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Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively (PHEDOPO) (PHEDOPO)

Primary Purpose

Pain, Postoperative, Anxiety, Dental

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pain, Postoperative focused on measuring Pain, Oral surgery, Postoperative, Gender, Eye color, Blood group, Hair color

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient, male or female, eligible for dental extraction under local anesthesia,

    • either a tooth on the arch,
    • either wisdom tooth(s) (2 homolateral wisdom teeth (maxilla + mandibular) or a mandibular wisdom tooth).
  • Fluent in speaking and reading French.
  • Able to give informed consent to research.
  • Affiliation to a Social Security scheme.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Contraindication to paracetamol, NSAIDs, tramadol, or anesthetic agents local.
  • Patient uncooperative, unlikely or unable to comply with all procedures of the protocol.
  • Chronic use of opiates, in a therapeutic or illicit context.
  • Chronic depression on long-term antidepressants.
  • Stomatological pathology that may interfere with the conduct of the intervention or modify the results: insufficient mouth opening, pathologies of the temporal mandibular joints ...
  • Active medical pathology, or any medical condition judged by the investigator to be incompatible with the study.
  • Patient under guardianship, curatorship or safeguard of justice.
  • Refusal to participate.

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open-label cohort, with short follow-up

Arm Description

This is a collection of data from postoperative questionnaires and simple, non-invasive clinical observations. The oral surgery acts in question are performed in daily practice without any change in patient management. The intraoperative data collected come from routine care. Postoperative data (pain and analgesic intake) are collected by self-questionnaires and no visit on purpose is required.

Outcomes

Primary Outcome Measures

Postoperative pain Day 1
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 1
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 2
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 2
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 3
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 3
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 4
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 4
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 5
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Postoperative pain Day 5
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"

Secondary Outcome Measures

Explanatory variable 1: Pain Sensitive Questionnaire
The Pain Sensitivity Questionnaire (PSQ) is a self-administered questionnaire comprising 17 items, each rated from 0 to 10. items n° 3-6-7-10-11-12-14 evoke moderately painful situations (and their sum makes it possible to calculate a "minor" PSQ score), and items n° 1-2-4-8- 15-16-17 evoke clearly painful situations (and their sum makes it possible to calculate a "moderate" PSQ score). The sum of these two scores is the "total" PSQ score. As each response to each item ranges from 0 to 10, the minimum value for all scores is 0, and the maximal ones for the minor, the moderate and the total PSQ scores are respectively 7, 7 and 14. The higher the scores, the higher the sensitivity to pain.
Explanatory variable 2: Corah's Dental Anxiety Scale (CDAS)
Corah's Dental Anxiety Scale is based on 4 main questions and calculates a score from 5 to 20 (0-8: no anxiety; 9-12: moderate anxiety; 13-14: high anxiety; 15-20: severe anxiety)
Explanatory variable 3: Pain Catastrophizing Scale (PCS)
Pain Catastrophizing Scale is based on 13 questions that cover 3 representative domains of dramatization: exaggeration of the pain felt (magnification), the tendency to constantly meditate on the pain (rumination) and the feeling of abandonment or lack of associated support (helplessness). As each response to each of the 13 responses items ranges from 0 to 4, the minimum value for the PCS score is 0, and the maximal is 52. The higher the score, the higher the level of pain catastrophizing.
Explanatory variable 4: Gender
Gender will be determined between male or female subject
Explanatory variable 5: Eye color
The color of the iris will be determined by the scale of Martine and Schultz: Light tones: 1-2: Blue 3: Blue gray 4: Gray 5: Blue-gray with yellow/brown spots 6: Grey-green with yellow/brown spots 7: Green 8: Green with yellow/brown spots 9-10-11: Light brown or hazelnut brown Dark tones: 12-13: Brown 14-15: Dark brown to black
Explanatory variable 6: Hair color
Hair color will be determined by color: Black Brown Blond Red
Explanatory variable 7: Blood group
The blood group will be determined by the groups: O HAS B AB as well as Rhesus + or -

Full Information

First Posted
April 5, 2022
Last Updated
July 18, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT05405088
Brief Title
Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively (PHEDOPO)
Acronym
PHEDOPO
Official Title
Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This project aims to study various predictive factors of postoperative pain after oral surgery among different parameters accessible preoperatively, in order to build a predictive model. It also aims to validate the external consistency of the Pain Sensitivity Questionnaire in an odontological context.
Detailed Description
This project aims to study various predictive factors of postoperative pain after oral surgery among different phenotypic parameters accessible to preoperative interrogation (anxiety about dental care, personal perception of pain sensitivity, gender, eye color, hair color, blood group) in order to build a predictive model. It also aims to validate the external consistency of the Pain Sensitivity Questionnaire (PSQ) in an odontological context, by studying the relationship between the personal perception of pain sensitivity (measured by the PSQ) and anxiety about dental care (measured by the Corah Dental Anxiety Scale), as well as dramatization in the face of pain (measured by the Pain Catastrophizing Scale).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anxiety, Dental
Keywords
Pain, Oral surgery, Postoperative, Gender, Eye color, Blood group, Hair color

