Clinical Trials Directory

Trials / Completed

CompletedNCT07155863

The Effect of Sensory Isolation on Anxiety in Magnetic Resonance Imaging

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
Ege University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEEarplugs 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.

Timeline

Start date
2025-10-01
Primary completion
2026-04-04
Completion
2026-04-04
First posted
2025-09-04
Last updated
2026-04-09

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07155863. Inclusion in this directory is not an endorsement.