AnxietyNCT04238312
Respiratory Biofeedback Device and Reduction of Dental Anxiety Associated With Local Anesthesia in Children
A study testing RESPeRATE™ and Tell, Show and Do technique in people with Anxiety, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The aim of the study was to investigate the effect of a respiratory biofeedback device (RESPeRATE TM) in reduction of preoperative anxiety in children undergoing dental procedures under local anesthesia. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Anxiety
- What is being tested?
- RESPeRATE™ and Tell, Show and Do technique
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2018to 15 Jan 2020
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Normal healthy children (physical status ASA I \& II).
- Scoring 26 or more on faces version of modified child dental anxiety scale (MCDASf).
- Dental procedure requiring local anesthesia.
- Completion of a parental consent to participate in the study.
Who cannot join
- Children on anxiolytic medication or using any medication directly related to emotional or cognitive function.
- Children with special needs.
- Children on medications that specifically agonize or antagonize alpha- or beta-adrenergic processes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Respiratory Biofeedback Device on Reduction of Dental Anxiety Associated With Local Anesthesia in Children: A Randomized Controlled Clinical Trial
The aim of the study was to investigate the effect of a respiratory biofeedback device (RESPeRATE TM) in reduction of preoperative anxiety in children undergoing dental procedures under local anesthesia.
Read the detailed description
The study was a randomized controlled clinical trial. A total of 110 anxious pediatric dental patients, of age range 7-12 years, were selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt, after securing parental informed consents. Children were chosen according to the Faces version of Modified Child Dental Anxiety Scale scoring 26 or more.
The participants will be randomly allocated into 2 groups: Group I: Study group and Group II: Control group. The patients of group I (Study group) will undergo a session of biofeedback regulation by using "RESPeRATETM" as an anxiety reducing method. Group II patients will be managed by a routine behavioral management technique "Tell,show,do". Local anesthesia injection will be administered to the child, after which heart rate measurement and salivary sample for salivary amylase analysis will be repeated.
- Conditions
- Anxiety
- Being tested
- RESPeRATE™, Tell, Show and Do technique
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPeRATE™Device
Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.
Tell, Show and Do techniqueBehavioural
Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).
| Study group | Role | What they receive |
|---|---|---|
| RESPeRATE™ | Experimental | RESPeRATE™: 2breathe Tech. Ltd., Eshtaol, Israel. The device includes a belt-type respiration sensor worn outside of the clothing that is placed around the torso. It is connected to a computerized box that generates musical patterns listened through an earbud. The device guides the user interactively to slow breathing with a relatively prolonged expiration. Receives: Device: RESPeRATE™ |
| Tell, Show and Do technique | Active comparator | Not described Receives: Behavioral: Tell, Show and Do technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Measured: baseline
Heart Rate
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Measured: after 5 minutes
Oxygen saturation
Oxygen saturation will be monitored using an oximeter
Measured: baseline
Oxygen saturation
Oxygen saturation will be monitored using an oximeter
Measured: after 5 minutes
Behavior Evaluation
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive
Measured: baseline
Behavior Evaluation
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive
Measured: after 1 week during follow-up sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start15 Dec 2018
- Primary completion18 Oct 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a randomized controlled clinical trial, with 1:1 allocation ratio.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Sarah Zeitoun, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptAmani Khalil, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptNadia Wahba, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptMohamed IS Ahmed, PhD, Study chair, Faculty of Medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238312
- Sponsor's protocol ID
- Respiratory biofeedback device
- Status last verified
- Aug 2020
- First submitted
- 18 Jan 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morarend QA, Spector ML, Dawson DV, Clark SH, Holmes DC. The use of a respiratory rate biofeedback device to reduce dental anxiety: an exploratory investigation. Appl Psychophysiol Biofeedback. 2011 Jun;36(2):63-70. doi: 10.1007/s10484-011-9148-z.
PubMed 21365307Howard KE, Freeman R. Reliability and validity of a faces version of the Modified Child Dental Anxiety Scale. Int J Paediatr Dent. 2007 Jul;17(4):281-8. doi: 10.1111/j.1365-263X.2007.00830.x.
PubMed 17559456Chipps J. Psychological therapies for the management of chronic and recurrent pain in children and adolescents: A Cochrane review summary. Int J Nurs Stud. 2021 Jan;113:103393. doi: 10.1016/j.ijnurstu.2019.103393. Epub 2019 Aug 16. No abstract available.
PubMed 31519334
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Respiratory Biofeedback Device on Reduction of Dental Anxiety Associated With Local Anesthesia in Children: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04238312
- Acronym / sponsor ID
- Respiratory biofeedback device
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 23 Jan 2020 (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 study was to investigate the effect of a respiratory biofeedback device (RESPeRATE TM) in reduction of preoperative anxiety in children undergoing dental procedures under local anesthesia.
Detailed description
The study was a randomized controlled clinical trial. A total of 110 anxious pediatric dental patients, of age range 7-12 years, were selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt, after securing parental informed consents. Children were chosen according to the Faces version of Modified Child Dental Anxiety Scale scoring 26 or more.
The participants will be randomly allocated into 2 groups: Group I: Study group and Group II: Control group. The patients of group I (Study group) will undergo a session of biofeedback regulation by using "RESPeRATETM" as an anxiety reducing method. Group II patients will be managed by a routine behavioral management technique "Tell,show,do". Local anesthesia injection will be administered to the child, after which heart rate measurement and salivary sample for salivary amylase analysis will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a randomized controlled clinical trial, with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| RESPeRATE™ | Experimental | Device: RESPeRATE™RESPeRATE™: 2breathe Tech. Ltd., Eshtaol, Israel. The device includes a belt-type respiration sensor worn outside of the clothing that is placed around the torso. It is connected to a computerized box that generates musical patterns listened through an earbud. The device guides the user interactively to slow breathing with a relatively prolonged expiration. |
| Tell, Show and Do technique | Active comparator | Behavioral: Tell, Show and Do technique |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Normal healthy children (physical status ASA I \& II).
- Scoring 26 or more on faces version of modified child dental anxiety scale (MCDASf).
- Dental procedure requiring local anesthesia.
- Completion of a parental consent to participate in the study.
Key exclusion criteria (3 listed)
- Children on anxiolytic medication or using any medication directly related to emotional or cognitive function.
- Children with special needs.
- Children on medications that specifically agonize or antagonize alpha- or beta-adrenergic processes.
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 |
|---|---|---|
| RESPeRATE™Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device. | Device | RESPeRATE™ |
| Tell, Show and Do techniqueFifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do). | Behavioural | Tell, Show and Do technique |
Primary outcome
Heart Rate
Time frame: baseline
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Heart Rate
Time frame: after 5 minutes
A finger pulse oximeter will be placed on the finger of the left hand of the child.
Oxygen saturation
Time frame: baseline
Oxygen saturation will be monitored using an oximeter
Oxygen saturation
Time frame: after 5 minutes
Oxygen saturation will be monitored using an oximeter
Behavior Evaluation
Time frame: baseline
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive
Behavior Evaluation
Time frame: after 1 week during follow-up sessions
using Frankl scale (ranges from 1-4); 1: Definitely negative, 2: negative, 3:positive and 4: definitely positive
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 20 Aug 2020.
- Background: PubMed 21365307Morarend QA, Spector ML, Dawson DV, Clark SH, Holmes DC. The use of a respiratory rate biofeedback device to reduce dental anxiety: an exploratory investigation. Appl Psychophysiol Biofeedback. 2011 Jun;36(2):63-70. doi: 10.1007/s10484-011-9148-z.
- Background: PubMed 17559456Howard KE, Freeman R. Reliability and validity of a faces version of the Modified Child Dental Anxiety Scale. Int J Paediatr Dent. 2007 Jul;17(4):281-8. doi: 10.1111/j.1365-263X.2007.00830.x.
- Background: PubMed 31519334Chipps J. Psychological therapies for the management of chronic and recurrent pain in children and adolescents: A Cochrane review summary. Int J Nurs Stud. 2021 Jan;113:103393. doi: 10.1016/j.ijnurstu.2019.103393. Epub 2019 Aug 16. No abstract available.
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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.
Sarah Zeitoun, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Amani Khalil, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Nadia Wahba, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESPeRATE™ and Tell, Show and Do technique in people with Anxiety, run by Nourhan M.Aly 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 4 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 20 Aug 2020. 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 (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238312, which also lists 3 linked publications.
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 20 Aug 2020.