Tokyo, Jan. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060277) titled 'Verification of the reliability of the Japanese version of the Pediatric Scale for Quality of Recovery (PedSQoR-J) and its impact on life after discharge' on Jan. 7.
Study Type:
Observational
Primary Sponsor:
Institute - Nara Medical University
Condition:
Condition - The main purpose is to examine the reliability of PedSQoR-J. In addition, we will evaluate the feasibility, validity, and responsiveness of PedSQoR-J. We will also evaluate the relationship between PedSQoR-J and intraoperative factors such as surgical procedure and vital signs, as well as the relationship between PedSQoR-J and quality of life after discharge.
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The main purpose is to examine the reliability of PedSQoR-J. In addition, we will evaluate the feasibility, validity, and responsiveness of PedSQoR-J. We will also evaluate the relationship between PedSQoR-J and intraoperative factors such as surgical procedure and vital signs, as well as the relationship between PedSQoR-J and quality of life after discharge.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 2
years-old
Gender - Male and Female
Key inclusion criteria - 5.1. Study Participants
Patients scheduled for surgery at Nara Medical University between study approval and December 2026
5.2. Eligibility Criteria
- Elective surgery
- Ages 2 to 17
- American Society of Anesthesiologists Preoperative Evaluation Class I-III
- Patients whose parents or guardians are the patient's primary caregivers
- Patients who have parental or guardian consent and have obtained assent from the child
Key exclusion criteria - Surgery scheduled to end after 5PM
Emergency surgery
Non native Japanese speakers
Patients with developmental disabilities or psychiatric disorders requiring assistance with daily activities
Patients scheduled to be transferred to the intensive care unit
Patients not scheduled for extubation in the operating room
Target Size - 230
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 07 Day
Anticipated trial start date - 2026 Year 01 Month 13 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068952
Disclaimer: Curated by HT Syndication.