Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds

Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds: A Double Blinded Parallel Randomized Controlled Study

The aim of the current study is to analyze the effect of listening to Quran or music or natural sounds on anxiety and stress level among patients undergoing MRI.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Anxiety; MRI Contrast Media Adverse Reaction
• Intervention / Treatment: Behavioral: Listening to either Quran, Music, and or Natural sound

Detailed Description

After informed consents will be obtained from patients undergoing Magnetic Resonance Image (MRI). A randomized Controlled Parallel design will be used to assess the effectiveness of listening to Quran, music, and natural sound to reduce anxiety and stress level among patients undergoing MRI in Palestine. A control group will receive the traditional care during MRI without listening to any sound, while the intervention groups will listen to either Quran, music, or natural sounds during the MRI scan. Notice that each patient will choose the preferred method to be in one of the four mentioned groups. This study will include participants with predetermined specific eligibility criteria.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Who agreed to participate in this study.
• Both sex.
• Age of 18 years and above.
• Fully conscious and oriented.

Exclusion Criteria:

• Referrals from the intensive care unit.
• Life-threatening situations.
• General ill health,
• Serious psychological disorders.
• Invasive MR imaging procedures (such as biopsies).
• Being under the age of 18, and
• Exams that were particularly scheduled for other investigations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Listening to Quran; Listening to Quran during MRI	Behavioral: Listening to either Quran, Music, and or Natural sound; Patients will be assigned into one of the four groups based on their preferences. These groups are people who will listen to either Quran, Music, Natural sound, and or nothing (control group).
Experimental: Listening to Music; Listening to Music during MRI	Behavioral: Listening to either Quran, Music, and or Natural sound; Patients will be assigned into one of the four groups based on their preferences. These groups are people who will listen to either Quran, Music, Natural sound, and or nothing (control group).
Experimental: Listening to Natural Sound; Listening to Natural Sound during MRI	Behavioral: Listening to either Quran, Music, and or Natural sound; Patients will be assigned into one of the four groups based on their preferences. These groups are people who will listen to either Quran, Music, Natural sound, and or nothing (control group).
No Intervention: Listening to nothing; Listening to nothing during MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Anxiety among patients who underwent MRI	Level of Anxiety among patients who underwent MRI	Ten to 30 minutes according to the duration of MRI
Level of Stress	Level of Stress among patients who underwent MRI	Ten to 30 minutes according to the duration of MRI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic	If Sociodemographic data such as (age, sex, level of education..etc.) will have an effect on the level of anxiety and stress after listening to the one of the three interventions (Quran, music, or natural sound).	Ten to 30 minutes according to the duration of MRI

Collaborators and Investigators

• Sponsor: Al-Quds University

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: March 31, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 323/REC/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Demographics such as age, sex, level of education, income, marital status, if work or not, type of work, if chronic disorder is present.
• IPD Sharing Time Frame: April 1, 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No