The Effect of Ear Plugs and Eye Patch on Anxiety Level During Magnetic Resonance Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ege University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- ''Change in Diastolic Blood Pressure Before and After MRI''
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
1. Earplugs ve eye mask Arm
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.
Intervention: Earplugs and eye mask (Device)
2. Control Arm
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.
Outcomes
Primary Outcomes
''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
''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 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
Secondary Outcomes
- ''Change in Heart Rate Before and after MRI''(''Post-MRI minus pre-MRI'' Measure Type/unit: bpm)
- ''Change in State- Anxiety Inventory (STAI-I)''(Pre- intervention and immediately after the intervention ''before MRI and immediately after MRI'')
- ''Change in Heart Rate Before and after MRI''(''Post-MRI minus pre-MRI'' Measure Type/unit: bpm)
- ''Change in Oxygen Saturation (SpO₂) Before and After MRI''(''Before MRI and immediately after MRI'')
- ''Change in State- Anxiety Inventory (STAI-I)''(Pre- intervention and immediately after the intervention ''before MRI and immediately after MRI'')
Investigators
Saadet Saza
Specialist Nurse
Ege University