Thorax InjuriesNCT07155863
The Effect of Sensory Isolation on Anxiety in Magnetic Resonance Imaging
A study testing Earplugs and eye mask in people with Thorax Injuries and Cervical Injury Spine, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine whether the use of earplugs and eye masks in adults reduces anxiety during Manyetic Resonance Imaging. In addition, in order to evaluate the effect of earplugs and eye masks on the physiological symptoms of anxiety, the pulse rate, blood pressure, respiratory rate, and saturation… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thorax Injuries, Cervical Injury Spine, Brain Trauma
- What is being tested?
- Earplugs and eye mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 4 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who are undergoing an MRI scan for the first time,
- Those undergoing a scheduled MRI scan (emergencies will not be accepted)
- Those who are willing to participate in the study,
- MRI scans lasting at least 30 minutes,
- Those who are able to communicate verbally,
- Those who are not hospitalised are eligible for inclusion.
Who cannot join
- Those under 18 and over 65 years of age
- Patients who cannot tolerate MRI scans (those who require sedation/medication during the scan
- Patients with hearing or vision impairments,
- Pregnant or breastfeeding individuals,
- Individuals with severe comorbidities,
- Individuals with acute/chronic pain who are using analgesics,
- Individuals who cannot wear earplugs or eye patches (e.g., those with active ear infections, eye infections, or phobias),
- Individuals who refuse to participate in the study will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Manisa Celal Bayar University Hafsa Sultan Hospital
Manisa, Yunusemre, 45000
About this study
Official title: The Effect of Ear Plugs and Eye Patch on Anxiety Level During Magnetic Resonance Imaging
The aim of this study is to determine whether the use of earplugs and eye masks in adults reduces anxiety during Manyetic Resonance Imaging. In addition, in order to evaluate the effect of earplugs and eye masks on the physiological symptoms of anxiety, the pulse rate, blood pressure, respiratory rate, and saturation value of adults will be measured before and after imaging.
H0: Earplugs and eye masks have no effect on state anxiety levels. H1: Earplugs and eye masks have an effect on state anxiety levels. H2: Earplugs and eye masks have an effect on heart rate. H3: Earplugs and eye masks have an effect on respiratory rate. H4: Earplugs and eye masks have an effect on systolic blood pressure. H5: Earplugs and eye masks have an effect on diastolic blood pressure. H6: Earplugs and eye masks have an effect on saturation values.
Read the detailed description
Patients who have previously had appointments at the MR unit of Manisa Celal Bayar University Hafsa Sultan Hospital will be included in the study. In addition to the routine information provided by the MR technician to patients in the study group selected by random sampling, written consent (Informed Consent Form) will be obtained from patients who agree to participate in the study prior to MRG. The patient information form, anxiety monitoring form, and measurements of blood pressure, pulse rate, respiratory rate, and saturation rate will be recorded in the physiological signs section. Prior to imaging, the researcher will provide a brief explanation of the imaging process, and the participant will be provided with customised earplugs and an eye mask to wear during imaging. After imaging, blood pressure, pulse rate, respiratory rate, and saturation values will be measured again at 0 minutes, and the anxiety monitoring form will be completed. For the control group, written consent (Informed Consent Form) will be obtained from participants who have agreed to voluntarily participate in the study. Blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured before and after the imaging, and no intervention will be performed. The study will include patients aged 18-65 who are participating in MRI for the first time, who have voluntarily agreed to participate in the study, and who have undergone brain, thoracic, and cervical MRI scans lasting at least 30 minutes.
- Conditions
- Thorax Injuries, Cervical Injury Spine, Brain Trauma, Joint Trauma
- Being tested
- Earplugs and eye mask
- Keywords
- Manyeyic resonance imagining, anxiety, noise, earplug, eye mask
- Medical subject headings
- Thoracic Injuries, Brain Injuries, Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Earplugs and eye maskDevice
Participants in the experimental group will use earplugs and eye mask during MRI. The use of these devices aims to decrease anxiety levels caused by noise and the MRI procedure. Physiological parameters and axiety scores will be monitored throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| 1. Earplugs ve eye mask Arm | Experimental | The patient information form containing the patient's pre-imaging information, anxiety monitoring form, and physiological symptoms will be measured and recorded as necessary. The researcher will provide a brief explanation about the imaging procedure to the intervention group, and each individual will be given a single-use earplug and eye mask to wear during the imaging procedure. Immediately after the imaging procedure, the anxiety monitoring form will be completed again, and physiological symptoms will be measured and recorded. Receives: Device: Earplugs and eye mask |
| 2. Control Arm | No intervention | Participants in the control group will receive standard care without any additional experimental intervention. Physiological parameters and anxiety levels will be assessed at baseline and the end of the imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
''Change in Systolic Blood Pressure Before and After Magnetic Resonance Imaging''
Systolic blood pressure measured in seated position using an automated cuff. Change calculated as post-MRI minus pre-MRI.
