- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06555770
백내장 수술 중 음악과 스트레스 볼 적용이 환자에게 미치는 영향
백내장 수술 중 환자에게 음악과 스트레스 볼 적용이 불안과 통증에 미치는 영향 조사
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Samsun, 터키 (Türkiye)
- Samsun Gazi State Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 18세 이상이며 PHACO 수술을 받고 있는 경우,
- 청각이나 지각에 문제가 없는 경우,
- 스트레스볼을 쥐는데 신체적 문제가 없고,
- 처음으로 백내장 수술을 받았는데,
- 연구에 기꺼이 참여할 의향이 있습니다.
제외 기준:
- 수술 전 24시간 이내에 진통제 또는 항불안제를 사용한 경우,
- 수술 중 국소마취에서 전신마취로 전환,
- 정신과적 진단입니다.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Stress ball
Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward.
State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward.
Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II).
Patients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise.
The stress ball will be used for 15 minutes during cataract surgery.
Patients will be reminded during the procedure to continue the intervention as instructed.
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Patients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise.
The stress ball will be used for 15 minutes during cataract surgery.
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실험적: Music intervention
Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward.
State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward.
Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II).
According to the randomization, patients assigned to the music intervention group will be asked to select their preferred music from a prepared playlist.
The playlist will include 50 tracks representing pop music, Turkish classical music, regional folk music, instrumental music, and religious music.
The selected music will be played for 15 minutes during cataract surgery.
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Patients assigned to the music intervention group will select their preferred music from a prepared playlist.
The selected music will be played for 15 minutes during cataract surgery.
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간섭 없음: Control
Pain levels will be tested with VAS 10 minutes before the surgery, and anxiety levels with the VAS-A and Spielberg Continuous Anxiety Scale.
The patient in the control group will not be given any intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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통증(시각적 아날로그 척도)
기간: 수술 10분 후
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10cm 길이의 수평 또는 수직 눈금자로 등급을 매기고 "0"은 통증이 없음을 의미하고 "10"은 가장 심한 통증을 의미합니다. 환자는 그가 느끼는 고통의 강도를 자에 표시합니다. 표시된 값이 1-4 사이이면 경미한 통증, 5-6 사이는 중등도 통증, 7-10 사이는 심한 통증을 나타냅니다. 응용 프로그램에서 환자는 그가 느낀 통증의 강도를 자에 표시하도록 요청받았고 그 값을 측정하고 기록했습니다. |
수술 10분 후
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Pain (Visual Analog Scale)
기간: Immediately after surgery
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Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded. |
Immediately after surgery
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Anxiety (Visual Analog Scale-Anxiety)
기간: approximately 5-10 minutes before surgery
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Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded. |
approximately 5-10 minutes before surgery
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Anxiety (Visual Analog Scale-Anxiety)
기간: Immediately after surgery
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Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded. |
Immediately after surgery
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Anxiety (Visual Analog Scale-Anxiety)
기간: 10 minutes after surgery
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Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded. |
10 minutes after surgery
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State-Trait Anxiety Inventory (STAI-II)
기간: Approximately 5-10 minutes before surgery
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Trait anxiety will be assessed using the State-Trait Anxiety Inventory-II (STAI-II), which consists of 20 items and measures an individual's general tendency to experience anxiety.
Higher scores indicate higher levels of trait anxiety.
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Approximately 5-10 minutes before surgery
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공동 작업자 및 조사자
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
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