Effectiveness of Multimedia Health Education to Reduce Anxiety in Patients With Vitreous Floaters

May 10, 2025 updated by: Qing Feng, Changzhou No.2 People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients inclusion criteria: 1)Patients with VF visited the Department of Ophthalmology, the third affiliated hospital of Nanjing Medical University between December 2023 and April 2025; 2) Endogenously derived subjective floaters confirmed by comprehensive ophthalmic examination including slit-lamp biomicroscopy, dilated fundoscopy, optical coherence tomography (OCT) and so on; 3) Willing to participate in the multimedia health education program and complete validated questionnaires, with written informed consent obtained.

exclusion criteria:

1)Secondary VF requiring surgical intervention (e.g., vitreous hemorrhage, retinal breaks, or uveitis); 2) Coexisting ocular pathologies potentially confounding visual symptoms or vitreoretinal anatomy (e.g., diabetic retinopathy, retinal vascular occlusion, epiretinal membrane, or vitreomacular traction syndrome); 3) History of vitreoretinal surgery (PPV or laser procedures); 4) Refusal or inability to complete study protocols.

Intervention:

Multimedia 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). Multimedia presentation was made through pictures, texts, sounds, and videos. The simple and easy-to-understand language were used to make population easy to accept.

All participants underwent comprehensive ophthalmic evaluations comprising best-corrected visual acuity (BCVA), slit-lamp biomicroscopy with anterior segment analysis, dilated fundus examination incorporating scanning laser ophthalmoscopy (SLO) and spectral-domain optical coherence tomography (SD-OCT) to exclude vitreoretinal interface pathologies such as epiretinal membranes, macular holes and so on. Demographic and clinical baseline characteristics were systematically recorded, including gender, age, educational attainment, sympotom duration, presence or absence of photopsia, time of using electronic products daily, comorbidities, shape of floaters, diopter, psychometric and visual-related quality of life (VRQoL) assessments using National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and State-Trait Anxiety Inventory (STAI). To minimize intervention selection bias, a pragmatic temporal allocation protocol was implemented: Patients attending the clinic during odd-numbered calendar weeks were prospectively allocated to the multimedia health education group whereas those presenting during even-numbered weeks comprised the routine verbal group.

At the 3-month follow-up, both groups completed validated the VFQ-25 and STAI-state questionnaires via phone or wechat.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213100
        • Recruiting
        • The Second People's Hospital of Changzhou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Clinical diagnosis of vitreous floaters;
  2. Be able to complete questionnaires.

Exclusion Criteria:

  1. Secondary VF requiring surgical intervention;
  2. Coexisting ocular pathologies potentially confounding vitreoretinal anatomy;
  3. History of vitreoretinal surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the multimedia health education group
Multimedia 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)
Other: Multimedia Health Education
Multimedia 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory scores
Time Frame: before the intervention, 3months after the intervention
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.
before the intervention, 3months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Function Quality 25 scores.
Time Frame: before the intervention, 3months after the intervention
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.
before the intervention, 3months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changzhou No.2 People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 10, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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