Measure Type/ Unit: mmHg
Measured: Pre- intervention and immediately after the intervention. ''Before MRI and immediately after MRI''
''Change in Diastolic Blood Pressure Before and After MRI''
Diastolic blood pressure measured in seated position with an automated cuff. Change is calculated as post MRI minus pre-MRI.
Measure Type/unit: mmHg
Measured: ''Before and immediately after MRI''
Secondary outcomes (3)
''Change in Heart Rate Before and after MRI''
Heart rate measured via pulse oximetry; change is post MRI minus pre-MRI
Measured: ''Post-MRI minus pre-MRI'' Measure Type/unit: bpm
''Change in Oxygen Saturation (SpO₂) Before and After MRI''
Oxygen saturation is measured with a pulse oximeter and the unit is bpm.
Measured: ''Before MRI and immediately after MRI''
''Change in State- Anxiety Inventory (STAI-I)''
The State Anxiety Inventory is a measurement tool consisting of statements that describe how a person feels at a particular moment, while the Trait Anxiety Inventory is a measurement tool consisting of statements that describe how a person generally feels.The State-Trait Anxiety Inventory is a self-assessment inventory consisting of short statements. Items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18 items are assigned positive scores (increasing the total anxiety score), while items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 are assigned negative scores (decreasing the total anxiety score). When evaluating, a score between 1 (or -1) and 4 (or -4) is given for each item according to its positive or negative characteristic, and a constant of 50 should be added to the total score obtained. The highest possible score is 80, and the lowest is 20.
Measure Type/Unit: point.
Measured: Pre- intervention and immediately after the intervention ''before MRI and immediately after MRI''
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Oct 2025
- Primary completion4 Apr 2026
- Study completion4 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thorax InjuriesStudies of the same condition, open and under way.
- More trials run by Ege 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
- Model description
- This is a randomized, controlled, parallel- group study with 2 arms: an intervention group receiving earplugs and eye mask during MRI, and a control group receiving standard care without sensory isolation devices.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadet Saza, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155863
- Sponsor's protocol ID
- Ege-SBF-SS-01
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cevik K, Cetinkaya A, Yigit Gokbel K, Menekse B, Saza S, Tikiz C. The Effect of Abdominal Massage on Constipation in the Elderly Residing in Rest Homes. Gastroenterol Nurs. 2018 Sep/Oct;41(5):396-402. doi: 10.1097/SGA.0000000000000343.
PubMed 30272602
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ear Plugs and Eye Patch on Anxiety Level During Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT07155863
- Acronym / sponsor ID
- Ege-SBF-SS-01
- Conditions
- Thorax Injuries, Cervical Injury Spine, Brain Trauma, Joint Trauma
- Keywords
- Manyeyic resonance imagining, anxiety, noise, earplug, eye mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 4 Apr 2026 (actual)
- Study completion
- 4 Apr 2026 (actual)
- First posted
- 4 Sep 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.
The aim of this study is to determine whether the use of earplugs and eye masks in adults reduces anxiety during Manyetic Resonance Imaging. In addition, in order to evaluate the effect of earplugs and eye masks on the physiological symptoms of anxiety, the pulse rate, blood pressure, respiratory rate, and saturation value of adults will be measured before and after imaging.
H0: Earplugs and eye masks have no effect on state anxiety levels. H1: Earplugs and eye masks have an effect on state anxiety levels. H2: Earplugs and eye masks have an effect on heart rate. H3: Earplugs and eye masks have an effect on respiratory rate. H4: Earplugs and eye masks have an effect on systolic blood pressure. H5: Earplugs and eye masks have an effect on diastolic blood pressure. H6: Earplugs and eye masks have an effect on saturation values.
