The Effect of Sensory Isolation on Anxiety in Magnetic Resonance Imaging

NCT07155863 | Completed DMC

• 1 other identifier: Ege-SBF-SS-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Thorax Injuries; Cervical Injury Spine; Brain Trauma; Joint Trauma

Keywords

Manyeyic resonance imagining; anxiety; noise; earplug; eye mask

Outcome Measures

Primary Outcomes (2)

• ''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''

Secondary Outcomes (3)

• ''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''

Study Arms (2)

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.

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.

Interventions

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.

1. Earplugs ve eye mask Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Manisa Celal Bayar University Hafsa Sultan Hospital

Manisa, Yunusemre, 45000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30272602 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Thoracic Injuries; Brain Injuries, Traumatic; Anxiety Disorders

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Nurse

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 4, 2025
• Study Start: October 1, 2025
• Primary Completion: April 4, 2026
• Study Completion: April 4, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)