Orthopedic SurgeryNCT06986408
Effect of Earplugs and Eye Masks Used After Orthopedic Surgery on Comfort and Quality of Recovery
A study testing Earplugs and Eye Masks in people with Orthopedic Surgery and Nursing Care, run by Ankara Yildirim Beyazıt University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery, Nursing Care, Quality of Recovery 40
- What is being tested?
- Earplugs and Eye Masks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who do not agree to participate in the study and for whom written consent was not obtained.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Earplugs and Eye Masks Used After Orthopedic Surgery on Comfort and Quality of Recovery: A Randomized Controlled 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?
Read the detailed description
In the postoperative period, patients may experience problems such as pain due to surgery, prolonged fasting, and discomfort caused by foreign equipment (catheter, drain) in their bodies. This situation further exacerbates the existing pain of the patients and reduces their comfort levels. Using more opioids to reduce increased pain negatively affects biological processes such as early mobilization and early nutrition, which are important for the recovery of surgical patients. Therefore, non-pharmacological and non-invasive nursing care practices are needed to increase the comfort levels and quality of recovery of surgical patients. Patients' comfort levels and quality of recovery decrease significantly due to environmental factors such as alarm sounds of devices, high staff turnover, and constantly on lights. When the literature is examined, it is seen that tools and equipment are needed to manage this very important problem. It has been reported that the use of eye masks and earplugs may be better than other interventions in reducing noise and controlling light. The use of eye masks and earplugs is one of the effective and independent nursing interventions. Non-pharmacological tools such as earplugs and eye masks isolate the patient from noise and light. While the effects of using tools and equipment alone or together on the comfort level are discussed in the literature to a limited extent; no study has been found evaluating the effect on the quality of recovery. In the study conducted by Altıntaş et al., it was determined that the comfort levels of the patients increased after the interventions of ergonomic sleep masks, earplugs and eye masks. In some studies, it has been reported that these devices are not comfortable despite their positive effects. While patients may wake up involuntarily when the earplug is removed during sleep, there are also cases where eye masks are not the right size for the patients' head structure and the rope part of the masks is thin and tight, which can disturb the patient. It is important that the use of eye masks and earplugs can be adjusted according to the head and ear structure in terms of patient comfort. For this reason, it is necessary to use ergonomic materials that facilitate patient adaptation, can be adjusted according to the individual, and are reusable in terms of cost effectiveness. While the effects of using earplugs and eye masks on the comfort level of patients are discussed in a limited way in the literature; no study has been found evaluating their effects on the quality of recovery. In addition, no study has been found that determines the effect of earplugs and eye masks used after orthopedic surgery on comfort and healing quality. Based on this point, it was aimed to determine the effect of earplugs and eye masks used after orthopedic surgery on comfort and healing quality.
- Conditions
- Orthopedic Surgery, Nursing Care, Quality of Recovery 40, Comfort
- Being tested
- Earplugs and Eye Masks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Earplugs and Eye MasksDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: just 24 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Yılmazer, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986408
- Sponsor's protocol ID
- EarplugsEyeMasks
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Earplugs and Eye Masks Used After Orthopedic Surgery on Comfort and Quality of Recovery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06986408
- Acronym / sponsor ID
- EarplugsEyeMasks
- Conditions
- Orthopedic Surgery, Nursing Care, Quality of Recovery 40, Comfort
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
In the postoperative period, patients may experience problems such as pain due to surgery, prolonged fasting, and discomfort caused by foreign equipment (catheter, drain) in their bodies. This situation further exacerbates the existing pain of the patients and reduces their comfort levels. Using more opioids to reduce increased pain negatively affects biological processes such as early mobilization and early nutrition, which are important for the recovery of surgical patients. Therefore, non-pharmacological and non-invasive nursing care practices are needed to increase the comfort levels and quality of recovery of surgical patients. Patients' comfort levels and quality of recovery decrease significantly due to environmental factors such as alarm sounds of devices, high staff turnover, and constantly on lights. When the literature is examined, it is seen that tools and equipment are needed to manage this very important problem. It has been reported that the use of eye masks and earplugs may be better than other interventions in reducing noise and controlling light. The use of eye masks and earplugs is one of the effective and independent nursing interventions. Non-pharmacological tools such as earplugs and eye masks isolate the patient from noise and light. While the effects of using tools and equipment alone or together on the comfort level are discussed in the literature to a limited extent; no study has been found evaluating the effect on the quality of recovery. In the study conducted by Altıntaş et al., it was determined that the comfort levels of the patients increased after the interventions of ergonomic sleep masks, earplugs and eye masks. In some studies, it has been reported that these devices are not comfortable despite their positive effects. While patients may wake up involuntarily when the earplug is removed during sleep, there are also cases where eye masks are not the right size for the patients' head structure and the rope part of the masks is thin and tight, which can disturb the patient. It is important that the use of eye masks and earplugs can be adjusted according to the head and ear structure in terms of patient comfort. For this reason, it is necessary to use ergonomic materials that facilitate patient adaptation, can be adjusted according to the individual, and are reusable in terms of cost effectiveness. While the effects of using earplugs and eye masks on the comfort level of patients are discussed in a limited way in the literature; no study has been found evaluating their effects on the quality of recovery. In addition, no study has been found that determines the effect of earplugs and eye masks used after orthopedic surgery on comfort and healing quality. Based on this point, it was aimed to determine the effect of earplugs and eye masks used after orthopedic surgery on comfort and healing quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Earplugs and Eye Masks | Experimental | Device: Earplugs and Eye MasksThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who do not agree to participate in the study and for whom written consent was not obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Earplugs and Eye MasksThe 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 |
Primary outcome
General Comfort Scale Short Form
Time frame: just 24 and 48 hours
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.
Quality of Recovery Scale (Qor-40)
Time frame: just 24 and 48 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Earplugs and Eye Masks in people with Orthopedic Surgery and Nursing Care, run by Ankara Yildirim Beyazıt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuba Yilmazer, PhD (5079552804, tyilmazer@aybu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Comfort Scale Short Form (time frame: just 24 and 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.