Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement (CIED-SLING24)
The Effect of Short-Term Arm Sling Use During the First 24 Hours After Implantation of a Cardiac Electronic Device on Patient Comfort, Pain, Satisfaction, and Early Device-Related Complications: A Randomized Controlled Trial
This randomized controlled trial will evaluate the effects of short-term medical arm sling use during the first 24 hours after cardiac implantable electronic device (CIED) implantation on patient comfort, pain, satisfaction, and early device-related complications.
Adult patients undergoing first-time implantation of a permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. Patients in the intervention group will receive standard postoperative care and use a medical arm sling on the side of device implantation for 24 hours. Patients in the control group will receive standard postoperative care without an arm sling. Both groups will otherwise receive the same nursing care, including wound monitoring, pain management, and early mobilization education.
Pain and comfort will be assessed during the first 24 hours after implantation. Patient satisfaction with arm sling use will be evaluated in the intervention group at 24 hours. Early device-related complications, including pocket hematoma, bleeding, swelling, wound-related findings, lead dislodgement, device abnormalities, and other early postoperative complications, will be assessed during hospitalization, at discharge, and at the first-week follow-up. Outcome assessments will be performed by an investigator who is blinded to group allocation.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Cardiac implantable electronic devices (CIEDs), including permanent pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices, are widely used in the management of bradyarrhythmias, tachyarrhythmias, and heart failure. The early postoperative period following CIED implantation is important because device-related complications such as pocket hematoma, bleeding, swelling, wound-related problems, and lead-related complications may occur during this period.
Postoperative restriction of arm movement and the use of an arm sling are commonly applied in clinical practice; however, practices vary considerably between centers, and there is no clear consensus regarding the necessity or optimal duration of arm sling use following CIED implantation. While arm immobilization may provide a sense of protection and may potentially reduce movement-related concerns, unnecessary restriction may also negatively affect comfort, pain, mobility, and the overall patient experience.
Previous studies have mainly focused on device-related complications or shoulder function following CIED implantation. Evidence regarding the effects of short-term medical arm sling use on patient-centered outcomes, particularly comfort, pain, and satisfaction, together with early device-related complications, remains limited. Therefore, this study is designed to provide randomized controlled evidence on the clinical and patient-centered effects of using a medical arm sling during the first 24 hours after CIED implantation.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Tuğba Yorulmaz, PhD
- 전화번호: 4220 +90 216 500 4220
- 이메일: tugba.yorulmaz@acibadem.edu.tr
연구 연락처 백업
- 이름: Rabia Muhan Eraslan, MSc
- 전화번호: 7707 +90 216 500 7707
- 이메일: rabia.muhan@acibadem.edu.tr
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Aged 18 years or older. Undergoing first-time implantation of a permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
Clinically stable during the first 24 hours after the procedure. Able to read, understand, and communicate in Turkish. Willing to participate in the study and provide informed consent.
Exclusion Criteria:
Undergoing device revision, lead replacement, or generator replacement. Presence of an orthopedic or neurological condition that restricts upper-extremity movement.
Presence of cognitive impairment or a communication barrier. Development of a major complication during the implantation procedure. Request to withdraw from the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Medical Arm Sling Group
Participants will receive standard postoperative care and will use a medical arm sling on the side of CIED implantation for 24 hours after the procedure.
|
A medical arm sling will be applied to the upper extremity on the side of CIED implantation immediately after the procedure and will be used for 24 hours.
Participants will receive standardized instructions regarding proper arm sling use.
All other postoperative nursing care will be provided according to the standard care protocol.
|
|
간섭 없음: Standard Care Group
Participants will receive standard postoperative care without the use of a medical arm sling.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient Comfort Assessed Using the Visual Analog Comfort Scale
기간: 2, 6, 12, and 24 hours after CIED implantation
|
Patient comfort will be assessed using a 0-10 Visual Analog Comfort Scale, where 0 indicates "not comfortable at all" and 10 indicates "completely comfortable."
Higher scores indicate greater patient comfort.
|
2, 6, 12, and 24 hours after CIED implantation
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Tugba Yorulmaz, PhD, Acibadem University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2026-13/631
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .