Dental AnxietyNCT06698523
To Assess Breathing Exercise as a Relaxation Method
A study testing Breathing exercise and Deep breathing in people with Dental Anxiety, run by Ain Shams University at 1 site in Egypt.
Trial summary
in this study investigator evaluate the effectiveness of breathing exercise using two different play toys in reducing dental anxiety. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Breathing exercise and Deep breathing
- 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
- 1 Jul 2024to 30 Sep 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children that had been introduced to dental setting without receiving any dental treatment
- According to Corah 's dental anxiety scale children classified with score 19 or more
- No learning disability or psychological disorder or parental anxiety
Who cannot join
- children in emergency visit
- Allergy to anesthetic drugs
- Use of analgesic before treatment
- Teeth with necrotic pulp
- children whose parents refused to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bubble-Blower Exercise and Pin-Wheel Exercise on Dental Anxiety in Children: A Randomized Controlled Trial
in this study investigator evaluate the effectiveness of breathing exercise using two different play toys in reducing dental anxiety.
Read the detailed description
bubble blower and pin wheel are used to facilitate breathing exercise and to reduce dental anxiety hence more cooperation of participants during dental treatment
- Conditions
- Dental Anxiety
- Being tested
- Breathing exercise, Deep breathing
- Keywords
- breathing exercise, play toys, heart rate, venham picture test, salivary alpha amylase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseBehavioural
Also called bubble blower exercise
bubble blower used as play toys to facilitate the breathing exercise
Deep breathingBehavioural
pin wheel used as a play toy for achievement of breathing exercise
| Study group | Role | What they receive |
|---|---|---|
| Tell- show-Do | No intervention | Control group |
| Bubble-blower | Experimental | breathing exercise technique using bubble-blower Receives: Behavioral: Breathing exercise |
| Pin-wheel | Experimental | breathing exercise technique using Pin-wheel Receives: Behavioral: Deep breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate to assess child's dental anxiety
correlating participants anxiety to heart rate the higher the heart rate indicating the higher the anxiety level of patients
Measured: during dental treatment after local anesthetic injection. Heart rate is measured in beats/min measured twice, first before any dental treatment and measured a second time after 7-10 minutes after injection of local anesthesia
Venham picture test used to assess dental anxiety
score 0-8, it is an eight cards photos that are shown to children if child chooses the more anxious child in picture this is recorded as a score, the higher the score the more anxious the participants.
Measured: during dental treatment recorded before any treatment is done and after five minutes of injection of local anesthesia
Salivary Alpha amylase
collecting saliva sample for assessment of alpha amylase by ELISA test, saliva collected twice before and after injection of local anesthesia and correlating concentration to dental anxiety the higher the concentration of alpha amylase indicates more anxious children
Measured: before any dental treatment is done and 7-10 minutes after injection of local anesthesia
Secondary outcomes (1)
Innovation of a new protocol in behavior management prior to painful dental procedure
breathing exercise using play toys as behavior management
Measured: during dental treatment that will take 15-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Passant Mohamed Ibrahim Attia Elbahy, Ain Shams University
- Investigators
- Passant Elbahy, Principal investigator, Ain Shams University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698523
- Sponsor's protocol ID
- PED23-4M
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 21 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bubble-Blower Exercise and Pin-Wheel Exercise on Dental Anxiety in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06698523
- Acronym / sponsor ID
- PED23-4M
- Conditions
- Dental Anxiety
- Keywords
- breathing exercise, play toys, heart rate, venham picture test, salivary alpha amylase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 21 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.
in this study investigator evaluate the effectiveness of breathing exercise using two different play toys in reducing dental anxiety.
Detailed description
bubble blower and pin wheel are used to facilitate breathing exercise and to reduce dental anxiety hence more cooperation of participants during dental treatment
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tell- show-Do | No intervention | –Control group |
| Bubble-blower | Experimental | Behavioral: Breathing exercisebreathing exercise technique using bubble-blower |
| Pin-wheel | Experimental | Behavioral: Deep breathingbreathing exercise technique using Pin-wheel |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children that had been introduced to dental setting without receiving any dental treatment
- According to Corah 's dental anxiety scale children classified with score 19 or more
- No learning disability or psychological disorder or parental anxiety
Key exclusion criteria (5 listed)
- children in emergency visit
- Allergy to anesthetic drugs
- Use of analgesic before treatment
- Teeth with necrotic pulp
- children whose parents refused to sign informed consent
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 |
|---|---|---|
| Breathing exerciseAlso: bubble blower exercisebubble blower used as play toys to facilitate the breathing exercise | Behavioural | Bubble-blower |
| Deep breathingpin wheel used as a play toy for achievement of breathing exercise | Behavioural | Pin-wheel |
Primary outcome
Heart rate to assess child's dental anxiety
Time frame: during dental treatment after local anesthetic injection. Heart rate is measured in beats/min measured twice, first before any dental treatment and measured a second time after 7-10 minutes after injection of local anesthesia
correlating participants anxiety to heart rate the higher the heart rate indicating the higher the anxiety level of patients
Venham picture test used to assess dental anxiety
Time frame: during dental treatment recorded before any treatment is done and after five minutes of injection of local anesthesia
score 0-8, it is an eight cards photos that are shown to children if child chooses the more anxious child in picture this is recorded as a score, the higher the score the more anxious the participants.
Salivary Alpha amylase
Time frame: before any dental treatment is done and 7-10 minutes after injection of local anesthesia
collecting saliva sample for assessment of alpha amylase by ELISA test, saliva collected twice before and after injection of local anesthesia and correlating concentration to dental anxiety the higher the concentration of alpha amylase indicates more anxious children
1 secondary outcome
Innovation of a new protocol in behavior management prior to painful dental procedure
Time frame: during dental treatment that will take 15-30 minutes
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 21 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Dental Anxiety
Recruiting
Evaluating Operation Calm With Children, Parents, and Clinicians
Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Not yet recruiting
Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children
Dental Anxiety in Children
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
Not yet recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
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.
Passant Elbahy principal investigator
Ain Shams University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise and Deep breathing in people with Dental Anxiety, run by Ain Shams 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 3 inclusion and 5 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 21 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 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?
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?
Heart rate to assess child's dental anxiety (time frame: during dental treatment after local anesthetic injection. Heart rate is measured in beats/min measured twice, first before any dental treatment and measured a second time after 7-10 minutes after injection of local anesthesia). The study lists 3 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 21 Nov 2024; AzTrials last refreshed its copy on 29 Oct 2026.