UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046602 |
|---|---|
| Receipt number | R000053161 |
| Scientific Title | Nursing intervention to relieve physical and mental distress in patients undergoing lumbar puncture |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2022/01/11 20:34:25 |
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Basic information
Public title
Nursing intervention to relieve physical and mental distress in patients undergoing lumbar puncture
Acronym
Nursing intervention to relieve physical and mental distress in patients undergoing lumbar puncture
Scientific Title
Nursing intervention to relieve physical and mental distress in patients undergoing lumbar puncture
Scientific Title:Acronym
Nursing intervention to relieve physical and mental distress in patients undergoing lumbar puncture
Region
| Japan |
Condition
Condition
Neuromuscular disease
Classification by specialty
| Neurology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patients undergoing lumbar puncture, puncture and compulsion are performed by thoroughly implementing nursing interventions such as explanation of examination using visual media, experience of forced posture, body pressure distribution using body mating pillow, and active communication during examination. The purpose was to clarify whether the physical distress caused by the position and the mental distress such as anxiety and fear of the examination could be alleviated. Furthermore, by implementing the above nursing intervention for lumbar puncture, which is frequently performed in the ward, it will lead to improvement of nurses' skills, change of consciousness toward conventional care, and unification of nursing care regardless of years of experience. The purpose was to clarify whether or not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient's anxiety (mood questionnaire, free description: satisfaction with nurse's test explanation / voice, difficulty in posture during test, request in test)
Key secondary outcomes
Pain during patient examination (face rating scale, number of punctures, treatment time, free remarks about pain)
Unification of care among nurses in lumbar puncture, understanding of care, change of consciousness
(Free description: Examination explanation, understanding of patient's anxiety, positioning experience and explanation, environment maintenance, examination
Voice inside, achievement of touching during examination, unification of nursing care, use of personal procedure manual
Whether or not it is used, points that it does not have, deepening understanding, deepening understanding of patients, possession of materials that I would like to use in the future
Nothing)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Implement a program to relieve the pain of lumbar puncture. ((1) Examination explanation using visual media, (2) Experience of forced posture, (3) Thorough nursing care by using checklist)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Patient>
1. Men and women over 20 years old in the 2nd ward on the 7th floor of the north wing of Kyushu University Hospital
2. Patients with written consent
3. Patients undergoing lumbar puncture for the first time
<Nurse>
All nurses who obtained the consent of the 2nd ward on the 7th floor of the north wing
Key exclusion criteria
If any one of the following applies, it will be excluded from the target.
<Patient>
1. Patients with cognitive decline and disorientation
2. Patients with behaviors or dangerous behaviors that deviate from the instructions of the nurse
3. Patients who are judged by researchers to be mentally unstable, such as having a very strong fear of testing
4. Other patients who the researcher finds difficult to participate in the research
<Nurse>
North Building 7th Floor 2 Ward Nurse Chief
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Watanabe |
Organization
Kyushu University Hospital
Division name
Nursing Department
Zip code
812-8582
Address
1-3-3,Maidashi,Higashi-ku,Fukuoka-shi,Fukuoka
TEL
090-642-5954
watanabe.noriko.331@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masumi |
| Middle name | |
| Last name | Akiyoshi |
Organization
Kyushu University Hospital
Division name
North Building 7th Floor 2 Wards
Zip code
812-8582
Address
1-3-3,Maidashi,Higashi-ku,Fukuoka-shi,Fukuoka
TEL
092-642-5727
Homepage URL
akiyoshi.masumi.969@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Hospital
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
Kyushu University Hospital Clinical Trial Ethics Review Board
Address
1-3-3,Maidashi,Higashi-ku,Fukuoka-shi,Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
| 2022 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 01 | Month | 11 | Day |
Last modified on
| 2022 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053161
| 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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| Registered date | File name |
