NCT06555770

Brief Summary

Cataract is one of the leading causes of preventable blindness in the world and in Türkiye. Cataract surgery is one of the most frequently performed and most reliable surgeries for eye diseases. Advances in anesthesia and surgical techniques make it possible for most cataract surgery procedures to be performed under topical anesthetic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

August 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

August 13, 2024

Last Update Submit

April 23, 2025

Conditions

CataractNursing Caries

Keywords

cataractmusic interventionstress ballpainanxiety

Outcome Measures

Primary Outcomes (7)

  • Pain (Visual Analog Scale)

    Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.

    15 minutes before surgery

  • Pain (Visual Analog Scale)

    Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.

    During surgery

  • Pain (Visual Analog Scale)

    Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.

    10 minutes after surgery

  • Anxiety (Visual Analog Scale-Anxiety)

    Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.

    15 minutes before surgery

  • Anxiety (Visual Analog Scale-Anxiety)

    Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.

    During surgery

  • Anxiety (Visual Analog Scale-Anxiety)

    Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.

    10 minutes after surgery

  • State-Trait Anxiety Inventory (STAI-II)

    STAI-II is a well-researched clinical tool for evaluating the tendency towards anxiety. A cut-off point of 39-40 typically indicates clinically significant symptoms of a state of anxiety.

    15 minutes before surgery

Study Arms (3)

Stres topu grubu

EXPERIMENTAL

Pain levels will be tested with VAS 10 minutes before the surgery, and anxiety levels with the VAS-A and Spielberg Continuous Anxiety Scale. The stress balls will be given to both hands of the patient, counting to five and pressing twice. The patient will be shown to use the stress balls for 15 minutes during the surgery. The patient will be told to use the stress balls for 15 minutes during the surgery. After 15 minutes, the researcher will inform the patient and make sure the patient drops the balls.

Behavioral: müzik müdahalesi

Müzik grubu

EXPERIMENTAL

Pain levels will be tested with VAS 10 minutes before the surgery, and anxiety levels with the VAS-A and Spielberg Continuous Anxiety Scale. According to the randomization, the patient in the music intervention group will first be asked by the researcher to select his favorite music from the playlist. The playlist will be created using the Spotify app. The playlist will include a total of 50 songs from each group (pop, Turkish art music, local Turkish and religious music), including ten songs. Options will be shown to the patient on the phone (Apple/MU783TU/A) and the music he wants will be added to the playlist. The patient will be told that the selected music will be listened to for 15 minutes during cataract surgery.

Behavioral: müzik müdahalesi

Kontrol grubu

NO INTERVENTION

Pain levels will be tested with VAS 10 minutes before the surgery, and anxiety levels with the VAS-A and Spielberg Continuous Anxiety Scale. The patient in the control group will not be given any intervention.

Interventions

müzik müdahalesiBEHAVIORAL

One group of patients will be listening to music for 15 minutes during the surgery, while the other group will be applied a stress ball.

Also known as: stres topu
Müzik grubuStres topu grubu

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older and undergoing PHACO surgery,
  • Not having any hearing or perception problems,
  • Not having any physical problems to squeeze a stress ball,
  • Having undergone cataract surgery for the first time,
  • Being willing to participate in the research.

You may not qualify if:

  • Any use of any analgesic or anxiolytic within 24 hours prior to surgery,
  • Transition from topical to general anesthesia during surgery,
  • A psychiatric diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seda Cansu Yeniğün

Antalya, Kumluca, 07350, Turkey (Türkiye)

Location

MeSH Terms

Conditions

CataractPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Dr

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 15, 2024

Study Start

August 20, 2024

Primary Completion

February 20, 2025

Study Completion

March 1, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Locations

TU(1)