UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060131 |
|---|---|
| Receipt number | R000068084 |
| Scientific Title | Proactive Use of Cognitive Behavioral Therapy: Can Preoperative Psychological Intervention Reduce Postoperative Pain After Spine Surgery? |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/19 12:04:31 |
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Basic information
Public title
Proactive Use of Cognitive Behavioral Therapy: Can Preoperative Psychological Intervention Reduce Postoperative Pain After Spine Surgery?
Acronym
Proactive Use of Cognitive Behavioral Therapy: Can Preoperative Psychological Intervention Reduce Postoperative Pain After Spine Surgery?
Scientific Title
Proactive Use of Cognitive Behavioral Therapy: Can Preoperative Psychological Intervention Reduce Postoperative Pain After Spine Surgery?
Scientific Title:Acronym
Proactive Use of Cognitive Behavioral Therapy: Can Preoperative Psychological Intervention Reduce Postoperative Pain After Spine Surgery?
Region
| Japan |
Condition
Condition
Spinal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Orthopaedic Association back pain evaluation questionnaire (JOABPEQ)
Key secondary outcomes
Pain Catastrophizing Scale (PCS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | 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 sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Kawaguchi |
Organization
University of Toyama
Division name
Department of Orthopaedic Surgery
Zip code
930-0194
Address
2630 Sugitani,Toyamashi,Toyama,Japan
TEL
076-434-7353
zenji@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Mizukami |
Organization
University of Toyama
Division name
Department of Orthopaedic Surgery
Zip code
930-0194
Address
2630 Sugitani,Toyamashi,Toyama,Japan
TEL
076-434-7353
Homepage URL
yk1022@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama, Research Ethics Office for Human Subjects
Address
2630 Sugitani,Toyamashi,Toyama,Japan
Tel
076-415-8857
kenrinri@adm.u-toyama.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068084
