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

NCT06348862 | Completed

• 1 other identifier: 323/REC/2023
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Stress; MRI Contrast Media Adverse Reaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Sociodemographic

  Ten to 30 minutes according to the duration of MRI

Study Arms (4)

Listening to Quran

EXPERIMENTAL

Listening to Quran during MRI

Behavioral: Listening to either Quran, Music, and or Natural sound

Listening to Music

EXPERIMENTAL

Listening to Music during MRI

Behavioral: Listening to either Quran, Music, and or Natural sound

Listening to Natural Sound

EXPERIMENTAL

Listening to Natural Sound during MRI

Behavioral: Listening to either Quran, Music, and or Natural sound

Listening to nothing

NO INTERVENTION

Listening to nothing during MRI

Interventions

Listening to either Quran, Music, and or Natural sound BEHAVIORAL

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).

Listening to Music; Listening to Natural Sound; Listening to Quran

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Quds University: lead

Study Sites (1)

Al-Quds University

East Jerusalem, Jerusalem, 00970, Palestinian Territories

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: April 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: April 1, 2025

Locations

PA (1)