AnxietyNCT06348862
Assessment of Stress and Anxiety for Patients Undergoing MRI Using, Holy Quran, Music, and Natural Sounds
A study testing Listening to either Quran, Music, and or Natural sound in people with Anxiety and Stress, run by Al-Quds University at 1 site in Palestinian Territories.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Stress, MRI Contrast Media Adverse Reaction
- What is being tested?
- Listening to either Quran, Music, and or Natural sound
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Apr 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Who agreed to participate in this study.
- Both sex.
- Age of 18 years and above.
- Fully conscious and oriented.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Al-Quds University
East Jerusalem, Jerusalem, 00970
About this study
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
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.
Read the 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.
- Conditions
- Anxiety, Stress, MRI Contrast Media Adverse Reaction
- Being tested
- Listening to either Quran, Music, and or Natural sound
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to either Quran, Music, and or Natural soundBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Listening to Quran | Experimental | Listening to Quran during MRI Receives: Behavioral: Listening to either Quran, Music, and or Natural sound |
| Listening to Music | Experimental | Listening to Music during MRI Receives: Behavioral: Listening to either Quran, Music, and or Natural sound |
| Listening to Natural Sound | Experimental | Listening to Natural Sound during MRI Receives: Behavioral: Listening to either Quran, Music, and or Natural sound |
| Listening to nothing | No intervention | Listening to nothing during MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Anxiety among patients who underwent MRI
Level of Anxiety among patients who underwent MRI
Measured: Ten to 30 minutes according to the duration of MRI
Level of Stress
Level of Stress among patients who underwent MRI
Measured: Ten to 30 minutes according to the duration of MRI
Secondary outcomes (1)
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).
Measured: Ten to 30 minutes according to the duration of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Quds University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348862
- Sponsor's protocol ID
- 323/REC/2023
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographics such as age, sex, level of education, income, marital status, if work or not, type of work, if chronic disorder is present.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06348862
- Acronym / sponsor ID
- 323/REC/2023
- Conditions
- Anxiety, Stress, MRI Contrast Media Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Al-Quds UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Listening to Quran | Experimental | Behavioral: Listening to either Quran, Music, and or Natural soundListening to Quran during MRI |
| Listening to Music | Experimental | Behavioral: Listening to either Quran, Music, and or Natural soundListening to Music during MRI |
| Listening to Natural Sound | Experimental | Behavioral: Listening to either Quran, Music, and or Natural soundListening to Natural Sound during MRI |
| Listening to nothing | No intervention | –Listening to nothing during MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Who agreed to participate in this study.
- Both sex.
- Age of 18 years and above.
- Fully conscious and oriented.
Key exclusion criteria (7 listed)
- Referrals from the intensive care unit.
- Life-threatening situations.
- General ill health,
- Serious psychological disorders.
- Invasive MR imaging procedures (such as biopsies).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listening to either Quran, Music, and or Natural soundPatients 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). | Behavioural | Listening to Music, Listening to Natural Sound, Listening to Quran |
Primary outcome
Level of Anxiety among patients who underwent MRI
Time frame: Ten to 30 minutes according to the duration of MRI
Level of Anxiety among patients who underwent MRI
Level of Stress
Time frame: Ten to 30 minutes according to the duration of MRI
Level of Stress among patients who underwent MRI
1 secondary outcome
Sociodemographic
Time frame: Ten to 30 minutes according to the duration of MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Yes. Demographics such as age, sex, level of education, income, marital status, if work or not, type of work, if chronic disorder is present.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to either Quran, Music, and or Natural sound in people with Anxiety and Stress, run by Al-Quds University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Anxiety among patients who underwent MRI (time frame: Ten to 30 minutes according to the duration of MRI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.