UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055456 |
|---|---|
| Receipt number | R000063329 |
| Scientific Title | The effectiveness of short-term mindfulness meditation intervention for acute pain in patients with distal radius fractures: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2024/09/08 |
| Last modified on | 2024/09/08 07:00:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effectiveness of short-term intervention using mindfulness meditation for acute pain in patients with distal radius fractures
Acronym
The effectiveness of short-term mindfulness meditation intervention
Scientific Title
The effectiveness of short-term mindfulness meditation intervention for acute pain in patients with distal radius fractures: a pilot randomized controlled trial
Scientific Title:Acronym
The effectiveness of short-term mindfulness meditation intervention
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of a short-term mindfulness meditation intervention in patients with acute pain following distal radius fracture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain intensity and pain discomfort will be assessed using the Numerical Rating Scale (NRS) before and after the intervention.
Key secondary outcomes
Before and after the intervention, the abbreviated Profile of Mood States-2 (POMS2), the Pain Catastrophizing Scale (PCS), and the range of motion of the wrist joint (palmar flexion and dorsiflexion) will be measured.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group) After undergoing regular rehabilitation, patients will also undergo mindfulness meditation for four days starting on the fourth day after surgery. Meditation will be performed in a quiet private room, with the patient sitting in a chair with their affected limb in a comfortable position. With earphones attached, a tablet will be used to perform mindfulness meditation based on audio guidance for 15 minutes each time. For the mindfulness meditation used this time, breathing meditation will be used, in which the patient closes their eyes and focuses their attention on their own calm breathing.
Interventions/Control_2
Control group) Only standard rehabilitation is performed.
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
Patients who were hospitalized at the Japanese Red Cross Nagasaki Genbaku Hospital, diagnosed with a distal radius fracture, underwent osteosynthesis surgery, and provided informed consent for this study.
Key exclusion criteria
1) Subjects with a history of stroke, 2) Subjects with neurological symptoms in the upper limbs, 3) Subjects with psychiatric disorders or reduced cognitive function (HDS-R score of 20 or less), 4) Subjects who are medically unsuitable for the experiment, and 5) Subjects who did not give consent.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Shoyama |
Organization
Japanese Red Cross Nagasaki Genbaku Hospital
Division name
Rehabilitation Department
Zip code
852-8104
Address
3-15,Mori-machi,Nagasaki-shi,Nagasaki-ken
TEL
095-847-1511
bb55324016@ms.nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Shoyama |
Organization
Japanese Red Cross Nagasaki Genbaku Hospital
Division name
Rehabilitation Department
Zip code
852-8104
Address
3-15,Mori-machi,Nagasaki-shi,Nagasaki-ken
TEL
095-847-1511
Homepage URL
bb55324016@ms.nagasaki-u.ac.jp
Sponsor or person
Institute
Japanese Red Cross Nagasaki Genbaku Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-Procurement
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
Clinical Ethics Committee of the Japanese Red Cross Nagasaki Genbaku Hospital
Address
3-15,Mori-machi,Nagasaki-shi,Nagasaki-ken
Tel
095-847-1511
bb55324016@ms.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 05 | 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
| 2024 | Year | 09 | Month | 08 | Day |
Last modified on
| 2024 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063329
