Postoperative Care After Cardiac Implantable Electronic Device ImplantationCIED-SLING24NCT07810426
Effects of Short-Term Arm Sling Use After Cardiac Implantable Electronic Device Placement
A study testing Medical Arm Sling in people with Postoperative Care After Cardiac Implantable Electronic Device Implantation, run by Tugba Yorulmaz.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Care After Cardiac Implantable Electronic Device Implantation
- What is being tested?
- Medical Arm Sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Medical Arm Sling
- 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
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Arm SlingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical Arm Sling Group | Experimental | 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. Receives: Device: Medical Arm Sling |
| Standard Care Group | No intervention | Participants will receive standard postoperative care without the use of a medical arm sling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2, 6, 12, and 24 hours after CIED implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Care After Cardiac Implantable Electronic Device ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tugba Yorulmaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tugba Yorulmaz, Acibadem University
- Investigators
- Tugba Yorulmaz, PhD, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810426
- Sponsor's protocol ID
- 2026-13/631
- Acronym
- CIED-SLING24
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07810426
- Acronym / sponsor ID
- CIED-SLING24 / 2026-13/631
- Keywords
- Cardiac Implantable Electronic Device, CIED, Arm Sling, Pacemaker, Implantable Cardioverter-Defibrillator, Cardiac Resynchronization Therapy, Postoperative Care, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Tugba YorulmazUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medical Arm Sling Group | Experimental | Device: Medical Arm SlingParticipants will receive standard postoperative care and will use a medical arm sling on the side of CIED implantation for 24 hours after the procedure. |
| Standard Care Group | No intervention | –Participants will receive standard postoperative care without the use of a medical arm sling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Arm SlingA 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. | Device | Medical Arm Sling Group |
Primary outcome
Patient Comfort Assessed Using the Visual Analog Comfort Scale
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tugba Yorulmaz, PhD principal investigator
Acibadem University
Questions about this trial
What is this clinical trial studying?
A study testing Medical Arm Sling in people with Postoperative Care After Cardiac Implantable Electronic Device Implantation, run by Tugba Yorulmaz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba Yorulmaz, PhD (+90 216 500 4220 ext. 4220, tugba.yorulmaz@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Comfort Assessed Using the Visual Analog Comfort Scale (time frame: 2, 6, 12, and 24 hours after CIED implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.