UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052501 |
|---|---|
| Receipt number | R000059913 |
| Scientific Title | Epidemiology and Awareness of Chronic Postsurgical Pain - Web Survey of Healthcare Professionals and Surgery Survivors |
| Date of disclosure of the study information | 2023/10/14 |
| Last modified on | 2023/10/14 18:16:18 |
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Basic information
Public title
Epidemiology and Awareness of Chronic Postsurgical Pain - Web Survey of Healthcare Professionals and Surgery Survivors
Acronym
Survey of Chronic Postsurgical Pain
Scientific Title
Epidemiology and Awareness of Chronic Postsurgical Pain - Web Survey of Healthcare Professionals and Surgery Survivors
Scientific Title:Acronym
Cross-sectional study on chronic postsurgical pain
Region
| Japan |
Condition
Condition
Chronic postsurgical pain
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To understand the current status of chronic postoperative pain in Japan, including the prevalence of chronic postoperative pain, the percentage of patients receiving treatment, and the level of awareness, by conducting a web-based survey of the general public with a history of surgery.
(2) To understand the current status of the chronic postoperative pain treatment system in Japan by surveying the status of information provision to surgical patients with chronic postoperative pain and their experience of treatment.
Basic objectives2
Others
Basic objectives -Others
Epidemiological and awareness survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(For patients who have undergone surgery)
Incidence of chronic postoperative pain and awareness of chronic postoperative pain
(Healthcare professionals)
Rate of providing information on chronic postoperative pain to patients in the preoperative to acute postoperative period
Key secondary outcomes
(For patients who have undergone surgery)
Factors associated with the development of chronic postoperative pain
(Healthcare professionals)
Treatment of chronic postoperative pain (drugs used, non-pharmacological treatments)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who have undergone surgery for more than 3 months
Healthcare professionals: Members of the Japan Society for the study of Postoperative Pain Medicine and the Japan Society of Pain Clinicians
Key exclusion criteria
Persons with surgical experience: Persons who have undergone surgery less than 3 months after surgery, treatment that does not require incision of the skin.
Medical personnel: Those who work in research and are not involved in patient care.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | YOKO |
| Middle name | |
| Last name | SUGIYAMA |
Organization
Central Japan International Medical Center
Division name
Anesthesiology and Pain Relief Center
Zip code
505-8510
Address
1-1, Kenko no Machi, Minokamo City, Gifu, Japan
TEL
0574-66-1100
sugiyama.yoko@cjimc-hp.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Sugiyama |
Organization
Central Japan International Medical Center
Division name
Anesthesiology and Pain Relief Center
Zip code
505-8510
Address
1-1, Kenko no Machi, Minokamo City, Gifu, Japan
TEL
0574-66-1100
Homepage URL
sugiyama.yoko@cjimc-hp.jp
Sponsor or person
Institute
Central Japan International Medical Center Anesthesiology and Pain Relief Center
Institute
Department
Personal name
Funding Source
Organization
Pfizer
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
US
Other related organizations
Co-sponsor
Name of secondary funder(s)
Gifu University Graduate School of Medicine
IRB Contact (For public release)
Organization
Ethics Committee of Central Japan International Medical Center
Address
1-1, Kenko no Machi, Minokamo City, Gifu, Japan
Tel
0574-66-1100
N/A
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
| 2023 | Year | 10 | Month | 14 | 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
| 2023 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study using a web-based questionnaire
(Survey of patients who had undergone surgery)
Questions: Gender, age (stratified options), smoking history, presence of preoperative chronic pain, comorbidities, surgical site, severity of acute postoperative pain, severity of postoperative pain at discharge, presence of chronic postoperative pain (3 months after surgery), presence of chronic postoperative pain treatment, awareness of chronic postoperative pain, experience of receiving information on chronic postoperative pain
Data collection method: This study was commissioned to Rakuten Insight, Inc.
(Survey of healthcare professionals)
Questionnaire items: Job title, years of clinical experience, department, existence of postoperative pain management team, existence of additional postoperative pain management team, awareness of chronic postoperative pain, status of information provision on chronic postoperative pain, pain management system after discharge, experience in chronic postoperative pain treatment, drugs used in chronic postoperative pain treatment, non-drug therapies used in chronic postoperative pain treatment, and chronic postoperative pain treatment. therapy, and difficulties in the treatment of chronic postoperative pain.
Data collection method: The Japanese Society of Postoperative Pain Medicine secretariat and the Japan Pain Clinic Society secretariat will invite the members of the societies to participate in this study via e-mail, etc., and respondents who agree to participate will access the questionnaire form from the URL or QR code in the e-mail and fill out the questionnaire voluntarily. This study will be conducted with the approval of the board of directors of each society.
Management information
Registered date
| 2023 | Year | 10 | Month | 14 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059913
| Research Plan | |
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