Preoperative Visual Aids on Glaucoma Surgical Patients

June 26, 2024 updated by: Laiwen Lv, Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

Preoperative Visual Aids on Patients With Low Educational Backgrounds Undergoing Glaucoma Filtration Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, single-blinded, single-centre clinical trial was conducted at a tertiary eye hospital in Shantou, China. Patients scheduled for glaucoma filtration surgery were randomly assigned to either a conventional oral education group or a visual aids group. Anxiety levels, pain scores, blood pressure, and pulse rates were measured at multiple time points.

Study Type

Interventional

Enrollment (Actual)

133

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 Locations

  • China
    • Guangdong
      • Shantou, Guangdong, China, 515041
        • Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Mental illness
  • Cognitive impairment

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: The conventional oral education group
Patients were only orally educated about glaucoma, preoperative preparation, surgical procedures, anaesthesia methods, and precautions during the preoperative visit.
Experimental: The Visual aids plus conventional oral education group
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
Diagrams, models, and videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety levels, pain scores, blood pressure, and pulse rates
Time Frame: 1 day prior to surgery; 30 minutes prior to surgery; 5 minutes after the onset of surgery; the conclusion of the surgical procedure
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

Collaborators and Investigators

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

Sponsor

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

Collaborators

Shantou University Medical Colleage

Investigators

  • Study Director: Chukai Huang, PhD, Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

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)

March 8, 2023

Primary Completion (Actual)

February 21, 2024

Study Completion (Actual)

March 28, 2024

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC 20220505(4)-P30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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