AnxietyNCT04731181
Effectiveness of Mobile Applications During the Administration of Local Anesthesia in Pediatric Dentistry
A study testing mobile application (little lovely dentist). in people with Anxiety, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate the mobile games' effect on patient acceptance of local anesthesia and decreasing dental pain and anxiety levels in pediatric patients. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- mobile application (little lovely dentist).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 May 2023
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-6 years.
- Children without any systemic or mental disorders.
- Children without any prior experience with the dental environment or treatment procedures (first dental visit).
- Children whose behavior could be rated as positive or negative based on the Frankl behavior rating scale.
Who cannot join
- Children seeking dental treatment that does not necessitate local anesthesia.
- Children suffering from any systemic or mental disorders.
- Children who are not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile App (Little Lovely Dentist) Versus Tell-Show-Do Technique in Reduction of Anxiety and Pain During Administration of Local Anaesthesia in Children (A Randomized Clinical Trial)
To evaluate the mobile games' effect on patient acceptance of local anesthesia and decreasing dental pain and anxiety levels in pediatric patients.
Read the detailed description
a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: mobile application (little lovely dentist) control group: Tell-Show-Do technique. in children aged 4-6 years who need local anesthesia for dental treatment during their first dental visit.
For both groups:
Verbal assent from participating patients and written consent from their legal guardians will be taken.
- Taking personal data, medical and dental history.
- Diagnosis and determination of the required treatment.
- Measuring preoperative anxiety using a pulse oximeter.
- Evaluate preoperative anxiety using RMS-pictorial scale.
- Using the behavior guidance technique: Intervention group: Allow the child to play the module simulating the required procedure. Control group: tell-show-do technique is used to explain the procedure to the child
- Administration of local anesthesia and evaluation of child behaviour during the administration of local anaesthesia using Venham's behaviour rating scale and Frankl behaviour rating scale .
- Measuring postoperative anxiety using the pulse oximeter.
- Evaluate postoperative anxiety using RMS-pictorial scale.
- Evaluate postoperative pain using the visual analog scale. in second visit (after 1 week)
- Evaluation of child behavior during the second dental visit using Venham's behavior rating scale and Frankl behavior rating scale. outcome:
- ry: Pre and postoperative anxiety using Pulse oximeter and RMS-pictorial scale.
- ry: Postoperative pain using Visual analog scale, evaluation of attitude during the administration of local anaesthesia at first and second dental visits using -Venham's behavior rating scale-Frankl behavior rating scale. the study will be held in 2 visits.
- Conditions
- Anxiety
- Being tested
- mobile application (little lovely dentist).
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile application (little lovely dentist).Behavioural
mobile application
| Study group | Role | What they receive |
|---|---|---|
| mobile application (little lovely dentist). | Experimental | intervention mobile application simulating the dental procedure that will be done to the child Receives: Behavioral: mobile application (little lovely dentist). |
| Tell-Show-Do technique. | No intervention | control behavior technique where ''tell'' is to tell the child about the procedure in non-threatening words, ''show'' is to demonstrate the procedure to the child, and ''do'' is the execution of the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety
Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)
Measured: before administration of local anesthesia during the first dental visit
postoperative anxiety
postoperative anxiety will be measured immediately after administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)
Measured: immediately after administration of local anesthesia during the first dental visit
Preoperative anxiety score
will be assessed by RMS-pictorial scale ( Raghavendra, Madhuri, Sujata - pictorial scale) before administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
Measured: before administration of local anesthesia during the first dental visit
post-operative anxiety score
will be assessed by RMS-pictorial scale ( Raghavendra, Madhuri, Sujata - pictorial scale) immediately after administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
Measured: immediately after administration of local anesthesia during the first dental visit
Secondary outcomes (3)
Postoperative pain
Postoperative pain will be measured immediately after administration of local anesthesia by the visual analog scale in a numerical unit 0-10 where 0 denotes no pain and 10 denotes the worst pain
Measured: immediately after administration of local anesthesia during the first dental visit
Attitude during the first and second dental visits using frankle behavior rating scale
evaluation of child behavior during the first and second visits using frankle behavior rating scale in a numerical unit rating 1-4 where,
- Definitely Negative: Refusal of treatment, crying forcefully, fearful, or any other overt evidence of extreme negativism.
- Negative: Reluctant to accept treatment, uncooperative, some evidence of negative attitude but not pronounced withdrawn.
- Positive: Acceptance of treatment; at times curious, willing to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively
- Definitely positive:
Good rapport with the dentist, interested in dental procedures, and laughing and enjoying the situation.
Measured: during administration of local anasthesia during the the first and second dental visits (after 1 week)
Attitude during the first and second dental visits using Venham's behavior rating scale
evaluation of child behavior during the first and second visits using Venham's behavior rating scale in a numerical unit using score 0-3 where, 0- Total cooperation, best working conditions, no crying, or physical protest.
- Mild, soft verbal protest or quiet crying as a signal of discomfort, but doesn't obstruct progress. Appropriate behavior for the procedure.
