- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07408817
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
Completed
Conditions
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
Interventional
Enrollment (Actual)
128
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
-
-
-
Bartın, Turkey (Türkiye)
- Bartın Üniversitesi
-
-
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
- 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 |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
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
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
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
Collaborators
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)
January 31, 2025
Primary Completion (Actual)
May 21, 2025
Study Completion (Actual)
May 31, 2025
Study Registration Dates
First Submitted
December 13, 2025
First Submitted That Met QC Criteria
February 6, 2026
First Posted (Actual)
February 13, 2026
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 6, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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