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NOT YET RECRUITING
NCT06986408
NA

Effect of Earplugs and Eye Masks Used After Orthopedic Surgery on Comfort and Quality of Recovery

Sponsor: Ankara Yildirim Beyazıt University

View on ClinicalTrials.gov

Summary

This research will be conducted as a randomized controlled trial to determine the effects of earplugs and eye masks used after orthopedic surgery on comfort and quality of recovery. This study is a single-center, parallel-group, open-label, randomized controlled clinical trial. This study will be conducted with 60 patients who underwent orthopedic surgery between June 2025 and October 2025. Participants will be randomized into two equal groups as the intervention group (n=30) and the control group (n=30). The patients in the experimental group will be administered the "Informed Consent Form" and the "Patient Introduction Form" after obtaining permission before surgery. Patients will be given an eye mask and earplugs on the nights following surgery and will be ensured to use them correctly. The "General Comfort Scale" and the "Quality of Recovery Questionnaire (Qor-40)" will be administered 24 and 48 hours after surgery. The patients in the control group will also be administered the "Informed Consent Form" and the "Patient Introduction Form" after obtaining permission before surgery. The "General Comfort Scale" and the "Quality of Recovery Questionnaire (Qor-40)" will be administered 24 and 48 hours after surgery. At the end of the study, the difference between the groups will be evaluated. In the analysis of this study, descriptive statistics, Shapiro-Wilk test, Chi-square test, t-test in independent groups, ANOVA test in repeated measures will be used. The main questions it aims to answer: Do earplugs and eye masks used after orthopedic surgery have an effect on comfort level? Do earplugs and eye masks used after orthopedic surgery have an effect on the quality of recovery?

Official title: Effect of Earplugs and Eye Masks Used After Orthopedic Surgery on Comfort and Quality of Recovery: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-01

Completion Date

2025-11-20

Last Updated

2025-05-23

Healthy Volunteers

No

Interventions

DEVICE

Earplugs and Eye Masks

The patients in the experimental group will be given the "Informed Consent Form" before surgery and the "Patient Introduction Form" will be applied after permission is obtained. Patients will be given eye masks and earplugs on the nights following surgery and they will be ensured to use them correctly. The "General Comfort Scale" and the "Quality of Recovery Questionnaire (Qor-40)" will be applied 24 and 48 hours after surgery.