Age Related Macular Degeneration, Choroidal Neovascularization, Cystoid Macular Edema, Diabetic Retinopathy, Retinal Vein Occlusion
Conditions
Brief summary
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 1. Can viewing the procedural video prior to treatment reduce the rate and/or area of subconjunctival hemorrhage? 2. Can the video improve the patient experience, specifically by reducing anxiety levels and increasing satisfaction with the treatment process? 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.
Interventions
BEHAVIORALProcedure video viewing
Patients who have never had an intravitreal injection before will be randomly assigned to watch an educational video about the procedure prior to treatment.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are receiving their first intravitreal injection of anti-VEGF medication due to retinal diseases * Mentally competent, and able to communicate without barriers * Willing to voluntarily sign an informed consent form.
Exclusion criteria
* History of previous eye surgery * Best-corrected visual acuity in the better eye worse than 0.3 * The target eye is complicated with neovascular glaucoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate and area of subconjunctival hemorrhage | 3 minutes after the intravitreal injection procedure. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety levels assessed by State-Trait Anxiety Inventory-State (STAI-S) | 30 minutes before and after the procedure. | State-Trait Anxiety Inventory-State (STAI-S) questionnaire both before and after treatment to assess changes in anxiety levels |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction assessed by a satisfaction score questionnaire | 30 minutes after the procedure. | 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. |
| Physician's assessment of patient cooperation during the procedure | Immediately after the intravitreal injection 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. |
| Total procedure time | During the procedure. | The time duration from the start of disinfection to the completion of the injection. |
Countries
China
Contacts
Primary ContactXiaoyun Fang, MD., PhD.
Backup ContactFang Zheng, MD., PhD
Outcome results
None listed