NCT07408817

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 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 31, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

December 13, 2025

Last Update Submit

February 6, 2026

Conditions

Keywords

cataractanxietyteleconsultation

Outcome Measures

Primary Outcomes (1)

  • Preoperative Anxiety Level

    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 Outcomes (3)

  • Patient 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

    Assessed once at baseline during the preoperative evaluation, within 1-7 days prior to cataract surgery.

  • Adherence to Preoperative Care Instructions

    Assessed once at baseline during the preoperative evaluation, within 1-7 days prior to cataract surgery.

Study Arms (2)

Structured Counseling Provided Via Teleconference Before Cataract Surgery Affects Patient Outcomes.

EXPERIMENTAL

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

Standard Care Group

ACTIVE COMPARATOR

Participants will receive routine preoperative education and standard clinical care before cataract surgery.

Behavioral: Routine Preoperative Education and Standard Clinical Care

Interventions

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.

Structured Counseling Provided Via Teleconference Before Cataract Surgery Affects Patient Outcomes.

Participants will receive routine preoperative education and standard clinical care according to institutional protocols. No additional educational or counseling intervention will be provided.

Standard Care Group

Eligibility Criteria

AgeUp to 80 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın Üniversitesi

Bartın, Turkey (Türkiye)

Location

MeSH Terms

Conditions

CataractAnxiety Disorders

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
graduate student

Study Record Dates

First Submitted

December 13, 2025

First Posted

February 13, 2026

Study Start

January 31, 2025

Primary Completion

May 21, 2025

Study Completion

May 31, 2025

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations