Fear AnxietyNCT06670729
Alternatives to Manage Dental Fear
A study testing Quran listening and silent headphones group in people with Fear Anxiety and Discomfort, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial summary
This study compares the psychological effects on patients attend the dental clinic by listening to specific audios Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fear Anxiety, Discomfort, Psychotherapy Intervention Evaluation
- What is being tested?
- Quran listening and silent headphones group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 26 Oct 2021to 31 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any patient eligible for dental treatment
- willing to participate
Who cannot join
- less than 18 years of age,
- mentally retarded,
- had hearing impairment or deafness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychotherapeutic Effect of Listening to Quran Recitation on Dental Anxiety: a Randomized Controlled Trial
This study compares the psychological effects on patients attend the dental clinic by listening to specific audios
Read the detailed description
Participants of the experimental group listened to Quran recitation using auto-controlled headphones, whereas headphones of the control group participants were silent then the two groups answer questionnaire prepared for this purpose.
- Being tested
- Quran listening, silent headphones group
- Keywords
- Quran, fear, discomfort, dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quran listeningOther
listening to quran recitation via head phone
silent headphones groupOther
headphones were silent, patient do not listen to any thing
| Study group | Role | What they receive |
|---|---|---|
| Quran listening group | Experimental | participants listen to Quran recitation Receives: Other: Quran listening |
| silent headphones | Other | participant's headphone is silent Receives: Other: silent headphones group |
What is being measured
The primary outcome is the main question the study is designed to answer.
fear
fear was assessed using a questionnaire that is based on Dental anxiety scale (DAS) and Modified Dental Anxiety scale (MDAS), statistically significant descending ranks of fear reflects effectiveness of the intervention, when statistical analysis was significant, clinical (practical) effect size was also obtained to determine the clinically effective modality of management
Measured: before, during and immediately after dental session
discomfort
presence or absence of discomfort was assessed using dental anxiety scale and modified dental anxiety scale, descending ranks of fear reflects effectiveness of the intervention
Measured: during and immediately after dental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start26 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abrar Nizar Al-Attar, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670729
- Sponsor's protocol ID
- REC108
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapeutic Effect of Listening to Quran Recitation on Dental Anxiety: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06670729
- Acronym / sponsor ID
- REC108
- Keywords
- Quran, fear, discomfort, dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Nov 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.
This study compares the psychological effects on patients attend the dental clinic by listening to specific audios
Detailed description
Participants of the experimental group listened to Quran recitation using auto-controlled headphones, whereas headphones of the control group participants were silent then the two groups answer questionnaire prepared for this purpose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quran listening group | Experimental | Other: Quran listeningparticipants listen to Quran recitation |
| silent headphones | Other | Other: silent headphones groupparticipant's headphone is silent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- any patient eligible for dental treatment
- willing to participate
Key exclusion criteria (3 listed)
- less than 18 years of age,
- mentally retarded,
- had hearing impairment or deafness
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 |
|---|---|---|
| Quran listeninglistening to quran recitation via head phone | Other | Quran listening group |
| silent headphones groupheadphones were silent, patient do not listen to any thing | Other | silent headphones |
Primary outcome
fear
Time frame: before, during and immediately after dental session
fear was assessed using a questionnaire that is based on Dental anxiety scale (DAS) and Modified Dental Anxiety scale (MDAS), statistically significant descending ranks of fear reflects effectiveness of the intervention, when statistical analysis was significant, clinical (practical) effect size was also obtained to determine the clinically effective modality of management
discomfort
Time frame: during and immediately after dental session
presence or absence of discomfort was assessed using dental anxiety scale and modified dental anxiety scale, descending ranks of fear reflects effectiveness of the intervention
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 1 Nov 2024.
- Individual participant dataSharing planned: No
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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 Quran listening and silent headphones group in people with Fear Anxiety and Discomfort, run by Al-Mustansiriyah University at 1 site in Iraq.
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 2 inclusion and 3 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 1 Nov 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 Iraq. 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?
fear (time frame: before, during and immediately after dental session). 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 1 Nov 2024.