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Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07810426
Acronym
CIED-SLING24
Enrollment
104
Registered
2026-09-09
Start date
2026-10-01
Completion date
2027-10-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Care After Cardiac Implantable Electronic Device Implantation

Keywords

Cardiac Implantable Electronic Device, CIED, Arm Sling, Pacemaker, Implantable Cardioverter-Defibrillator, Cardiac Resynchronization Therapy, Postoperative Care, Pain, Patient Comfort, Patient Satisfaction, Device-Related Complications

Brief summary

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.

Detailed description

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.

Interventions

DEVICEMedical Arm Sling

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.

Sponsors

Tugba Yorulmaz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor will be blinded to participant group allocation. Participants and care providers cannot be blinded because of the visible nature of the arm sling intervention.

Intervention model description

Participants will be randomized in a 1:1 ratio to either a medical arm sling group or a standard care group and will be followed in parallel.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Comfort Assessed Using the Visual Analog Comfort Scale2, 6, 12, and 24 hours after CIED implantationPatient 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.

Contacts

CONTACTTuğba Yorulmaz, PhD
tugba.yorulmaz@acibadem.edu.tr+90 216 500 4220
CONTACTRabia Muhan Eraslan, MSc
rabia.muhan@acibadem.edu.tr+90 216 500 7707
PRINCIPAL_INVESTIGATORTugba Yorulmaz, PhD

Acibadem University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026