Detailed description
Patients who have previously had appointments at the MR unit of Manisa Celal Bayar University Hafsa Sultan Hospital will be included in the study. In addition to the routine information provided by the MR technician to patients in the study group selected by random sampling, written consent (Informed Consent Form) will be obtained from patients who agree to participate in the study prior to MRG. The patient information form, anxiety monitoring form, and measurements of blood pressure, pulse rate, respiratory rate, and saturation rate will be recorded in the physiological signs section. Prior to imaging, the researcher will provide a brief explanation of the imaging process, and the participant will be provided with customised earplugs and an eye mask to wear during imaging. After imaging, blood pressure, pulse rate, respiratory rate, and saturation values will be measured again at 0 minutes, and the anxiety monitoring form will be completed. For the control group, written consent (Informed Consent Form) will be obtained from participants who have agreed to voluntarily participate in the study. Blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured before and after the imaging, and no intervention will be performed. The study will include patients aged 18-65 who are participating in MRI for the first time, who have voluntarily agreed to participate in the study, and who have undergone brain, thoracic, and cervical MRI scans lasting at least 30 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, controlled, parallel- group study with 2 arms: an intervention group receiving earplugs and eye mask during MRI, and a control group receiving standard care without sensory isolation devices.
| Arm | Type | Receives |
|---|---|---|
| 1. Earplugs ve eye mask Arm | Experimental | Device: Earplugs and eye maskThe patient information form containing the patient's pre-imaging information, anxiety monitoring form, and physiological symptoms will be measured and recorded as necessary. The researcher will provide a brief explanation about the imaging procedure to the intervention group, and each individual will be given a single-use earplug and eye mask to wear during the imaging procedure. Immediately after the imaging procedure, the anxiety monitoring form will be completed again, and physiological symptoms will be measured and recorded. |
| 2. Control Arm | No intervention | –Participants in the control group will receive standard care without any additional experimental intervention. Physiological parameters and anxiety levels will be assessed at baseline and the end of the imaging. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those who are undergoing an MRI scan for the first time,
- Those undergoing a scheduled MRI scan (emergencies will not be accepted)
- Those who are willing to participate in the study,
- MRI scans lasting at least 30 minutes,
- Those who are able to communicate verbally,
Key exclusion criteria (8 listed)
- Those under 18 and over 65 years of age
- Patients who cannot tolerate MRI scans (those who require sedation/medication during the scan
- Patients with hearing or vision impairments,
- Pregnant or breastfeeding individuals,
- Individuals with severe comorbidities,
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 maskParticipants in the experimental group will use earplugs and eye mask during MRI. The use of these devices aims to decrease anxiety levels caused by noise and the MRI procedure. Physiological parameters and axiety scores will be monitored throughout the study. | Device | 1. Earplugs ve eye mask Arm |
Primary outcome
''Change in Systolic Blood Pressure Before and After Magnetic Resonance Imaging''
Time frame: Pre- intervention and immediately after the intervention. ''Before MRI and immediately after MRI''
Systolic blood pressure measured in seated position using an automated cuff. Change calculated as post-MRI minus pre-MRI. Measure Type/ Unit: mmHg
''Change in Diastolic Blood Pressure Before and After MRI''
Time frame: ''Before and immediately after MRI''
Diastolic blood pressure measured in seated position with an automated cuff. Change is calculated as post MRI minus pre-MRI. Measure Type/unit: mmHg
3 secondary outcomes
''Change in Heart Rate Before and after MRI''
Time frame: ''Post-MRI minus pre-MRI'' Measure Type/unit: bpm
''Change in Oxygen Saturation (SpO₂) Before and After MRI''
Time frame: ''Before MRI and immediately after MRI''
''Change in State- Anxiety Inventory (STAI-I)''
Time frame: Pre- intervention and immediately after the intervention ''before MRI and immediately after MRI''
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 30272602Cevik K, Cetinkaya A, Yigit Gokbel K, Menekse B, Saza S, Tikiz C. The Effect of Abdominal Massage on Constipation in the Elderly Residing in Rest Homes. Gastroenterol Nurs. 2018 Sep/Oct;41(5):396-402. doi: 10.1097/SGA.0000000000000343.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Earplugs and eye mask in people with Thorax Injuries and Cervical Injury Spine, run by Ege University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
''Change in Systolic Blood Pressure Before and After Magnetic Resonance Imaging'' (time frame: Pre- intervention and immediately after the intervention. ''Before MRI and immediately after MRI''). 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?
On the ClinicalTrials.gov record for NCT07155863, which also lists 1 linked publication.
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 9 Apr 2026.