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Comparative Study of Psychology and Glaucoma Knowledge in Glaucoma Day-ward Patients Inpatients

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03125850
Collaborator
(none)
240
Enrollment
1
Location
2
Arms
5
Actual Duration (Months)
47.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will compare the glaucoma day-ward patients' efficacy with inpatients by evaluating the glaucoma knowledge and psychology , and will analysis the reasons of the differences. Half of participants will receive treatment in day-ward, while the other half will receive treatment in hospital.

Condition or Disease Intervention/Treatment Phase
  • Other: randomized to day ward
  • Other: randomized to inpaitent
 N/A

Detailed Description

Ophthalmic surgery has short operative time, quick recovery, and small anesthesia risk, making day case surgery the main management mode of ophthalmic surgery. This study will explore the differences of psychology and glaucoma knowledge between glaucoma day-ward patients and the inpatients. The data will be collected by scale on admission and discharge.

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Comparative Study of Psychology and Glaucoma Knowledge in Glaucoma Day-ward Patients Inpatients
Actual Study Start Date :
Aug 10, 2017
Actual Primary Completion Date :
Dec 10, 2017
Actual Study Completion Date :
Jan 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: day-ward group

Other: randomized to day ward
Participants will be randomized to day-ward group, and will accept routine treatment, care, centralized education of glaucoma knowledge
Active Comparator: inpatient group

Other: randomized to inpaitent
Participants will be randomized to day-ward group, and will accept routine treatment, care, centralized education of glaucoma knowledge

Outcome Measures

Primary Outcome Measures

  1. Change of depression and anxiety score [at baseline and 1 hour before discharge]

    The outcome will be measured by The Hospital Depression and Anxiety Scale (HADS). It consists of two subscales: HDAS-anxiety and HADS-depression. Each item is srored from 0-3, with higher scores indicating a higher level of depression and anxiety. For each of the seven-item subscales, the minimum sum score is 0, and the maximum is 21.

  2. Change of glaucoma knowledge score [at baseline and 1 hour before discharge]

    The outcome will be measured by The Gray Glaucoma Knowledge Questionaire. This quesionanire has a total maximum score of 17, with higher scores representing better knowledge.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Patient is diagnosed with glaucoma;

  2. Will receive glaucoma surgery;

  3. Voluntary participation in this study;

  4. Have enough language comprehension ability;

  5. Best corrected visual acuity reach 0.1 or better;

  6. Patient or his legal representative has sign the informed consent.

Exclusion Criteria:

  1. Patient with mental disorder;

  2. There are important viscera function failure or other serious disease, including clinical related coronary artery disease, cardiovascular disease or myocardial infarction into the group of the first six months; serious neurological or psychiatric illness; serious infections; coagulant function abnormality; general active infectious diseases; malignant tumor; serious immune diseases;

  3. Patient with monocular blindness;

  4. Axial length≤20 mm;

  5. With other serious eye diseases;

  6. Neurologic diseases that could affect the visual field;

  7. 3 months prior to research to participate in any clinical study;

  8. Researchers think not suitable to participate in this clinical trial subjects;

  9. Refused to sign the informed consent.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center, Sun Yat-San Univerdity Guangzhou Guangdong China

Sponsors and Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Study Chair: Mingkai Lin, MD, Zhongshan Ophthalmic Center, Sun Yat-San University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mingkai Lin, chief physician, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT03125850
Other Study ID Numbers:
  • Zhongshan OC
First Posted:
Apr 24, 2017
Last Update Posted:
Jul 23, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mingkai Lin, chief physician, Zhongshan Ophthalmic Center, Sun Yat-sen University
knowledge
psychology
Additional relevant MeSH terms:
Glaucoma

Study Results

No Results Posted as of Jul 23, 2020