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

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?

NCT Number	NCT06986408
Lead Sponsor	Ankara Yildirim Beyazıt University
Conditions	Orthopedic Surgery, Nursing Care, Quality of Recovery 40, Comfort
Enrollment	60 participants
Start Date	2025-06-01
Primary Completion	2025-10-31 (estimated)
Study Completion	2025-11-20 (estimated)
Updated on ClinicalTrials.gov	2025-05-23