NCT05943184

Brief Summary

Materials and Methods

  1. 1.General information This study enrolled 153 patients with congenital glaucoma who were treated at our hospital from January 2021 to December 2022. These patients were divided into an observation group (n = 76) and a control group (n = 77) using a random number table. The inclusion criteria were as follows: (1) meeting the diagnostic criteria for glaucoma, (2) following the attending doctor's recommendations to receive surgical treatment, and (3) volunteering to participate in the study. The exclusion criteria were as follows: (1) severe organic dysfunction, (2) cardiovascular and/or cerebrovascular diseases, (3) hypertension, (4) contraindications for surgery, (5) other eye diseases, (6) communication disorders, and (7) mental illnesses. Informed consent with signature was obtained from every participant, and the study has been approved by the hospital's ethics committee.
  2. 2.Research methods The control group was provided with routine care, including warm reception and provision of a quiet, clean, and well-ventilated ward environment for good rest. Patients were educated to broaden their knowledge of the disease and related surgical treatment, particularly the importance and outcomes of surgical treatment, thereby allaying their feeling of fear and boosting their confidence in recovery. Meanwhile, patients were encouraged to break their unhealthy habits, avoid bad diet choices, and take medications on time.
  3. 3.Statistical analysis The software SPSS22.0 was used for data analysis. Measurement data were expressed as "mean ± standard deviation (x±s)", and comparisons between the two groups were examined by the t-test. Enumeration data were represented as percentages (%) and inter-group comparisons were examined using the χ2 test. Significance was set at the level of P \<0.05.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

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

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

June 14, 2023

Last Update Submit

April 22, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • SDS scores

    The cutoff score for SAS is 50, with scores of 50-59 indicative of mild anxiety, 60-69 of moderate anxiety, and scores above 70 of severe anxiety.

    before and at one month of nursing intervention

  • SAS scores

    The cutoff score for SDS is 53, with scores of 53-62 standing for mild depression, 63-72 for moderate depression, and scores above 72 for severe depression.

    before and at one month of nursing intervention

  • Psychological resilience

    The level of psychological resilience was evaluated using the Connor-Davidson Resilience Scale, which covers three dimensions: optimism, self-efficacy, and resilience, with the total score ranging from 0 to 100, and higher scores reflecting greater resilience.

    Baseline (Before the intervention)

  • Patient compliance

    The level of patient compliance during the perioperative period was assessed using an evaluation form that describes the level of compliance as complete compliance (compliance with all medical orders, surgical procedures, dietary guidelines, and schedule), partial compliance (occasional compliance with all medical orders, surgical procedures, dietary guidelines, and schedule), or noncompliance (failure to meet any of the above-mentioned criteria). The compliance rate (%) was calculated as (complete compliance + partial compliance) / total cases × 100%.

    Immediately after nursing

  • Visual acuity (VA)

    a higher VA value indicates better treatment outcomes

    At 2 weeks of nursing intervention

  • IOP

    a lower IOP values indicates better treatment outcomes

    At 2 weeks of nursing intervention

  • mean deviation (MD)

    a lower MD values indicates better treatment outcomes

    At 2 weeks of nursing intervention

Study Arms (2)

Control group

NO INTERVENTION

Observation group

EXPERIMENTAL
Behavioral: Cognitive Behavioral Nursing Model

Interventions

(1)Psychological intervention was accessible to those who felt resistant to their treatment plans or developed inferior feelings due to visual impairment to establish a good relationship with patients and help them better cope with unhealthy emotions. (2) Health education was provided through self-developed booklets and question-and-answer sessions to publicize the fundamental knowledge and make sure all patients have a full understanding of the disease and related treatments. (3) Dietary guidelines were set out to encourage a light, healthy diet with fruits and vegetables, free of irritating food, and containing a limited amount of oily food. (4) Behavioral guidelines were developed to address the importance of quitting tobacco use and prevent eye strain due to excessive eye use with tailored eye care plans.

Observation group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • meeting the diagnostic criteria for glaucoma;
  • following the attending doctor's recommendations to receive surgical treatment, and;
  • volunteering to participate in the study

You may not qualify if:

  • severe organic dysfunction;
  • cardiovascular and/or cerebrovascular diseases;
  • hypertension;
  • contraindications for surgery;
  • other eye diseases;
  • communication disorders;
  • mental illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiyuan Central hospital of Shanxi Medical University

Taiyuan, Shanxi, 030009, China

Location

MeSH Terms

Conditions

Hydrophthalmos

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesGlaucoma, Open-AngleGlaucomaOcular HypertensionCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 13, 2023

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations