UMIN-CTR Clinical Trial

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
Email	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
Email	akiyoshi.masumi.969@m.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053161

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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