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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Tuğba Yorulmaz, PhD
- Telefonnummer: 4220 +90 216 500 4220
- E-Mail: tugba.yorulmaz@acibadem.edu.tr
Studieren Sie die Kontaktsicherung
- Name: Rabia Muhan Eraslan, MSc
- Telefonnummer: 7707 +90 216 500 7707
- E-Mail: rabia.muhan@acibadem.edu.tr
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Kein Eingriff: Standard Care Group
Participants will receive standard postoperative care without the use of a medical arm sling.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patient Comfort Assessed Using the Visual Analog Comfort Scale
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Tugba Yorulmaz, PhD, Acibadem University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-13/631
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Beschreibung des IPD-Plans
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
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