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a collection of data from postoperative questionnaires and simple, non-invasive clinical observations. The oral surgery acts in question are performed in daily practice without any change in patient management. The intraoperative data collected come from routine care. Postoperative data (pain and analgesic intake) are collected by self-questionnaires and no visit on purpose is required.
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-label cohort, with short follow-up
Arm Type
Other
Arm Description
This is a collection of data from postoperative questionnaires and simple, non-invasive clinical observations. The oral surgery acts in question are performed in daily practice without any change in patient management. The intraoperative data collected come from routine care. Postoperative data (pain and analgesic intake) are collected by self-questionnaires and no visit on purpose is required.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Pain Sensitive Questionnaire (PSQ) Corah's Dental Anxiety Scale (CDAS) Pain Catastrophizing Scale (PCS) Gender Eye color Hair color Blood group
Primary Outcome Measure Information:
Title
Postoperative pain Day 1
Description
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Time Frame
Information gathering on the morning of day 1
Title
Postoperative pain Day 1
Description
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Time Frame
Information gathering on the evening of day 1
Title
Postoperative pain Day 2
Description
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Time Frame
Information gathering on the morning of day 2
Title
Postoperative pain Day 2
Description
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Time Frame
Information gathering on the evening of day 2
Title
Postoperative pain Day 3
Description
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Time Frame
Information gathering on the morning of day 3
Title
Postoperative pain Day 3
Description
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Time Frame
Information gathering on the evening of day 3
Title
Postoperative pain Day 4
Description
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Time Frame
Information gathering on the morning of day 4
Title
Postoperative pain Day 4
Description
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Time Frame
Information gathering on the evening of day 4
Title
Postoperative pain Day 5
Description
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Time Frame
Information gathering on the morning of day 5
Title
Postoperative pain Day 5
Description
The pain will be measured from the collection of an intensity measured on a simple 11-point numerical scale (ENS) ranging from "0 = no pain" to "10 = the worst pain imaginable"
Time Frame
Information gathering on the evening of day 5
Secondary Outcome Measure Information:
Title
Explanatory variable 1: Pain Sensitive Questionnaire
Description
The Pain Sensitivity Questionnaire (PSQ) is a self-administered questionnaire comprising 17 items, each rated from 0 to 10. items n° 3-6-7-10-11-12-14 evoke moderately painful situations (and their sum makes it possible to calculate a "minor" PSQ score), and items n° 1-2-4-8- 15-16-17 evoke clearly painful situations (and their sum makes it possible to calculate a "moderate" PSQ score). The sum of these two scores is the "total" PSQ score. As each response to each item ranges from 0 to 10, the minimum value for all scores is 0, and the maximal ones for the minor, the moderate and the total PSQ scores are respectively 7, 7 and 14. The higher the scores, the higher the sensitivity to pain.
Time Frame
1 time only before surgery
Title
Explanatory variable 2: Corah's Dental Anxiety Scale (CDAS)
Description
Corah's Dental Anxiety Scale is based on 4 main questions and calculates a score from 5 to 20 (0-8: no anxiety; 9-12: moderate anxiety; 13-14: high anxiety; 15-20: severe anxiety)
Time Frame
1 time only before surgery
Title
Explanatory variable 3: Pain Catastrophizing Scale (PCS)
Description
Pain Catastrophizing Scale is based on 13 questions that cover 3 representative domains of dramatization: exaggeration of the pain felt (magnification), the tendency to constantly meditate on the pain (rumination) and the feeling of abandonment or lack of associated support (helplessness). As each response to each of the 13 responses items ranges from 0 to 4, the minimum value for the PCS score is 0, and the maximal is 52. The higher the score, the higher the level of pain catastrophizing.
Time Frame
1 time only before surgery
Title
Explanatory variable 4: Gender
Description
Gender will be determined between male or female subject
Time Frame
1 time only before surgery
Title
Explanatory variable 5: Eye color
Description
The color of the iris will be determined by the scale of Martine and Schultz: Light tones: 1-2: Blue 3: Blue gray 4: Gray 5: Blue-gray with yellow/brown spots 6: Grey-green with yellow/brown spots 7: Green 8: Green with yellow/brown spots 9-10-11: Light brown or hazelnut brown Dark tones: 12-13: Brown 14-15: Dark brown to black
Time Frame
1 time only before surgery
Title
Explanatory variable 6: Hair color
Description
Hair color will be determined by color: Black Brown Blond Red
Time Frame
1 time only before surgery
Title
Explanatory variable 7: Blood group
Description
The blood group will be determined by the groups: O HAS B AB as well as Rhesus + or -
Time Frame
1 time only before surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient, male or female, eligible for dental extraction under local anesthesia, either a tooth on the arch, either wisdom tooth(s) (2 homolateral wisdom teeth (maxilla + mandibular) or a mandibular wisdom tooth). Fluent in speaking and reading French. Able to give informed consent to research. Affiliation to a Social Security scheme. Exclusion Criteria: Pregnant or breastfeeding women. Contraindication to paracetamol, NSAIDs, tramadol, or anesthetic agents local. Patient uncooperative, unlikely or unable to comply with all procedures of the protocol. Chronic use of opiates, in a therapeutic or illicit context. Chronic depression on long-term antidepressants. Stomatological pathology that may interfere with the conduct of the intervention or modify the results: insufficient mouth opening, pathologies of the temporal mandibular joints ... Active medical pathology, or any medical condition judged by the investigator to be incompatible with the study. Patient under guardianship, curatorship or safeguard of justice. Refusal to participate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Devoize
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Laurent Devoize

12. IPD Sharing Statement

Learn more about this trial

Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively (PHEDOPO)

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