UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052930 |
|---|---|
| Receipt number | R000059724 |
| Scientific Title | A feasibility trial of hypnotic analgesia and cognitive hypnotherapy for chronic neuropathic pain with a single-case design |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/04/25 15:25:53 |
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Basic information
Public title
A feasibility trial of hypnotic analgesia and cognitive hypnotherapy for chronic neuropathic pain with a single-case design
Acronym
J-POP study
Scientific Title
A feasibility trial of hypnotic analgesia and cognitive hypnotherapy for chronic neuropathic pain with a single-case design
Scientific Title:Acronym
J-POP study
Region
| Japan |
Condition
Condition
Chronic Neuropathic Pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to test the efficacy and safety of hypnotic analgesia and cognitive hypnotherapy on pain intensity in individuals with chronic neuropathic pain by a phase I trial using a single-case design.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Average pain intensity for the last 24 hours in the intervention and follow-up phases.
Key secondary outcomes
Maximum pain intensity for the last 24 hours.
Average and maximum pain intensity for the last week.
Pain interference,
Psychological distress,
Pain catastrophizing,
Pain self-efficacy,
Decentering,
Readiness for pain self-management.
All these outcomes will be evaluated in the intervention and follow-up phases.
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We offer the 4 sessions of hypnotic analgesia adding to treatment as usual as an intervention group no. 1. The following hypnotic suggestions are provided: (1) Decrease of unpleasant sensation, (2) Imagined anesthesia, (3)Metaphor of marble, (4) Increased awareness of comfort and comfortable sensation.
Interventions/Control_2
We offer the 4 sessions of cognitive hypnotherapy adding to treatment as usual as an intervention group no. 2. The following hypnotic suggestions are provided: (1) Building a response set concerning ambiguity, (2)Suggestions that make the altering alarming thoughts into reasonable ones, (3)Metaphor of marble as an object to externalize worries or negative thoughts, (4)Age progression.
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
1) Having neuropathic pain.
2) Lasting neuropathic pain for at least 3 months.
3) Having a score of at least 3 points in the interview part of the DN4 Japanese version.
4) Having a score of at least 3 points on the Numerical Rating Scale measuring average pain in the last week.
5) Capable of continuing the current treatment's content as well as possible during the present trial.
6) Aged at least 18 years.
7) Having the ability to read, write, and speak Japanese.
8) Capable of obtaining written informed consent to participate in the present study based on the participants' free will.
9) Attending Shiga University of Medical Science Hospital.
Key exclusion criteria
1) Currently receiving other psychotherapy.
2) Having experience receiving more than 4 sessions of hypnosis for pain treatment in the past.
3) Currently undergoing or planning to undergo new tests or treatments beyond the scope of usual care during the study period.
4) Cancer pain.
5) Complex regional pain syndrome type I.
6) Severe cognitive dysfunction.
7) Psychiatric problems that would preclude participation in the study now or in the past 6 months.
8) Pregnant.
9) Patients considered inappropriate to participate in the study by a doctor in charge.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Adachi |
Organization
Kobe University
Division name
Graduate School of Human Development and Environment
Zip code
657-8501
Address
3-11 Tsurukabuto, Nada, Kobe, Hyogo, JAPAN
TEL
078-803-7905
tadachi@people.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Adachi |
Organization
Kobe University
Division name
Graduate School of Human Development and Environment
Zip code
657-8501
Address
3-11 Tsurukabuto, Nada, Kobe, Hyogo, JAPAN
TEL
078-803-7905
Homepage URL
tadachi@people.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University hospital Clinical Trial Research Center
Address
7-5-2, Kusunoki-cho, Chyuoh-ku, Kobe city
Tel
078-382-6669
kainyu@med.kobe-u.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
滋賀医科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | 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 | 12 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 11 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059724
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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