- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07851233
Patient Education and Sling Use After Shoulder Surgery
Evaluation of Educational Pamphlets and Female Patient Experience With Post-operative Sling-Wear
This study will evaluate whether educational pamphlets can help patients safely manage personal hygiene, household activities, and female-specific self-care while wearing a sling after surgery. The study will also examine whether following sling-use instructions is associated with better short-term recovery and patient-reported outcomes for up to 6 months after surgery.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19107
- Rothman Orthopaedic Institute
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants scheduled to undergo shoulder surgery at Rothman Orthopaedics that requires more than 1 week of postoperative shoulder sling use.
- Participants who are able to provide informed consent.
- Participants who have sufficient English-language proficiency to understand the study materials and complete the study questionnaires.
Exclusion Criteria:
- Participants undergoing shoulder surgery that does not require more than 1 week of postoperative shoulder sling use.
- Participants who do not have sufficient English-language proficiency to understand the study materials and complete the study questionnaires.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Control Group - Standard postoperative education
Standard postoperative education |
Participants will receive the standard postoperative education and instructions provided by their treating orthopedic physician for patients undergoing shoulder surgery requiring postoperative sling use. |
|
활성 비교기: Pamphlet Intervention Group
Standard postoperative education + "Living with a Sling" educational pamphlets |
Participants will receive standard postoperative education plus educational pamphlets providing guidance on performing daily activities while wearing a shoulder sling. The pamphlets address personal hygiene, household tasks, and self-care. Female participants will also receive a pamphlet addressing female-specific self-care. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sling adherence
기간: 4 to 6 weeks after surgery
|
Sling adherence will be assessed using patient-reported survey responses regarding adherence to prescribed shoulder sling use during the postoperative period. |
4 to 6 weeks after surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient-reported shoulder function
기간: 6 months after surgery
|
Shoulder function will be assessed using the American Shoulder and Elbow Surgeons (ASES) score. |
6 months after surgery
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient-reported shoulder status
기간: 6 months after surgery
|
Patient-reported shoulder status will be assessed using the Single Assessment Numeric Evaluation (SANE). |
6 months after surgery
|
|
Patient experience while wearing a shoulder sling
기간: 6 weeks after surgery
|
Participants will complete a questionnaire assessing their experience performing daily activities, including personal hygiene, household tasks, and self-care while wearing a shoulder sling. |
6 weeks after surgery
|
|
Preparedness for postoperative activities
기간: 6 weeks after surgery
|
Participants will report their preparedness and ability to manage daily activities while wearing a shoulder sling. |
6 weeks after surgery
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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 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. .