UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054073 |
|---|---|
| Receipt number | R000061694 |
| Scientific Title | A feasibility trial of tele-group hypnosis for individuals with chronic pain |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/10/06 10:00:42 |
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Basic information
Public title
A feasibility trial of tele-group hypnosis for individuals with chronic pain
Acronym
RESPECT Feasibility
Scientific Title
A feasibility trial of tele-group hypnosis for individuals with chronic pain
Scientific Title:Acronym
REviving Self in individuals with Pain Clinical Trial (RESPECT): a feasibility trial
Region
| Japan |
Condition
Condition
Chronic Pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct a phase I trial to examine the feasibility of the tele-group hypnosis plus usual care for individuals with chronic pain.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the feasibility of the tele-group hypnosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Feasibility of tele-group hypnosis
We evaluated the feasibility based on the following three points.
1. Recruitment rate of participants
2. Retention rate of participants
3. Engagement rate for the trial treatment
Key secondary outcomes
Change in average pain intensity in the last week from the pre- to post-interventions.
Change in worst pain intensity in the last week from the pre- to post-interventions.
Change in pain interference from the pre- to post-interventions.
Change in depression from the pre- to post-interventions.
Change in anxiety from the pre- to post-interventions.
Change in stress from the pre- to post-interventions.
Change in insomnia from the pre- to post-interventions.
Change in behavioral inhibition system from the pre- to post-interventions.
Change in behavioral activation system from the pre- to post-interventions.
Change in pain catastrophizing from the pre- to post-interventions.
Change in pain self-efficacy from the pre- to post-interventions.
Responsiveness assessed by the decrease in average pain intensity in the last week.
Responsiveness assessed by the decrease in worst pain intensity in the last week.
Acceptability of intervention (assessed by the semi-structured interview at the post-intervention time point).
Change in pain intensity from pre- to post-session.
Topological feature changes in correlations of subjective symptoms (anxiety/depression, pain, pain catastrophizing, pain self-efficacy) as measured by the Ecological Momentary Assessment at the pre-and post-interventions.
Change in sleep index (sleep duration, sleep latency, sleep efficiency, and number of awakenings during sleep) from the pre- to post-interventions.
Change in activity from the pre- to post-interventions.
Change in circadian rhythm from the pre- to post-interventions.
Change in heart rate from the pre- to post-interventions.
Homework engagement rate during the trial treatment phase.
Occurrence of adverse events during the observation period.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Treatment as usual plus tele-group hypnosis
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
1. Having pain lasting at least three months.
2. Having a certain level of pain intensity in the last week at the screening.
3. Assuming no change in the contents of treatment as usual during the study participation.
4. At least the age of 18 years.
5. Having the ability to read, write, and understand Japanese.
6. Being able to give free and voluntary written consent to participate in this study.
7. Attending the institutions where the present study is being conducted.
Key exclusion criteria
1. Receiving other psychotherapies.
2. Having experience of receiving hypnosis to treat pain.
3. Receiving or planning to start medical examination or treatment beyond the scope of the treatment as usual during the present study.
4. Having litigation about pain problems.
5. Having a diagnosis of cancer.
6. Having severe cognitive impairment.
7. Having psychiatric problems that would interfere with the study participation currently or within the last 6 months.
8. Being pregnant or having the possibility of being pregnant.
9. Having experience of adverse events by hypnotic induction, or indicating adverse events to hypnotic induction in the present, such as severe symptom aggravation or distress.
10. For any other reason deemed inappropriate by the medical doctor in charge.
Target sample size
13
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
078-803-7797
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
078-803-7797
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
関西医科大学医学部附属病院（大阪府）、広島大学医学部附属病院（広島県）、滋賀医科大学医学部附属病院（滋賀県）、神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | 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
| 2024 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 04 | Month | 05 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061694
