Behavior, ChildNCT05592587
Pain and Anxiety Reduction Using a Vibrating Eye Massage Device With Relaxing Nature Sounds
A study testing Evaluation of the effectiveness of eye massage device producing both vibrations and nature sounds distraction in the management of anxious pediatric patients during inferior alveolar nerve., Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve. and Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve. in people with Behavior, Child and Dental Anxiety, run by Damascus University at 1 site in Syria.
Trial summary
This study aims to evaluate the effectiveness and acceptance of an eye massage device that produces nature sounds and vibratory stimulations in the management of anxious pediatric patients during inferior alveolar nerve block Group A (Control group): inferior alveolar nerve block will be administrated with basic… Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child, Dental Anxiety, Anesthesia, Local
- What is being tested?
- Evaluation of the effectiveness of eye massage device producing both vibrations and nature sounds distraction in the management of anxious pediatric patients during inferior alveolar nerve., Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve. and Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSyria
- Study dates
- 15 Jun 2022to 25 Jan 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age between 7 and 9 years.
- no previous dental experience.
- definitely positive or positive ratings of Frank scale.
- Need of IAN block for any dental treatment.
Who cannot join
- previous dental experience
- systematic or mental disorders.
- definitely negative or negative ratings of Frankel scale
- Any contraindication for regional anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Acceptance and Efficacy of an Eye Massage Device in Reducing Pain and Anxiety During Dental Anesthesia in Children.
This study aims to evaluate the effectiveness and acceptance of an eye massage device that produces nature sounds and vibratory stimulations in the management of anxious pediatric patients during inferior alveolar nerve block
Group A (Control group): inferior alveolar nerve block will be administrated with basic behavior guidance techniques and without distraction aids.
Read more
Group B: inferior alveolar nerve block will be administrated with the usage of the eye massage device producing both vibrations and nature sounds
Group C: inferior alveolar nerve block will be administrated with the eye massage device producing vibratory stimulations only.
All of the children who experienced an inferior alveolar block with/without distraction will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") Acceptance will be measured using a two-point Likert scale.
Read the detailed description
This study will evaluate the effectiveness and acceptance of a distraction aid that produces both vibratory and natural sound stimulations. pain and anxiety will be assessed during inferior alveolar nerve block using four behavioral scales, Wong-Baker pain scale and Children's Fear Scale (self-report), pulse rate and blood pressure (physiological), and behavior (using FLACC behavior rating scale "external evaluator".
Heart pulse rate measurement will be recorded firstly when the patient is seated comfortably on the dental chair, during anesthesia, and finally, after the procedure is done and the child patients will be asked to choose a face that describes their status from one of both Wong Baker faces scale and Children's Fear Scale.
Blood pressure will be recorded before, during, and after anesthesia. Body responses of all child patients will be recorded during the whole procedure and then will be evaluated by an external evaluator to determine the children's behavioral score according to the FLACC scale.
- Conditions
- Behavior, Child, Dental Anxiety, Anesthesia, Local
- Being tested
- Evaluation of the effectiveness of eye massage device producing both vibrations and nature sounds distraction in the management of anxious pediatric patients during inferior alveolar nerve., Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve., Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve.
- Keywords
- Eye massage device, Vibratory stimulation, Nature sounds, Distraction
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the effectiveness of eye massage device producing both vibrations and nature sounds distraction in the management of anxious pediatric patients during inferior alveolar nerve.Behavioural
The child will be provided inferior alveolar nerve during eye massage device producing both vibrations and nature sounds. Children will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator"). Acceptance will be measured using a two-point Likert scale
Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve.Behavioural
The child will be provided inferior alveolar nerve during eye massage device producing vibratory stimulations. Children will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator"). Acceptance will be measured using a two-point Likert scale
Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve.Behavioural
The child will be provided inferior alveolar nerve during eye massage device producing vibratory stimulations. Children will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator"). Acceptance will be measured using a two-point Likert scale
| Study group | Role | What they receive |
|---|---|---|
| Distraction using eye massage device producing both vibrations and nature sounds. | Experimental | Not described Receives: Behavioral: Evaluation of the effectiveness of eye massage device producing both vibrations and nature sounds distraction in the management of anxious pediatric patients during inferior alveolar nerve. |
| Distraction using eye massage device producing vibratory stimulations only. | Experimental | Not described Receives: Behavioral: Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve. |
| Using basic behavior guidance techniques and without using any type of distraction aids. | Other | Not described Receives: Behavioral: Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain levels
Pain levels will be measured by using a self-reported simplified Wong-Baker faces pain scale:
0 no Hurt - 1 Hurts little Bit - 2 Hurts little More - 3 Hurts Even More - 4 Hurts Whole Lot - 5 Hurts Worst
Measured: 5 minutes following the inferior alveolar nerve block injection.
Anxiety levels
This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale (0 low anxiety and pain level - 10 high anxiety and pain level).
