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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Earplugs and eye mask | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ''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 | 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 | ''Before and immediately after MRI'' |
| Measure | Description | Time Frame |
|---|---|---|
| ''Change in Heart Rate Before and after MRI'' | Heart rate measured via pulse oximetry; change is post MRI minus pre-MRI | ''Post-MRI minus pre-MRI'' Measure Type/unit: bpm |
| ''Change in Oxygen Saturation (SpOâ‚‚) Before and After MRI'' |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manisa Celal Bayar University Hafsa Sultan Hospital | Manisa | Yunusemre | 45000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30272602 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D013898 | Thoracic Injuries |
| D000070642 | Brain Injuries, Traumatic |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004430 | Ear Protective Devices |
| ID | Term |
|---|---|
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D011481 | Protective Clothing |
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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.
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A single-blind method will be used to reduce bias in the study. The evaluator, who will record physiological indicators (pulse, blood pressure, saturation value) and apply the anxiety scale, will not know which group the participants belong to.
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Oxygen saturation is measured with a pulse oximeter and the unit is bpm.
| ''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. | Pre- intervention and immediately after the intervention ''before MRI and immediately after MRI'' |
| D009422 |
| Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D001523 | Mental Disorders |
| D003020 | Clothing |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |