Dental AnxietyNCT06279091
Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction
A study testing Diaphragmatic Breathing, Bubble Blower Breathing and Tell Show Do in people with Dental Anxiety, run by Mansoura University at 1 site in Egypt.
Trial summary
The purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Diaphragmatic Breathing, Bubble Blower Breathing and Tell Show Do
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2023to 23 May 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5_8 years old.
- Moderate or severe dental anxiety based on the (CDAS).
- Good general health, free from any systemic diseases or psychological disorders.
- Teeth indicated for restoration treatment under local anesthesia.
- No allergy to anesthetic drugs
Who cannot join
- Use of analgesics before treatment.
- Presenting with acute pain and requiring emergency dental treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction.
Read the detailed description
This study evaluated The Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction
- Conditions
- Dental Anxiety
- Being tested
- Diaphragmatic Breathing, Bubble Blower Breathing, Tell Show Do
- Keywords
- Dental anxiety, Parental anxiety, Breathing Exercises, Bubble Blower Breathing, Diaphragmatic Breathing, Relaxation, Distruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic BreathingBehavioural
apply breathing exercises to evaluate the effectiveness on anxiety reduction
Bubble Blower BreathingBehavioural
apply breathing exercises by using bubble blower to evaluate the effectiveness on anxiety reduction
Tell Show DoBehavioural
apply basic behavioral management technique as control group
| Study group | Role | What they receive |
|---|---|---|
| tell show do technique | Experimental | apply normal treatment with basic behavioral technique as a control group. Receives: Behavioral: Tell Show Do |
| Diaphragmatic breathing technique | Experimental | apply normal treatment with breathing exercises as relaxation and distruction technique to reduce the dental anxiety. Receives: Behavioral: Diaphragmatic Breathing |
| Bubble Blower breathing technique | Experimental | apply normal treatment with breathing exercises by bubbleblower which is a play therapy as relaxation and distruction technique to reduce the dental anxiety. Receives: Behavioral: Bubble Blower Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
scale of dental anxiety by Corah Dental Anxiety Scale (CDAS)
The CDAS is composed of four questions, with each question offering five possible responses. These responses are rated on a scale from 1 (representing no anxiety) to 5 (indicating extreme anxiety). The total anxiety score, which ranges from 4 to 20, is calculated by summing the scores from these questions. This scale categorizes anxiety levels as low (CDAS 4-8), moderate (CDAS 9-12), and high anxiety (CDAS 13-20).
this scale used to evaluate correlation of children and parental anxiety.
Measured: up to 12 Weeks
scale of dental anxiety by Facial Image Scale (FIS)
It consists of a single item with five response options, represented by faces ranging from severely happy(1) to very sad (5).
Measured: up to 12 Weeks
scale of dental anxiety by Venham Clinical Anxiety Scale (VCAS)
This scale rates anxiety levels on a scale from 0 to 5. A score of 0 indicates relaxation, smiling, willingness, and the ability to converse. On the other hand, a score of 5 represents general loud crying and an inability to engage in verbal communication or cope with the situation.
Measured: up to 12 Weeks
scale of dental anxiety by Pulse Oximeter
To measure heart rate
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start23 May 2023
- Primary completion5 Nov 2023
- Study completion23 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Model description
- Selected children will be divided randomly into 3 groups: Control group (Group I). Diaphragmatic Breathing group (Group II). Bubble Blower Breathing group (Group III).
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Albakr, Mansoura University
- Investigators
- Alaa M Albakr, Master, Principal investigator, Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura UniversitySalwa M Awad, Prof, Study director, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura UniversityRizk A Elagamy, PhD, Study director, Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279091
- Sponsor's protocol ID
- A0104023PP
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol to other Researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction
- ClinicalTrials.gov ID
- NCT06279091
- Acronym / sponsor ID
- A0104023PP
- Conditions
- Dental Anxiety
- Keywords
- Dental anxiety, Parental anxiety, Breathing Exercises, Bubble Blower Breathing, Diaphragmatic Breathing, Relaxation, Distruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 5 Nov 2023 (actual)
- Study completion
- 23 May 2024 (estimated)
- First posted
- 26 Feb 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 purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction.
Detailed description
This study evaluated The Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Selected children will be divided randomly into 3 groups: Control group (Group I). Diaphragmatic Breathing group (Group II). Bubble Blower Breathing group (Group III).
| Arm | Type | Receives |
|---|---|---|
| tell show do technique | Experimental | Behavioral: Tell Show Doapply normal treatment with basic behavioral technique as a control group. |
| Diaphragmatic breathing technique | Experimental | Behavioral: Diaphragmatic Breathingapply normal treatment with breathing exercises as relaxation and distruction technique to reduce the dental anxiety. |
| Bubble Blower breathing technique | Experimental | Behavioral: Bubble Blower Breathingapply normal treatment with breathing exercises by bubbleblower which is a play therapy as relaxation and distruction technique to reduce the dental anxiety. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 5_8 years old.
- Moderate or severe dental anxiety based on the (CDAS).
- Good general health, free from any systemic diseases or psychological disorders.
- Teeth indicated for restoration treatment under local anesthesia.
- No allergy to anesthetic drugs
Key exclusion criteria (2 listed)
- Use of analgesics before treatment.
- Presenting with acute pain and requiring emergency dental treatment.
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 |
|---|---|---|
| Diaphragmatic Breathingapply breathing exercises to evaluate the effectiveness on anxiety reduction | Behavioural | Diaphragmatic breathing technique |
| Bubble Blower Breathingapply breathing exercises by using bubble blower to evaluate the effectiveness on anxiety reduction | Behavioural | Bubble Blower breathing technique |
| Tell Show Doapply basic behavioral management technique as control group | Behavioural | tell show do technique |
Primary outcome
scale of dental anxiety by Corah Dental Anxiety Scale (CDAS)
Time frame: up to 12 Weeks
The CDAS is composed of four questions, with each question offering five possible responses. These responses are rated on a scale from 1 (representing no anxiety) to 5 (indicating extreme anxiety). The total anxiety score, which ranges from 4 to 20, is calculated by summing the scores from these questions. This scale categorizes anxiety levels as low (CDAS 4-8), moderate (CDAS 9-12), and high anxiety (CDAS 13-20). this scale used to evaluate correlation of children and parental anxiety.
scale of dental anxiety by Facial Image Scale (FIS)
Time frame: up to 12 Weeks
It consists of a single item with five response options, represented by faces ranging from severely happy(1) to very sad (5).
scale of dental anxiety by Venham Clinical Anxiety Scale (VCAS)
Time frame: up to 12 Weeks
This scale rates anxiety levels on a scale from 0 to 5. A score of 0 indicates relaxation, smiling, willingness, and the ability to converse. On the other hand, a score of 5 represents general loud crying and an inability to engage in verbal communication or cope with the situation.
scale of dental anxiety by Pulse Oximeter
Time frame: up to 12 weeks
To measure heart rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Yes. Study Protocol to other Researchers
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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.
Alaa M Albakr, Master principal investigator
Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University
Salwa M Awad, Prof study director
Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University
Rizk A Elagamy, PhD study director
Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Breathing, Bubble Blower Breathing and Tell Show Do in people with Dental Anxiety, run by Mansoura University at 1 site in Egypt.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Feb 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 Egypt. 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?
Results are not available in the source record.
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?
scale of dental anxiety by Corah Dental Anxiety Scale (CDAS) (time frame: up to 12 Weeks). The study lists 4 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 26 Feb 2024.