Tokyo, Dec. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060131) titled 'Proactive Use of Cognitive Behavioral Therapy: Can Preoperative Psychological Intervention Reduce Postoperative Pain After Spine Surgery?' on Dec. 22.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - University of Toyama

Condition: Condition - Spinal stenosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to compare treatment outcomes between patients who receive cognitive behavioral therapy (CBT) before spinal surgery and those who do not. This study aims to investigate whether the application of CBT from the preoperative period improves surgical outcomes and to examine the significance of preoperative CBT. In addition, patient characteristics for whom CBT is effective will be explored. If preoperative CBT is shown to be effective, it is expected that implementing psychological interventions from the preoperative stage may help prevent postoperative pain and its chronification in the future. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Cognitive behavioral therapy (CBT) will be conducted once preoperatively and twice during postoperative hospitalization, with each session lasting approximately 40-50 minutes. Participants will complete questionnaires assessing outcome measures (approximately 10 minutes) at the following time points: preoperatively (Visit 1), 3 months postoperatively (Visit 2), 6 months postoperatively (Visit 3), 1 year postoperatively (Visit 4), and 2 years postoperatively (Visit 5). Surgical outcomes will be evaluated based on these assessments. Interventions/Control_2 - Participants in the control group who do not receive CBT will be asked to complete questionnaires assessing outcome measures (approximately 10 minutes) at the following time points: preoperatively (Visit 1), 3 months postoperatively (Visit 2), 6 months postoperatively (Visit 3), 1 year postoperatively (Visit 4), and 2 years postoperatively (Visit 5). Surgical outcomes will be evaluated based on these assessments.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Patients who will undergo spinal surgery at Toyama University Hospital.

Patients whose pain can be evaluated and whose preoperative Visual Analog Scale (VAS) score is greater than 5.

Patients who are judged to be eligible for this study by the principal investigator (or sub-investigator) based on medical history, physical examination, and clinical assessment.

Patients who have provided written informed consent and who are judged by the principal investigator (or sub-investigator) to be able to comply with the study requirements, undergo the examinations, tests, and surgery necessary for the conduct of this study, and report symptoms during the study period. Key exclusion criteria - Patients who did not provide informed consent to participate in the study.

Patients who have difficulty with verbal communication.

Patients with a history of cognitive impairment or dementia. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 16 Day Anticipated trial start date - 2026 Year 01 Month 05 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068084

Disclaimer: Curated by HT Syndication.