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

NCT06986408 | Not Yet Recruiting

• 1 other identifier: EarplugsEyeMasks
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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?

Conditions

Orthopedic Surgery; Nursing Care; Quality of Recovery 40; Comfort

Outcome Measures

Primary Outcomes (2)

• General Comfort Scale Short Form

  The scale describes individual comfort needs and the components of the concept of comfort for nursing as relief, relaxation, and overcoming problems. The highest total score that can be obtained from the scale is 168 points; the lowest total score is 28 points. A low score from the scale indicates a low comfort level.

  just 24 and 48 hours

• Quality of Recovery Scale (Qor-40)

  This scale is a 40-question survey and includes five sub-dimensions, 'Emotional State, Physical Comfort, Patient Support, Physical Independence and Pain', to evaluate the individual's own condition, pain intensity and physical and emotional conditions. The total survey score varies between 40 and 200. An increase in the total score given to the survey indicates that individuals are doing well at the expected level in the post-surgical period.

  just 24 and 48 hours

Study Arms (2)

Earplugs and Eye Masks

EXPERIMENTAL

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.

Device: Earplugs and Eye Masks

Standard of care

NO INTERVENTION

The patients in the control group will also be given the "Informed Consent Form" before the surgery and the "Patient Introduction Form" will be applied after permission is obtained. The "General Comfort Scale" and the "Quality of Recovery Questionnaire (Qor-40)" will be applied 24 and 48 hours after the surgery. The difference between the groups will be evaluated at the end of the study.

Interventions

Earplugs and Eye Masks DEVICE

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.

Earplugs and Eye Masks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who can speak and understand Turkish,
• At least 18 years old,
• No hearing impairment and not using hearing aids,
• No psychiatric diagnosis and not using psychiatric medication regularly,
• Patients who agree to participate in the study and have given written consent.

You may not qualify if:

• Patients who do not agree to participate in the study and for whom written consent was not obtained.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

MeSH Terms

Interventions

Ear Protective Devices

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Tuba Yilmazer, PhD

CONTACT

5079552804; tyilmazer@aybu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 23, 2025
• Study Start: June 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 20, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05