Effectiveness of Multimedia Health Education to Reduce Anxiety in Patients With Vitreous Floaters
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChangzhou No.2 People's Hospital
About this trial
The patients with vitreous floaters were randomly divided into to groups after excluding the possibility of coexisting ocular pathologies potentially confounding visual symptoms or vitreoretinal anatomy. The control group performed conventional oral education. The experimental group conducted multimedia health education activities on the basis of conventional oral education. Their VRQoL (Visual Function Questionnaire-25, VFQ-25) and anxiety status (State-Trait Anxiety Inventory, STAI) were evaluated before education and at the final follow-up. The demographic and clinical characteristics (gender, age, eduaction, duration of vitreous floaters, comorbidities and so on) were collected.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of vitreous floaters;
Be able to complete questionnaires.
Disqualifiers
Secondary VF requiring surgical intervention;
Coexisting ocular pathologies potentially confounding vitreoretinal anatomy;
History of vitreoretinal surgery.
Trial design
Design model
Single group
Treatments tested in this trial
Multimedia Health Education
Other interventionMultimedia health education was designed as an intervention. This intervention was administered by a single vitreoretinal specialist with over a decade of clinical experience. This standardized protocol comprised a 30-minute didactic session utilizing power point presentations (PPT), systematically covering: 1) Etiopathogenesis: Molecular mechanisms of vitreous syneresis and collagen aggregation; 2) Symptomatology: Characteristic visual phenomena and differential diagnosis; 3) Therapeutic modalities: Evidence hierarchy from observation to vitrectomy (including Nd:YAG laser efficacy controversies); 4) Follow-up necessity: Red flag symptoms warranting urgent re-evaluation (sudden floaters with photopsia)
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: the multimedia health education groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
State-Trait Anxiety Inventory scores
This questionnaire comprise two 20-item subscales state anxity and trait anxiety: STAI-state evaluating transient emotional responses ("how you feel right now") and STAI-trait measuring stable anxiety predisposition ("how you generally feel"). The scores for each test ranged from 20 to 80 points, with higher scores indicating higher anxiety.Scoring followed Spielberger's manualized criteria. According to the Spielberger manual, STAI-state and STAI-trait are categorized as follows: mild anxiety ranges from 20 to 39, moderate anxiety from 40 to 59, and high anxiety from 60 to 80.
Time frame
before the intervention, 3months after the interventionSecondary outcomes
1
Visual Function Quality 25 scores.
The scale consists of 12 dimensions empassing 26 items, including one overall health scale and 11 visual related scales. 26 items all scored ranged from 0 to 100 points, The 26 items are scored on a scale from 0 to 100 points. If the patient responds with 1, 2, 3, 4, or 5, the scores are assigned as 0, 25, 50, 75, and 100 points, respectively. A higher scale score indicates better VRQoL, while a lower score reflects poorer visual-related quality of life.
Time frame
before the intervention, 3months after the interventionSponsors and contacts
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Source ClinicalTrials.gov