- Protest more prominent. Both crying and hand signals. May move head around making it hard to perform the treatment. Protest more distracting and troublesome. However, the child still complies with the request to cooperate.
- Protest presents a real problem to the dentist. Complies with demands reluctantly, requiring more effort by dentist + Body movement.
Measured: during administration of local anasthesia during the first and second dental visits (after 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Oct 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group and allocation ratio (1:1) Intervention: mobile application (little lovely dentist). Control: Tell-Show-Do technique.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian Mamdouh Sedky Reda, Cairo University
- Investigators
- Passant Nagi, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731181
- Sponsor's protocol ID
- mobile app in dentistry
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Steimer T. The biology of fear- and anxiety-related behaviors. Dialogues Clin Neurosci. 2002 Sep;4(3):231-49. doi: 10.31887/DCNS.2002.4.3/tsteimer.
PubMed 22033741Saatchi M, Abtahi M, Mohammadi G, Mirdamadi M, Binandeh ES. The prevalence of dental anxiety and fear in patients referred to Isfahan Dental School, Iran. Dent Res J (Isfahan). 2015 May-Jun;12(3):248-53.
PubMed 26005465Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.
PubMed 28879259Ghanei M, Arnrup K, Robertson A. Procedural pain in routine dental care for children: a part of the Swedish BITA study. Eur Arch Paediatr Dent. 2018 Oct;19(5):365-372. doi: 10.1007/s40368-018-0368-2. Epub 2018 Sep 7.
PubMed 30194611Shetty RM, Khandelwal M, Rath S. RMS Pictorial Scale (RMS-PS): an innovative scale for the assessment of child's dental anxiety. J Indian Soc Pedod Prev Dent. 2015 Jan-Mar;33(1):48-52. doi: 10.4103/0970-4388.149006.
PubMed 25572374Monteiro J, Tanday A, Ashley PF, Parekh S, Alamri H. Interventions for increasing acceptance of local anaesthetic in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2020 Feb 27;2(2):CD011024. doi: 10.1002/14651858.CD011024.pub2.
PubMed 32104910Saxena P, Gupta SK, Newaskar V, Chandra A. Advances in dental local anesthesia techniques and devices: An update. Natl J Maxillofac Surg. 2013 Jan;4(1):19-24. doi: 10.4103/0975-5950.117873.
PubMed 24163548Behavior Guidance for the Pediatric Dental Patient. Pediatr Dent. 2017 Sep 15;39(6):246-259. No abstract available.
PubMed 29179365Radhakrishna S, Srinivasan I, Setty JV, D R MK, Melwani A, Hegde KM. Comparison of three behavior modification techniques for management of anxious children aged 4-8 years. J Dent Anesth Pain Med. 2019 Feb;19(1):29-36. doi: 10.17245/jdapm.2019.19.1.29. Epub 2019 Feb 28.
PubMed 30859131
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile App (Little Lovely Dentist) Versus Tell-Show-Do Technique in Reduction of Anxiety and Pain During Administration of Local Anaesthesia in Children (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04731181
- Acronym / sponsor ID
- mobile app in dentistry
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 29 Jan 2021 (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.
To evaluate the mobile games' effect on patient acceptance of local anesthesia and decreasing dental pain and anxiety levels in pediatric patients.
Detailed description
a randomized clinical trial with parallel-group and allocation ratio (1:1). intervention group: mobile application (little lovely dentist) control group: Tell-Show-Do technique. in children aged 4-6 years who need local anesthesia for dental treatment during their first dental visit.
For both groups:
Verbal assent from participating patients and written consent from their legal guardians will be taken.
- Taking personal data, medical and dental history.
- Diagnosis and determination of the required treatment.
- Measuring preoperative anxiety using a pulse oximeter.
- Evaluate preoperative anxiety using RMS-pictorial scale.
- Using the behavior guidance technique: Intervention group: Allow the child to play the module simulating the required procedure. Control group: tell-show-do technique is used to explain the procedure to the child
- Administration of local anesthesia and evaluation of child behaviour during the administration of local anaesthesia using Venham's behaviour rating scale and Frankl behaviour rating scale .
- Measuring postoperative anxiety using the pulse oximeter.
- Evaluate postoperative anxiety using RMS-pictorial scale.
- Evaluate postoperative pain using the visual analog scale. in second visit (after 1 week)
- Evaluation of child behavior during the second dental visit using Venham's behavior rating scale and Frankl behavior rating scale. outcome:
- ry: Pre and postoperative anxiety using Pulse oximeter and RMS-pictorial scale.
- ry: Postoperative pain using Visual analog scale, evaluation of attitude during the administration of local anaesthesia at first and second dental visits using -Venham's behavior rating scale-Frankl behavior rating scale. the study will be held in 2 visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel-group and allocation ratio (1:1) Intervention: mobile application (little lovely dentist). Control: Tell-Show-Do technique.
| Arm | Type | Receives |
|---|---|---|
| mobile application (little lovely dentist). | Experimental | Behavioral: mobile application (little lovely dentist).intervention mobile application simulating the dental procedure that will be done to the child |
| Tell-Show-Do technique. | No intervention | –control behavior technique where ''tell'' is to tell the child about the procedure in non-threatening words, ''show'' is to demonstrate the procedure to the child, and ''do'' is the execution of the procedure |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 4-6 years.
