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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06348862
• Other study ID #: 323/REC/2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Al-Quds University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• MRI Contrast Media Adverse Reaction
• Stress

Intervention

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).

Locations

Country	Name	City	State
Palestinian Territory, occupied	Al-Quds University	East Jerusalem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Al-Quds University

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Level of Stress	Level of Stress among patients who underwent MRI	Ten to 30 minutes according to the duration of MRI
Secondary	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