Attentional Re-training for Chronic Pain Patients

NCT04150419 | Terminated

• 1 other identifier: RC18_0361
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pelvic Perinal Pain

Keywords

Attentional bias modification training; chronic pelvi-perinal pain.

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Study Arms (3)

G1

EXPERIMENTAL

Other: Group 1

G2

EXPERIMENTAL

Other: Group 2

G3

ACTIVE COMPARATOR

Other: Group 3 (control group)

Interventions

Group 1 OTHER

Attentional training to avoid threatening, negative or pain-related information.

G1

Group 2 OTHER

Attention training for vigilance for positive emotional information.

G2

Group 3 (control group) OTHER

Neutral attentional training (control group).

G3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Fondation Apicil: collaborator

Study Sites (1)

CHU Nantes

Nantes, 44400, France

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Virginie Quistrebert-Davanne, PhD

  Nantes University Hospital Nantes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: November 4, 2019
• Study Start: October 15, 2021
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

FR (1)