Measured: 1 minute during inferior alveolar nerve block administration.
Anxiety levels
This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety').
Measured: five minutes following the inferior alveolar nerve block injection
Secondary outcomes (2)
Pulse rate
Pulse rate (the number of times your heart beats each minute bpm will be evaluated using Finger Pulse Oximeter.
Measured: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug
Blood pressure
Blood pressure (millimeters of mercury mmHg) will be evaluated using a Wrist Digital Blood Pressure Monitor.
Measured: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start15 Jun 2022
- Primary completion15 Oct 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Behavior, ChildStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dajma Abed, DDs, Principal investigator, Damascus UniversityNada G Bshara, Phd, Study director, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592587
- Sponsor's protocol ID
- UDDS-Pedo-04-2022
- Status last verified
- Feb 2023
- First submitted
- 17 Sep 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crego A, Carrillo-Diaz M, Armfield JM, Romero M. Dental fear and expected effectiveness of destructive coping as predictors of children's uncooperative intentions in dental settings. Int J Paediatr Dent. 2015 May;25(3):191-8. doi: 10.1111/ipd.12126. Epub 2014 Jul 22.
PubMed 25047094Attar RH, Baghdadi ZD. Comparative efficacy of active and passive distraction during restorative treatment in children using an iPad versus audiovisual eyeglasses: a randomised controlled trial. Eur Arch Paediatr Dent. 2015 Feb;16(1):1-8. doi: 10.1007/s40368-014-0136-x. Epub 2014 Nov 22.
PubMed 25416522Buxton RT, Pearson AL, Allou C, Fristrup K, Wittemyer G. A synthesis of health benefits of natural sounds and their distribution in national parks. Proc Natl Acad Sci U S A. 2021 Apr 6;118(14):e2013097118. doi: 10.1073/pnas.2013097118.
PubMed 33753555Canbulat N, Ayhan F, Inal S. Effectiveness of external cold and vibration for procedural pain relief during peripheral intravenous cannulation in pediatric patients. Pain Manag Nurs. 2015 Feb;16(1):33-9. doi: 10.1016/j.pmn.2014.03.003. Epub 2014 Jun 7.
PubMed 24912740Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.
PubMed 26156269
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Acceptance and Efficacy of an Eye Massage Device in Reducing Pain and Anxiety During Dental Anesthesia in Children.
- ClinicalTrials.gov ID
- NCT05592587
- Acronym / sponsor ID
- UDDS-Pedo-04-2022
- Conditions
- Behavior, Child, Dental Anxiety, Anesthesia, Local
- Keywords
- Eye massage device, Vibratory stimulation, Nature sounds, Distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 24 Oct 2022 (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 aims to evaluate the effectiveness and acceptance of an eye massage device that produces nature sounds and vibratory stimulations in the management of anxious pediatric patients during inferior alveolar nerve block
Group A (Control group): inferior alveolar nerve block will be administrated with basic behavior guidance techniques and without distraction aids.
Group B: inferior alveolar nerve block will be administrated with the usage of the eye massage device producing both vibrations and nature sounds
Group C: inferior alveolar nerve block will be administrated with the eye massage device producing vibratory stimulations only.
All of the children who experienced an inferior alveolar block with/without distraction will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") Acceptance will be measured using a two-point Likert scale.
Detailed description
This study will evaluate the effectiveness and acceptance of a distraction aid that produces both vibratory and natural sound stimulations. pain and anxiety will be assessed during inferior alveolar nerve block using four behavioral scales, Wong-Baker pain scale and Children's Fear Scale (self-report), pulse rate and blood pressure (physiological), and behavior (using FLACC behavior rating scale "external evaluator".
Heart pulse rate measurement will be recorded firstly when the patient is seated comfortably on the dental chair, during anesthesia, and finally, after the procedure is done and the child patients will be asked to choose a face that describes their status from one of both Wong Baker faces scale and Children's Fear Scale.
Blood pressure will be recorded before, during, and after anesthesia. Body responses of all child patients will be recorded during the whole procedure and then will be evaluated by an external evaluator to determine the children's behavioral score according to the FLACC scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Distraction using eye massage device producing both vibrations and nature sounds. | Experimental | Behavioral: Evaluation of the effectiveness of eye massage device producing both vibrations and nature sounds distraction in the management of anxious pediatric patients during inferior alveolar nerve. |
| Distraction using eye massage device producing vibratory stimulations only. | Experimental | Behavioral: Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve. |
| Using basic behavior guidance techniques and without using any type of distraction aids. | Other | Behavioral: Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age between 7 and 9 years.
- no previous dental experience.
- definitely positive or positive ratings of Frank scale.
- Need of IAN block for any dental treatment.
Key exclusion criteria (4 listed)
- previous dental experience
- systematic or mental disorders.
