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Completed

NCT Number: NCT07155863

The Effect of Sensory Isolation on Anxiety in 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.

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Key information

Conditions

Thorax Injuries Anxiety Disorders Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Trauma Central Nervous System Diseases Cervical Injury Spine Craniocerebral Trauma Joint Trauma Mental Disorders Nervous System Diseases Thoracic Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manisa Celal Bayar University Hafsa Sultan Hospital

Manisa, Yunusemre, 45000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. ''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

  2. ''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

  1. ''Change in Heart Rate Before and after MRI''

    Time frame: ''Post-MRI minus pre-MRI'' Measure Type/unit: bpm

    Heart rate measured via pulse oximetry; change is post MRI minus pre-MRI

  2. ''Change in Oxygen Saturation (SpO₂) Before and After MRI''

    Time frame: ''Before MRI and immediately after MRI''

    Oxygen saturation is measured with a pulse oximeter and the unit is bpm.

  3. ''Change in State- Anxiety Inventory (STAI-I)''

    Time frame: Pre- intervention and immediately after the intervention ''before MRI and immediately after MRI''

    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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effect of Ear Plugs and Eye Patch on Anxiety Level During Magnetic Resonance Imaging

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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