire Barbarot, Dr principal investigator
Centre Hopsitalier Saint-Brieuc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ambulatory Surgery and Children, Only, run by Centre Hospitalier de Saint-Brieuc 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 3 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 13 Jan 2020. 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 Gwenaelle Le Garff, Dr (+33296017277, gwenaelle.legarff@armorsante.bzh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's preoperative anxiety (time frame: Preoperative : day of surgery). The study lists 4 primary outcomes in all. 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 NCT04206956, which also lists 10 linked publications.
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 13 Jan 2020.