An interventional study of Medical Arm Sling in Postoperative Care After Cardiac Implantable Electronic Device Implantation, sponsored by Tugba Yorulmaz. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Tugba Yorulmaz · Not applicable, Interventional, and Supportive care
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 104 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →This is the only study on the registry with Tugba Yorulmaz as lead sponsor.
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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 .
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Medical Arm Sling
Participants will receive standard postoperative care without the use of a medical 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.
Patient Comfort Assessed Using the Visual Analog Comfort Scale
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.
Time frame: 2, 6, 12, and 24 hours after CIED implantation
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared due to participant confidentiality, privacy, and ethical considerations. Study findings will be reported in aggregate form.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 12 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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