search
Back to results

Attentional Re-training for Chronic Pain Patients (ABCD)

Primary Purpose

Chronic Pelvic Perinal Pain

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Group 1
Group 2
Group 3 (control group)
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pelvic Perinal Pain focused on measuring Attentional bias modification training, chronic pelvi-perinal pain.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic pain patients, i.e., chronic pain that has been ongoing for more than 3 months.
  • Patient follow-up in the urology department of the University Hospital of Nantes
  • Age between 18 and 65
  • Good understanding of French, able to read and write.
  • Serve correctly and painlessly with both hands
  • Affiliated with a social security system
  • Signed consent
  • With internet access.

Exclusion Criteria:

  • Current and unstable psychiatric (mood disorders, anxiety disorders) and addictive (substance use disorders, alcoholic or otherwise, excluding nicotine) disorders.
  • Does not use both hands properly and painlessly
  • Depression (BDI-II ≤18)
  • Patient under guardianship, curatorship or judicial protection
  • Pregnant or breastfeeding woman

Sites / Locations

  • CHU Nantes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

G1

G2

G3

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the effectiveness of a therapeutic program for attentional re-training on the painful feelings of patients with chronic pelvic-perineal pain.
Variation in pain assessed from the numerical scale. The Numerical Pain Rating Scale measures the perception of pain intensity with an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

Secondary Outcome Measures

Full Information

First Posted
October 17, 2019
Last Updated
December 15, 2022
Sponsor
Nantes University Hospital
Collaborators
Fondation Apicil
search

1. Study Identification

Unique Protocol Identification Number
NCT04150419
Brief Title
Attentional Re-training for Chronic Pain Patients
Acronym
ABCD
Official Title
Evaluation of the Effectiveness of a Therapeutic Program for the Attentional Re-training of Chronic Pain Patients: Feasibility of E-care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulties
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
December 6, 2022 (Actual)
Study Completion Date
December 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Fondation Apicil

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
Hyper-vigilance, focusing, avoidance are part of the vocabulary used by the clinician who deals with chronic pain. These notions refer to the functioning and dysfunction of so-called "selective" attention. These "selective attentional biases" are believed to be responsible, in part, for the development and maintenance of negative pain-related thoughts (such as catastrophic thoughts), inappropriate behaviours (such as inactivity and fear of movement) and unpleasant emotions (such as stress or anger). In addition, they would also be a powerful indicator of the onset of post-operative pain and could limit the effectiveness of therapeutic management. Therapeutically, attention bias can be "managed" through attentional re-training techniques (ABMs) that teach patients to direct their attention differently. These techniques have been widely validated in anxious or addictive populations but have never been used to date in chronic pain patients. This home-based attention bias management (e-retraining) would represent, for chronic pain patients, an additional tool aimed not only at reducing their pain but also at achieving other associated factors such as anxiety, stress, catastrophic thoughts, avoidance behaviours and quality of life.
Detailed Description
After obtaining the patients' agreement, they will be randomized in one of the 3 experimental groups: G1: Attentional training to avoid threatening, negative or pain-related information. G2: Attention training for vigilance for positive emotional information. G3: neutral attentional training (control group). The study will be conducted from the patient's home via a connection to the protected site of the Nantes University Hospital. The various questionnaires will be completed from the secure site of the Nantes University Hospital and the computerized experimental tasks will be carried out using the Inquisit software (WEB version at home). The study will begin with an evaluation of the patients' attention and psychological processes (completion of questionnaires + 2 attention tasks), during a follow-up visit to the urology department of the University Hospital of Nantes. Then, an 8-week attentional re-training program (2 training sessions per week) will be proposed. At the end of the 8 weeks, an evaluation (Questionnaires + attention tasks) will be offered to patients always from home. Finally, a final evaluation, 4 weeks after the end of the re-training, will always be proposed from the patient's home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Perinal Pain
Keywords
Attentional bias modification training, chronic pelvi-perinal pain.

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G1
Arm Type
Experimental
Arm Title
G2
Arm Type
Experimental
Arm Title
G3
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Group 1
Intervention Description
Attentional training to avoid threatening, negative or pain-related information.
Intervention Type
Other
Intervention Name(s)
Group 2
Intervention Description
Attention training for vigilance for positive emotional information.
Intervention Type
Other
Intervention Name(s)
Group 3 (control group)
Intervention Description
Neutral attentional training (control group).
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of a therapeutic program for attentional re-training on the painful feelings of patients with chronic pelvic-perineal pain.
Description
Variation in pain assessed from the numerical scale. The Numerical Pain Rating Scale measures the perception of pain intensity with an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic pain patients, i.e., chronic pain that has been ongoing for more than 3 months. Patient follow-up in the urology department of the University Hospital of Nantes Age between 18 and 65 Good understanding of French, able to read and write. Serve correctly and painlessly with both hands Affiliated with a social security system Signed consent With internet access. Exclusion Criteria: Current and unstable psychiatric (mood disorders, anxiety disorders) and addictive (substance use disorders, alcoholic or otherwise, excluding nicotine) disorders. Does not use both hands properly and painlessly Depression (BDI-II ≤18) Patient under guardianship, curatorship or judicial protection Pregnant or breastfeeding woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginie Quistrebert-Davanne, PhD
Organizational Affiliation
Nantes University Hospital Nantes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44400
Country
France

12. IPD Sharing Statement

Learn more about this trial

Attentional Re-training for Chronic Pain Patients

We'll reach out to this number within 24 hrs