Attentional Re-training for Chronic Pain Patients (ABCD)
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|ClinicalTrials.gov Identifier: NCT04150419|
Recruitment Status : Not yet recruiting
First Posted : November 4, 2019
Last Update Posted : April 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pelvic Perinal Pain||Other: Group 1 Other: Group 2 Other: Group 3 (control group)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of the Effectiveness of a Therapeutic Program for the Attentional Re-training of Chronic Pain Patients: Feasibility of E-care|
|Estimated Study Start Date :||June 15, 2020|
|Estimated Primary Completion Date :||January 15, 2021|
|Estimated Study Completion Date :||January 15, 2021|
Other: Group 1
Attentional training to avoid threatening, negative or pain-related information.
Other: Group 2
Attention training for vigilance for positive emotional information.
|Active Comparator: G3||
Other: Group 3 (control group)
Neutral attentional training (control group).
- To evaluate the effectiveness of a therapeutic program for attentional re-training on the painful feelings of patients with chronic pelvic-perineal pain. [ Time Frame: 3 months ]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).
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): NCT04150419
|Contact: Virginie Quistrebert-Davanne, PhD||+33 2 40 76 80 firstname.lastname@example.org|
|Principal Investigator:||Virginie Quistrebert-Davanne, PhD||Nantes University Hospital Nantes|