NCT06478095

Brief Summary

This study aims to evaluate the impact of preoperative visual aids on anxiety and pain management in patients with low educational backgrounds undergoing glaucoma filtration surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 8, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

June 24, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

Preoperative visit;glaucoma;filtering surgery

Outcome Measures

Primary Outcomes (1)

  • Anxiety levels, pain scores, blood pressure, and pulse rates

    measured at multiple time points

    1 day prior to surgery; 30 minutes prior to surgery; 5 minutes after the onset of surgery; the conclusion of the surgical procedure

Study Arms (2)

The conventional oral education group

NO INTERVENTION

Patients were only orally educated about glaucoma, preoperative preparation, surgical procedures, anaesthesia methods, and precautions during the preoperative visit.

The Visual aids plus conventional oral education group

EXPERIMENTAL

Patients were orally educated about glaucoma, preoperative preparation, surgical procedures, anaesthesia methods, and precautions with pictures and videos during the preoperative visit.

Behavioral: Visual aids

Interventions

Visual aidsBEHAVIORAL

Diagrams, models, and videos

The Visual aids plus conventional oral education group

Eligibility Criteria

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

You may qualify if:

  • Adult inpatients with age ≥18 years
  • Illiterate or with ≤ 9 years of compulsory education
  • Indications for filtering surgery

You may not qualify if:

  • Mental illness
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

Shantou, Guangdong, 515041, China

Location

MeSH Terms

Interventions

Audiovisual Aids

Intervention Hierarchy (Ancestors)

Educational TechnologyTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Chukai Huang, PhD

    Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
surgeons were blinded to the patient group assignments.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 27, 2024

Study Start

March 8, 2023

Primary Completion

February 21, 2024

Study Completion

March 28, 2024

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

The individual participant data can be requested and accessed by contacting the study management teams of the studies on reasonable request. Such requests are adjudicated on a case-by-case basis. The study protocol and statistical analysis plan will be available and be accessed once the paper is accepted.

Locations