- Children without any systemic or mental disorders.
- Children without any prior experience with the dental environment or treatment procedures (first dental visit).
- Children whose behavior could be rated as positive or negative based on the Frankl behavior rating scale.
Key exclusion criteria (3 listed)
- Children seeking dental treatment that does not necessitate local anesthesia.
- Children suffering from any systemic or mental disorders.
- Children who are not willing to participate in the study
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 |
|---|---|---|
| mobile application (little lovely dentist).mobile application | Behavioural | mobile application (little lovely dentist). |
Primary outcome
Preoperative anxiety
Time frame: before administration of local anesthesia during the first dental visit
Preoperative anxiety will be measured before administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)
postoperative anxiety
Time frame: immediately after administration of local anesthesia during the first dental visit
postoperative anxiety will be measured immediately after administration of local anesthesia using a fingertip pulse oximeter (IMDK) in beat per minute unit (BPM)
Preoperative anxiety score
Time frame: before administration of local anesthesia during the first dental visit
will be assessed by RMS-pictorial scale ( Raghavendra, Madhuri, Sujata - pictorial scale) before administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
post-operative anxiety score
Time frame: immediately after administration of local anesthesia during the first dental visit
will be assessed by RMS-pictorial scale ( Raghavendra, Madhuri, Sujata - pictorial scale) immediately after administration of local anesthesia in a numerical unit from 1-5 where 1 denotes the minimum anxiety and 5 denotes the maximum anxiety
3 secondary outcomes
Postoperative pain
Time frame: immediately after administration of local anesthesia during the first dental visit
Attitude during the first and second dental visits using frankle behavior rating scale
Time frame: during administration of local anasthesia during the the first and second dental visits (after 1 week)
Attitude during the first and second dental visits using Venham's behavior rating scale
Time frame: during administration of local anasthesia during the first and second dental visits (after 1 week)
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 7 Feb 2024.
- Results publication: PubMed 22033741Steimer T. The biology of fear- and anxiety-related behaviors. Dialogues Clin Neurosci. 2002 Sep;4(3):231-49. doi: 10.31887/DCNS.2002.4.3/tsteimer.
- Results publication: PubMed 26005465Saatchi M, Abtahi M, Mohammadi G, Mirdamadi M, Binandeh ES. The prevalence of dental anxiety and fear in patients referred to Isfahan Dental School, Iran. Dent Res J (Isfahan). 2015 May-Jun;12(3):248-53.
- Results publication: PubMed 28879259Shim YS, Kim AH, Jeon EY, An SY. Dental fear & anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.
- Results publication: PubMed 30194611Ghanei M, Arnrup K, Robertson A. Procedural pain in routine dental care for children: a part of the Swedish BITA study. Eur Arch Paediatr Dent. 2018 Oct;19(5):365-372. doi: 10.1007/s40368-018-0368-2. Epub 2018 Sep 7.
- Results publication: PubMed 25572374Shetty RM, Khandelwal M, Rath S. RMS Pictorial Scale (RMS-PS): an innovative scale for the assessment of child's dental anxiety. J Indian Soc Pedod Prev Dent. 2015 Jan-Mar;33(1):48-52. doi: 10.4103/0970-4388.149006.
- Results publication: PubMed 32104910Monteiro J, Tanday A, Ashley PF, Parekh S, Alamri H. Interventions for increasing acceptance of local anaesthetic in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2020 Feb 27;2(2):CD011024. doi: 10.1002/14651858.CD011024.pub2.
- Results publication: PubMed 24163548Saxena P, Gupta SK, Newaskar V, Chandra A. Advances in dental local anesthesia techniques and devices: An update. Natl J Maxillofac Surg. 2013 Jan;4(1):19-24. doi: 10.4103/0975-5950.117873.
- Results publication: PubMed 29179365Behavior Guidance for the Pediatric Dental Patient. Pediatr Dent. 2017 Sep 15;39(6):246-259. No abstract available.
- Results publication: PubMed 30859131Radhakrishna S, Srinivasan I, Setty JV, D R MK, Melwani A, Hegde KM. Comparison of three behavior modification techniques for management of anxious children aged 4-8 years. J Dent Anesth Pain Med. 2019 Feb;19(1):29-36. doi: 10.17245/jdapm.2019.19.1.29. Epub 2019 Feb 28.
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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.
Passant Nagi, PHD study director
Cairo 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 mobile application (little lovely dentist). in people with Anxiety, run by Cairo 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 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 7 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?
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?
Preoperative anxiety (time frame: before administration of local anesthesia during the first dental visit). 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?
On the ClinicalTrials.gov record for NCT04731181, which also lists 9 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 7 Feb 2024.