臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 06, 2024
Last modified on	Dec. 06, 2024
Trial ID	jRCT1030240527

Scientific Title	Effect of ward nurses' education on the use of PCA for patients undergoing orthopedic surgery
Public Title	Effect of education on the use of PCA by nurses

Contact for Scientific Queries	Name	Naomi Fujita
	Affiliation	Toho University Omori Medical Center
	Address	6-11-1 Omorinishi, Ota-ku, Tokyo
	Telephone	+81-3-3762-4151
	E-mail	naomi.fujita@ns.toho-u.ac.jp
Contact for Public Queries	Name	Naomi Fujita
	Affiliation	Toho University Omori Medical Center
	Address	6-11-1 Omorinishi, Ota-ku, Tokyo
	Telephone	+81-3-8762-4151
	E-mail	naomi.fujita@ns.toho-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 06, 2024
Target sample size		40
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Patients admitted to the orthopedic ward and undergoing surgery using PCA for postoperative pain management
	Exclusion Criteria	Surgery without PCA. Patients with impaired consciousness (delirium, dementia). Patients who have had their PCA discontinued due to removal, etc. Patients using narcotics due to cancer pain. Patients who are unable to press the dose button themselves due to paralysis or contracture. Patients who were not able to receive preoperative PCA education due to surgery during emergency hospitalization. Minors.
	Age Minimum	18age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Musculoskeletal diseases
Intervention(s)		Instructions for nurses Pain assessment will be performed by ward nurses using a VAS ruler. Ward nurses will be research collaborators. It will be made known that assessments will be standardized using VAS. A VAS ruler will be provided to all nurses so that they can actually use it during the research period. PCA instruction method Education will be given the day before surgery using a pamphlet used in the anesthesiology outpatient clinic and a PCA demo machine. This will be carried out by members of this research so that the quality of PCA use education can be consistent. Patients who have been educated will be noted as "PCA education completed" in the care flow notes column. The content of the education will be explained in simple terms on the following items. Pain management leads to early mobilization and prevention of complications. PCA is a pump that automatically introduces small amounts of painkillers into the body continuously. When pain intensifies, patients can press the button themselves to administer additional painkillers. No matter how many times the button is pressed, there will be no overdose of medication, so please feel free to press it when you are in pain. Recommended times to press the button are when pain begins to intensify, before moving, and before falling asleep. The position of the PCA pump button, the sound it makes when the drug is administered, and when it is lit up, it is the time to administer the drug Please inform the staff if you experience any side effects. Side effects include nausea, dizziness, itching, numbness in the legs, and headaches. Conducting the survey The day before surgery, the study will be explained and consent obtained. At that time, a survey on the effectiveness of PCA use education will be distributed along with a stamped envelope. In addition, it will be explained that the survey will be given an identification number and linked to data from the medical records, and that the study is not compulsory. Surveys posted by Sunday, January 5, 2025 will be the study subjects, and surveys that are not returned or arrive after the deadline will not be included in the study. Multiple choice questions in the survey responses will be quantitative evaluation items, and free-form comments will be qualitative evaluation items. Collect data from medical records The following will be collected as quantitative evaluation items: the progress of VAS up to the second postoperative day, the number of PCA doses, the number of effective PCA doses, the surgical procedure, the type of medication used for PCA, the use of on-demand analgesics, the use of increased regular oral analgesics since surgery, and the presence or absence of postoperative nausea and vomiting (PONV).
Health Condition(s) Keyword		Musculoskeletal
Intervention(s) Keyword		Pain management
Health Condition(s) Code		D046650
Intervention(s) Code		D059408
Primary Outcome(s)		Questionnaire responses, change in VAS up to the second postoperative day, number of PCA doses, number of effective PCA doses, surgical procedure, type of medication used for PCA, use of emergency painkillers, increased use of regular oral painkillers after surgery, and postoperative nausea and vomiting (PONV).

Primary Sponsor	Toho University Omori Medical Center

Name of Certified Review Board	Toho University Omori Medical Center Ethics Committee
Address	6-11-1 Omorinishi, Ota-ku, Tokyo, Tokyo
Telephone	+81-3-5763-6534
E-Mail	omori.rinri@ext.toho-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 03, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none