UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045016 |
|---|---|
| Receipt number | R000051421 |
| Scientific Title | Study for effectiveness of psychological intervention to prepare pediatric patients for echo-guided percutaneous renal biopsy under local anesthesia |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2023/03/16 17:44:01 |
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Basic information
Public title
Interventional study to prepare children psychologically for renal biopsy
Acronym
Renal biopsy preparation in children
Scientific Title
Study for effectiveness of psychological intervention to prepare pediatric patients for echo-guided percutaneous renal biopsy under local anesthesia
Scientific Title:Acronym
Effectiveness of psychological intervention to prepare pediatric patients for echo-guided percutaneous renal biopsy under local anesthesia
Region
| Japan |
Condition
Condition
Pediatric patients required echo-guided percutaneous renal biopsy under local anesthesia
Classification by specialty
| Nephrology | Pediatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate effectiveness of psychological preparation specified to pediatric patients undergoing echo-guided percutaneous renal biopsy under local anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Face Scale
2. STAIC
3. CHEOPS
4. heart rate variability
(R-R interval, Heart Rate)
5. Questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
- Patients are assessed through play with HPS.
- Patients read through preparation book on their own.
- Patients are accompanied by HPS during biopsy.
Duration: 4 days
Interventions/Control_2
- Patients are assessed through play with HPS.
- Patients read through preparation book, simulate receiving biopsy, practice breath holding with HPS, and have a briefing on absolute bed rest from HPS.
- Patients are accompanied by HPS during biopsy.
Duration: 4 days
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
| 6 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Patients required renal biopsy
-Patients who are able to have echo-guided percutaneous renal biopsy awake under local anesthesia
Key exclusion criteria
- Patients underwent renal biopsy under general anesthesia
- Patients who do not provide consent by their guardian
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Kobayashi |
Organization
Gunma University Hospital
Division name
Department of Pediatrics
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-7111
kobayasu@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Kobayashi |
Organization
Gunma University Hospital
Division name
Department of Pediatrics
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-7111
Homepage URL
kobayasu@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical committee on Medical and Health Research Involving Human Subject
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
| 2021 | Year | 07 | Month | 30 | 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
| 2021 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | 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
| 2021 | Year | 07 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051421
