Teleconference-Based Structed Counseling (CAT-TELE)

February 6, 2026 updated by: Mehtap ÖZTÜRK BAKIR

The Effect of Structured Counseling Provided Via Teleconference Before Cataract Surgery on Patient Outcomes and Anxiety

This study is a randomized controlled trial designed to evaluate the effect of structured teleconference-based counseling provided before cataract surgery on patients' anxiety levels and predefined postoperative outcome measures. The study will be conducted between January 31, 2025, and May 31, 2025, at a public hospital located in the Western Black Sea Region. The study population will consist of patients scheduled for cataract surgery. Eligible participants will be assigned to the intervention or control group using a simple random sampling method. Patients in the intervention group will receive structured teleconference-based counseling prior to surgery, while patients in the control group will receive standard preoperative care. Data will be collected using the Patient Information Form, the State-Trait Anxiety Inventory, the Tele-Nursing Evaluation Form, and the Patient Outcome Form. Participants will be followed up by telephone on postoperative days 1, 3, and 7. Statistical analyses of the collected data will be performed using SPSS version 29.0.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomized controlled study is planned to examine the effect of structured teleconference-based counseling provided before cataract surgery on patients' anxiety levels and predefined postoperative variables. The study will be carried out with patients scheduled for cataract surgery at a public hospital in the Western Black Sea Region. Eligible participants will be randomly assigned to either the intervention group or the control group. Patients in the intervention group will receive structured counseling via teleconference prior to surgery, while those in the control group will receive routine preoperative care. Data will be collected using validated data collection tools, including the Patient Information Form, the State-Trait Anxiety Inventory, the Tele-Nursing Evaluation Form, and the Patient Outcome Form. Anxiety levels and postoperative variables will be assessed at predetermined time points, including preoperative assessment and postoperative follow-up on days 1, 3, and 7. This study aims to contribute to the development of evidence-based nursing practices by evaluating the role of teleconference-based preoperative counseling.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Criteria for inclusion in the study:
  • The patient must be willing to participate in the study
  • There must be no impediments to communication
  • Willingness to cooperate
  • Being 18 years of age or older
  • No diagnosed mental illness
  • Being able to read and write
  • Being able to communicate by telephone
  • Using a smartphone and having an internet connection

Exclusion criteria:

  • Not wanting to participate in the study
  • Having previously undergone eye surgery
  • Having a communication barrier
  • Not being open to cooperation
  • Being under 18 years of age
  • Having a diagnosed mental illness
  • Being illiterate
  • Being unable to use communication tools
  • Not having a smartphone and internet connection

Translated with DeepL.com (free version)

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Structured Counseling Provided Via Teleconference Before Cataract Surgery Affects Patient Outcomes.
participants will receive structured preoperative counselling via teleconference before cataract surgery in addition to standard care
Behavioral: Teleconference-Based Structured Preoperative Counseling Program for Cataract Surgery
Participants will receive a structured, standardized preoperative counseling program delivered via teleconference in addition to standard care. The intervention will be conducted 1-3 days before cataract surgery as a single session lasting approximately 30-40 minutes and will be delivered by a trained nurse/researcher.
Active Comparator: Standard Care Group
Participants will receive routine preoperative education and standard clinical care before cataract surgery.
Behavioral: Routine Preoperative Education and Standard Clinical Care
Participants will receive routine preoperative education and standard clinical care according to institutional protocols. No additional educational or counseling intervention will be provided.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preoperative Anxiety Level
Time Frame: Assessed once at baseline during the preoperative evaluation, within 1-7 days prior to cataract surgery.

Preoperative anxiety level will be assessed using the State-Trait Anxiety Inventory (STAI).

The STAI consists of two 20-item subscales: State Anxiety and Trait Anxiety. Each subscale has a total score range of 20 to 80. Higher scores indicate higher levels of anxiety, representing a worse outcome.
Assessed once at baseline during the preoperative evaluation, within 1-7 days prior to cataract surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Knowledge About Cataract Surgery
Time Frame: Assessed once at baseline during the preoperative evaluation, within 1-7 days prior to cataract surgery.
Patient knowledge level will be assessed using a structured Patient Knowledge Questionnaire developed for cataract surgery education. Total scores range from 0 to 100, with higher scores indicating greater knowledge about cataract surgery.
Assessed once at baseline during the preoperative evaluation, within 1-7 days prior to cataract surgery.
Patient Satisfaction With Preoperative Information
Time Frame: Assessed once at baseline during the preoperative evaluation, within 1-7 days prior to cataract surgery.
Patient satisfaction with preoperative information will be assessed using a structured Patient Satisfaction Questionnaire related to preoperative education. Total scores range from 0 to 100, with higher scores indicating higher patient satisfaction.
Assessed once at baseline during the preoperative evaluation, within 1-7 days prior to cataract surgery.
Adherence to Preoperative Care Instructions
Time Frame: Assessed once at baseline during the preoperative evaluation, within 1-7 days prior to cataract surgery.
Adherence to preoperative care instructions assessed using a checklist-based evaluation form.
Assessed once at baseline during the preoperative evaluation, within 1-7 days prior to cataract surgery.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mehtap ÖZTÜRK BAKIR

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bartin State Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BU-Cataract-Tele-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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