- definitely negative or negative ratings of Frankel scale
- Any contraindication for regional anesthesia
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 |
|---|---|---|
| Evaluation of the effectiveness of eye massage device producing both vibrations and nature sounds distraction in the management of anxious pediatric patients during inferior alveolar nerve.The child will be provided inferior alveolar nerve during eye massage device producing both vibrations and nature sounds. Children will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator"). Acceptance will be measured using a two-point Likert scale | Behavioural | Distraction using eye massage device producing both vibrations and nature sounds. |
| Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve.The child will be provided inferior alveolar nerve during eye massage device producing vibratory stimulations. Children will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator"). Acceptance will be measured using a two-point Likert scale | Behavioural | Distraction using eye massage device producing vibratory stimulations only. |
| Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve.The child will be provided inferior alveolar nerve during eye massage device producing vibratory stimulations. Children will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate and blood pressure (physiological), and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator"). Acceptance will be measured using a two-point Likert scale | Behavioural | Using basic behavior guidance techniques and without using any type of distraction aids. |
Primary outcome
Pain levels
Time frame: 5 minutes following the inferior alveolar nerve block injection.
Pain levels will be measured by using a self-reported simplified Wong-Baker faces pain scale: 0 no Hurt - 1 Hurts little Bit - 2 Hurts little More - 3 Hurts Even More - 4 Hurts Whole Lot - 5 Hurts Worst
Anxiety levels
Time frame: 1 minute during inferior alveolar nerve block administration.
This will be evaluated using the Face-Legs-Activity-Cry-Consolability (FLACC) scale (0 low anxiety and pain level - 10 high anxiety and pain level).
Anxiety levels
Time frame: five minutes following the inferior alveolar nerve block injection
This will be evaluated using Children's Fear Scale (0 indicating 'no anxiety' and 4 indicating 'extreme anxiety').
2 secondary outcomes
Pulse rate
Time frame: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug
Blood pressure
Time frame: (1) five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection of the anesthetic drug
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 9 Feb 2023.
- Background: PubMed 25047094Crego A, Carrillo-Diaz M, Armfield JM, Romero M. Dental fear and expected effectiveness of destructive coping as predictors of children's uncooperative intentions in dental settings. Int J Paediatr Dent. 2015 May;25(3):191-8. doi: 10.1111/ipd.12126. Epub 2014 Jul 22.
- Background: PubMed 25416522Attar RH, Baghdadi ZD. Comparative efficacy of active and passive distraction during restorative treatment in children using an iPad versus audiovisual eyeglasses: a randomised controlled trial. Eur Arch Paediatr Dent. 2015 Feb;16(1):1-8. doi: 10.1007/s40368-014-0136-x. Epub 2014 Nov 22.
- Background: PubMed 33753555Buxton RT, Pearson AL, Allou C, Fristrup K, Wittemyer G. A synthesis of health benefits of natural sounds and their distribution in national parks. Proc Natl Acad Sci U S A. 2021 Apr 6;118(14):e2013097118. doi: 10.1073/pnas.2013097118.
- Background: PubMed 24912740Canbulat N, Ayhan F, Inal S. Effectiveness of external cold and vibration for procedural pain relief during peripheral intravenous cannulation in pediatric patients. Pain Manag Nurs. 2015 Feb;16(1):33-9. doi: 10.1016/j.pmn.2014.03.003. Epub 2014 Jun 7.
- Background: PubMed 26156269Shilpapriya M, Jayanthi M, Reddy VN, Sakthivel R, Selvaraju G, Vijayakumar P. Effectiveness of new vibration delivery system on pain associated with injection of local anesthesia in children. J Indian Soc Pedod Prev Dent. 2015 Jul-Sep;33(3):173-6. doi: 10.4103/0970-4388.160343.
- Individual participant dataSharing planned: No
Related trials for Behavior, Child
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Pregnancy 24/7 Offspring Study
Healthy
Recruiting
Sibling Caregiver CMC Pilot Study
Children With Medical Complexity (CMC), Siblings
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
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.
Dajma Abed, DDs principal investigator
Damascus University
Nada G Bshara, Phd study director
Damascus 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 Evaluation of the effectiveness of eye massage device producing both vibrations and nature sounds distraction in the management of anxious pediatric patients during inferior alveolar nerve., Evaluation of the effectiveness of eye massage device producing vibratory stimulations distraction in the management of anxious pediatric patients during inferior alveolar nerve. and Evaluation of the effectiveness of basic behavior guidance techniques without using any type of distraction aids in the management of anxious pediatric patients during inferior alveolar nerve. in people with Behavior, Child and Dental Anxiety, run by Damascus University at 1 site in Syria.
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 4 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 9 Feb 2023. 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 Syria. 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?
Pain levels (time frame: 5 minutes following the inferior alveolar nerve block injection.). 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?
On the ClinicalTrials.gov record for NCT05592587, which also lists 5 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 9 Feb 2023.