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Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children (ANXIDOU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04206956
Recruitment Status : Recruiting
First Posted : December 20, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de Saint-Brieuc

Brief 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.

Condition or disease
Ambulatory Surgery Children, Only Inguinal Hernia Umbilical Hernia Urologic 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)

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Study Type : Observational
Estimated Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  1. 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)


  2. 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"

  3. 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).

  4. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children undergoing scheduled abdominal or urologic ambulatory surgery
Criteria

Inclusion Criteria:

  • child from 3 to 18 years old
  • undergoing scheduled urology or abdominal ambulatory surgery
  • child and parents speaking French
  • affiliation to national health insurance

Exclusion Criteria:

  • emergency surgery
  • lack of parents consent
  • no parental support on surgery day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206956


Contacts
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Contact: Gwenaelle Le Garff, Dr +33296017277 gwenaelle.legarff@armorsante.bzh
Contact: Catherine Bellot +33296017340 catherine.bellot@armorsante.bzh

Locations
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France
Centre Hospitalier de Saint-Brieuc Recruiting
Saint-Brieuc, France, 22027
Contact: Gwenaëlle Le Garff    +33296017277    gwenaelle.legarff@armorsante.bzh   
Contact: Catherine Bellot    +33296017340    catherine.bellot@armorsante.bzh   
Principal Investigator: Claire Barbarot, Dr         
Sponsors and Collaborators
Centre Hospitalier de Saint-Brieuc
Investigators
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Principal Investigator: Claire Barbarot, Dr Centre Hopsitalier Saint-Brieuc
Publications:

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Responsible Party: Centre Hospitalier de Saint-Brieuc
ClinicalTrials.gov Identifier: NCT04206956    
Other Study ID Numbers: CHSB-2019-05-P2-ANXIDOU
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier de Saint-Brieuc:
pediatric department
children
chronic postsurgical pain
perioperative anxiety
Additional relevant MeSH terms:
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Hernia, Umbilical
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Infant, Newborn, Diseases
Hernia, Ventral