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Study Objective The goal of this clinical trial is to evaluate whether viewing a procedural video can improve the patient experience and reduce the incidence and severity of subconjunctival hemorrhage in individuals undergoing intravitreal anti-VEGF injections.
Key Research Questions
Study Design Participants will be randomly assigned to either an intervention group, who will watch an educational video explaining the injection procedure, or a control group, who will not view the video.
All participants will complete the State-Trait Anxiety Inventory-State (STAI-S) questionnaire both before and after treatment to assess changes in anxiety levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedural video viewing Group | Experimental | Participants will watch an educational video explaining the injection procedure prior to treatment. |
|
| Control Group | No Intervention | Participants will not view the video before the treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure video viewing | Behavioral | Patients who have never had an intravitreal injection before will be randomly assigned to watch an educational video about the procedure prior to treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate and area of subconjunctival hemorrhage | After the injection, a photograph of the eye will be taken to document the presence of subconjunctival hemorrhage and to measure the hemorrhage area using ImageJ software. | 3 minutes after the intravitreal injection procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety levels assessed by State-Trait Anxiety Inventory-State (STAI-S) | State-Trait Anxiety Inventory-State (STAI-S) questionnaire both before and after treatment to assess changes in anxiety levels | 30 minutes before and after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction assessed by a satisfaction score questionnaire | Patient satisfaction with the treatment process will be assessed using a 10-point Likert scale satisfaction score collected after the procedure, where 1 indicates "not satisfied at all" and 10 indicates "completely satisfied". | 30 minutes after the procedure. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyun Fang, MD., PhD. | Contact | + 86 13588411946 | xiaoyunfang@zju.edu.cn | |
| Fang Zheng, MD., PhD | Contact | +86 18258499106 | zhengfanggo@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyun Fang, MD., PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31305506 | Background | Yahalomi T, Hecht I, Lagstein O, Nemet A, Pe'er L, Hadad F, Keren-Yaar A, Kassem R, Burgansky-Eliash Z, Bar A, Achiron A. REDUCTION OF POSTINTRAVITREAL INJECTION PAIN USING ICE: An Open-Label Interventional Randomized Controlled Trial. Retina. 2020 Jul;40(7):1434-1438. doi: 10.1097/IAE.0000000000002608. | |
| 28064517 | Background |
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Only IPD used in the results publication.
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D003930 | Diabetic Retinopathy |
| D020256 | Choroidal Neovascularization |
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
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| Physician's assessment of patient cooperation during the procedure |
Physician's assessment of patient cooperation during the procedure Patient cooperation will be assessed by the physician immediately after the procedure using a 10-point Likert scale, where 1 indicates completely uncooperative and 10 indicates fully cooperative. The scale is based on observable patient behavior such as adherence to instructions, physical movements, and verbal interaction during the procedure. |
| Immediately after the intravitreal injection procedure |
| Total procedure time | The time duration from the start of disinfection to the completion of the injection. | During the procedure. |
| Boyle J, Vukicevic M, Koklanis K, Itsiopoulos C, Rees G. Experiences of patients undergoing repeated intravitreal anti-vascular endothelial growth factor injections for neovascular age-related macular degeneration. Psychol Health Med. 2018 Feb;23(2):127-140. doi: 10.1080/13548506.2016.1274040. Epub 2017 Jan 9. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |