- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07701564
Motion Graphic Training for Scrub Nurses in Hip Surgery
Motion Graphic Video-Based Training and Its Effect on Scrub Nurse Performance During Dynamic Hip Screw Surgery in Iran: A Pilot Randomized Controlled Trial
연구 개요
상태
상세 설명
This is a pilot randomized controlled trial conducted at Valiasr Teaching Hospital, Arak University of Medical Sciences, Iran, from December 2024 to July 2025. The study is designed according to CONSORT guidelines for pilot and feasibility trials.
A total of 30 undergraduate operating room technology students in their 6th or 8th semester are randomly assigned to intervention (n=15) and control (n=15) groups using block randomization with a computer-generated random numbers table. Both groups receive routine clinical training from the same instructor at the beginning of the course. The intervention group additionally views a 15-minute motion graphic video demonstrating DHS surgical steps, which they can watch unlimited times during the 15-day internship period. The video content includes introduction of surgical instruments, anatomy review, surgical table setup, patient preparation and draping, and instrument delivery to the surgeon.
Students' performance as first scrub nurse is assessed twice: on the first day of internship (pre-test) and at the end of the 15-day internship (post-test) by a blinded independent evaluator using a validated 43-item checklist covering preoperative (13 items), intraoperative (24 items), and postoperative (6 items) phases. The checklist has been validated for content validity and reliability through expert review and pilot testing.
To prevent contamination, the control group is enrolled first, and intervention group students are asked not to discuss the educational video with others. The video will be provided to the control group after study completion for educational equity.
Data will be analyzed using paired and independent t-tests. Effect sizes will be calculated for between-group comparisons.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Arak, 이란
- Hamed
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Undergraduate operating room technology student in the 6th or 8th semester
- Completion of the theoretical course in orthopedic operating room technology and care
- Willingness to participate and provide informed consent
Exclusion Criteria:
Withdrawal or unwillingness to continue participation at any stage
- Previous clinical experience in orthopedics that could affect the results
- Absenteeism or insufficient presence during the internship
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Motion Graphic Video Training
Students received a 15-minute motion graphic video demonstrating DHS surgical steps, in addition to routine clinical training, with unlimited access during the 15-day internship.
|
A 15-minute animated video demonstrating the steps of proximal femur fracture surgery using a dynamic hip screw (DHS).
Content includes surgical instruments, anatomy review, table setup, patient draping, and instrument delivery to the surgeon.
|
|
활성 비교기: Routine Clinical Training
Students received only routine clinical training in the operating room, including attending the OR, performing the scrub nurse role, and receiving direct feedback from the clinical instructor during the 15-day internship.
|
Standard clinical training in the operating room including attendance, performing the scrub nurse role, and receiving direct feedback from the clinical instructor during the 15-day internship.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Scrub Nurse Performance Score
기간: Baseline (day 1) and day 15 (end of 15-day internship)
|
Performance assessed using a validated 43-item researcher-made checklist covering preoperative (13 items), intraoperative (24 items), and postoperative (6 items) phases.
Each item is scored on a three-point scale: 0 = does not perform, 1 = performs incompletely, and 2 = performs correctly.
The total score ranges from 0 to 86, with higher scores indicating better performance.
The checklist was validated for content validity and reliability through expert review and pilot testing.
|
Baseline (day 1) and day 15 (end of 15-day internship)
|
|
Within-Group Pre-Post Score Changes
기간: Baseline to day 15
|
Comparison of Scrub Nurse Performance Scores (measured using a validated 43-item checklist, total score range: 0-86, with higher scores indicating better performance) before and after the 15-day internship within each group using paired t-tests.
|
Baseline to day 15
|
|
Between-Group Post-Test Score Comparison
기간: Day 15
|
Comparison of Scrub Nurse Performance Scores (measured using a validated 43-item checklist, total score range: 0-86, with higher scores indicating better performance) between the intervention and control groups after the 15-day internship using independent t-tests.
|
Day 15
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Hamed parnikh, Arak University of Medical Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Arak-DHS-2024
- IR.ARAKMU.REC.1403.219 (기타 식별자: Ethics Committee of Arak University of Medical Sciences)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .