Effect of Earplugs and Eye Masks Used After Orthopedic Surgery on Comfort and Quality of Recovery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara Yildirim Beyazıt University
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
Patients who do not agree to participate in the study and for whom written consent was not obtained.
Trial design
Design model
Parallel
Treatments tested in this trial
Earplugs and Eye Masks
DeviceThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Earplugs and Eye MasksExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
just 24 and 48 hours2
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.
Time frame
just 24 and 48 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: