NCT07030946

Brief Summary

This study aims to examine the effectiveness of multimedia health education in reducing preoperative anxiety and enhancing self-care awareness among patients undergoing outpatient cataract surgery. A randomized group design will be employed, in which participants will receive either standard preoperative education or a multimedia-based intervention covering surgical procedures, precautions, and postoperative care. Primary outcomes include levels of surgical anxiety, assessed using validated anxiety scales, and self-care knowledge evaluated through structured questionnaires. Findings are expected to inform the development of patient-centered educational strategies and enhance perioperative care quality in cataract surgery settings.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Aug 2025Mar 2027

First Submitted

Initial submission to the registry

June 3, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 4, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

January 8, 2026

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

June 3, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

Self-Care AwarenessMultimedia Health EducationCataract SurgeryPreoperative AnxietyPatient Education as TopicNursing InterventionRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Change in anxiety levels measured by the Beck Anxiety Inventory (BAI)

    Participants will complete the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire used to assess the severity of anxiety symptoms. The total score ranges from 0 to 63, with higher scores indicating greater levels of anxiety. Specifically, scores from 0-7 suggest minimal anxiety, 8-15 mild anxiety, 16-25 moderate anxiety, and 26-63 severe anxiety. The BAI will be administered at baseline and at three follow-up points.

    Time Frame: Day 0 (baseline, preoperative clinic visit), Day of Surgery, 1 Week Postoperative, 1 Month Postoperative

  • Change in self-care knowledge related to cataract surgery

    Participants will complete a structured questionnaire designed to evaluate their knowledge of postoperative cataract care. Scores will be compared across time points to determine the impact of multimedia education.

    Time Frame: Day 0 (baseline, preoperative clinic visit), Day of Surgery, 1 Week Postoperative, 1 Month Postoperative

Secondary Outcomes (3)

  • Change in heart rate

    Time Frame: Day 0 (baseline, preoperative clinic visit), Day of Surgery

  • Change in visual acuity following cataract surgery

    Time Frame: Day 0 (baseline, preoperative clinic visit), 1 Week Postoperative, 1 Month Postoperative

  • Change in blood pressure

    Day 0 (baseline, preoperative clinic visit), Day of Surgery

Study Arms (2)

Control Group

NO INTERVENTION

Participants in the control group will receive standard preoperative education, including verbal explanation and printed materials about cataract surgery and postoperative care, provided by the ophthalmologist during the final clinic visit before surgery.

Multimedia Education Group

EXPERIMENTAL

Participants in the multimedia education group will receive the same standard preoperative education as the control group, plus a 10-minute multimedia video covering the surgical procedure, preoperative instructions, postoperative care guidelines, and common patient concerns. The video includes both visual animations and spoken explanations.

Behavioral: Multimedia Health Education

Interventions

A 10-minute multimedia video is provided to the intervention group during their final preoperative clinic visit. All participants receive standard verbal and printed education from the ophthalmologist. The video includes visual and auditory content on cataract surgery, preoperative instructions, postoperative care, and common concerns. Baseline data (T0) are collected before the intervention, including demographics, visual acuity, physiological indicators, BAI, and self-care knowledge. Follow-ups occur at T1 (surgery day), T2 (1 week postop), and T3 (1 month postop), assessing anxiety, physiology, vision, and self-care.

Multimedia Education Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Diagnosed with cataract and scheduled for elective phacoemulsification with intraocular lens implantation (first-time surgery)
  • Able to communicate in Mandarin or Taiwanese
  • Blood glucose \<250 mg/dL and HbA1c \<8% if diabetic (assessed by attending physician)

You may not qualify if:

  • Diagnosed with dementia or psychiatric disorders
  • History of previous cataract surgery
  • Severe hearing impairment (certified disability without hearing aid)
  • Systolic blood pressure \>160 mmHg on the day of surgery
  • Preoperative visual acuity less than 0.05
  • Undergoing combined ocular procedures (e.g., vitrectomy) during cataract surgery
  • Unable to use digital devices required for the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keelung Chang Gung Memorial Hospital, Operating Room

Keelung, Keelung, 204, Taiwan

RECRUITING

Related Publications (2)

  • Yu X, Vargas J, Green PHR, Bhagat G. Innate Lymphoid Cells and Celiac Disease: Current Perspective. Cell Mol Gastroenterol Hepatol. 2021;11(3):803-814. doi: 10.1016/j.jcmgh.2020.12.002. Epub 2020 Dec 10.

    PMID: 33309944BACKGROUND
  • Jafarzadeh M, Saatchi M, Jafarnejadi P, Gooran M. Digital Radiographic Evaluation of the Quality of Different Root Canal Obturation Techniques in Deciduous Mandibular Molars after Preparation with Rotary Technique. J Dent (Shiraz). 2019 Sep;20(3):152-158. doi: 10.30476/DENTJODS.2019.44902.

    PMID: 31579688BACKGROUND

MeSH Terms

Conditions

CataractAnxiety Disorders

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesMental Disorders

Central Study Contacts

Tsen-Yu Tu, RN, BSN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study adopts a randomized experimental research design with two-group repeated measures. A single-blind procedure is implemented, in which patients are blinded to group allocation (patient blinding).
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two-arm parallel group trial comparing standard education vs. multimedia education
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 22, 2025

Study Start

August 4, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

January 8, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations