Patient Education and Sling Use After Shoulder Surgery
Evaluation of Educational Pamphlets and Female Patient Experience With Post-operative Sling-Wear
This study will evaluate whether educational pamphlets can help patients safely manage personal hygiene, household activities, and female-specific self-care while wearing a sling after surgery. The study will also examine whether following sling-use instructions is associated with better short-term recovery and patient-reported outcomes for up to 6 months after surgery.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Rothman Orthopaedic Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants scheduled to undergo shoulder surgery at Rothman Orthopaedics that requires more than 1 week of postoperative shoulder sling use.
- Participants who are able to provide informed consent.
- Participants who have sufficient English-language proficiency to understand the study materials and complete the study questionnaires.
Exclusion Criteria:
- Participants undergoing shoulder surgery that does not require more than 1 week of postoperative shoulder sling use.
- Participants who do not have sufficient English-language proficiency to understand the study materials and complete the study questionnaires.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group - Standard postoperative education
Standard postoperative education |
Participants will receive the standard postoperative education and instructions provided by their treating orthopedic physician for patients undergoing shoulder surgery requiring postoperative sling use. |
|
Active Comparator: Pamphlet Intervention Group
Standard postoperative education + "Living with a Sling" educational pamphlets |
Participants will receive standard postoperative education plus educational pamphlets providing guidance on performing daily activities while wearing a shoulder sling. The pamphlets address personal hygiene, household tasks, and self-care. Female participants will also receive a pamphlet addressing female-specific self-care. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sling adherence
Time Frame: 4 to 6 weeks after surgery
|
Sling adherence will be assessed using patient-reported survey responses regarding adherence to prescribed shoulder sling use during the postoperative period. |
4 to 6 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-reported shoulder function
Time Frame: 6 months after surgery
|
Shoulder function will be assessed using the American Shoulder and Elbow Surgeons (ASES) score. |
6 months after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-reported shoulder status
Time Frame: 6 months after surgery
|
Patient-reported shoulder status will be assessed using the Single Assessment Numeric Evaluation (SANE). |
6 months after surgery
|
|
Patient experience while wearing a shoulder sling
Time Frame: 6 weeks after surgery
|
Participants will complete a questionnaire assessing their experience performing daily activities, including personal hygiene, household tasks, and self-care while wearing a shoulder sling. |
6 weeks after surgery
|
|
Preparedness for postoperative activities
Time Frame: 6 weeks after surgery
|
Participants will report their preparedness and ability to manage daily activities while wearing a shoulder sling. |
6 weeks after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBIS2024-1306
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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