Dental AnxietyNCT06153823
Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure
A study testing virtual reality glasses and Tell Show and Do in people with Dental Anxiety, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
To evaluate the impact of using virtual reality glasses using sign language as a distraction method to reduce the dental anxiety in moderate to severe hearing-impaired children compared to the conventional behavior management technique during pulpotomy treatment. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- virtual reality glasses and Tell Show and Do
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Mar 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with Frankl behavior rating score 2 or 3.
- Children requiring pulpotomy in one of their primary molars.
- Parents who accepted to give their consent and participate in the study.
Who cannot join
- Children with any medical condition other than hearing disability (ASA II, III \& IV).
- Syndromic children with hearing impairment.
- Children with previous bad dental experience.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Dentistry
Alexandria
Reem MS Shehata, MS, r.shehata.dent.pg@alexu.edu.eg
Reem MS Shehata, BDS
About this study
Official title: Effectiveness of Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure (Randomized Controlled Clinical Trial)
To evaluate the impact of using virtual reality glasses using sign language as a distraction method to reduce the dental anxiety in moderate to severe hearing-impaired children compared to the conventional behavior management technique during pulpotomy treatment.
The study will be a randomized controlled parallel two arms clinical trial, a total of 40 healthy children aged 5-7 years with moderate to severe hearing disability, will be selected from Pediatric Dentistry and dental public health Department, Faculty of Dentistry, Alexandria University, Egypt. Children selected should have at least one primary molar indicated for pulpotomy. The eligible participants will be randomly assigned to one of two groups: the study group, which will use virtual reality glasses with sign language as a distraction method to manage children's behavior, and the control group, which will use the conventional behavior management strategies including show-tell-do, and positive reinforcement. Local anesthesia will be given and pulpotomy procedure will be done on the selected tooth followed by stainless steel crown restoration. Pre and post-operative assessment of child's dental anxiety will be done using three methods: physiologically using pulse oximeter for measuring the heart rate, objectively using Venham clinical anxiety rating scale, and subjectively using the modified facial image scale.
- Conditions
- Dental Anxiety
- Being tested
- virtual reality glasses, Tell Show and Do
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesOther
child behavior management will be done by using VR glasses distraction
Tell Show and DoOther
child behavior management will be done by using tell show and do technique
| Study group | Role | What they receive |
|---|---|---|
| virtual reality glasses | Experimental | Not described Receives: Other: virtual reality glasses |
| show-tell-do technique. | Active comparator | Not described Receives: Other: Tell Show and Do |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child anxiety level
This objective measure scores the child's level of anxiety with a correlating behavior description It consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact.
Measured: up to 2 months
Secondary outcomes (2)
Change in heart rate
Heart rate (HR) is a physiological sign of pain. It will be measured using a pulse oximeter
Measured: up to 2 months
Change in child anxiety level by subjective method
A modified face scale will be used to subjectively record anxiety . It consists of three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Oct 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153823
- Sponsor's protocol ID
- 0665-04/2023
- Status last verified
- Nov 2023
- First submitted
- 11 Nov 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salama RM, El-Habashy LM, Zeitoun SI. Effectiveness of virtual reality glasses with integrated sign language in reducing dental anxiety during pulpotomy in children with hearing impairment: a randomized controlled trial. BMC Oral Health. 2024 Nov 15;24(1):1388. doi: 10.1186/s12903-024-05129-1.
PubMed 39548423
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06153823
- Acronym / sponsor ID
- 0665-04/2023
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 1 Dec 2023 (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 impact of using virtual reality glasses using sign language as a distraction method to reduce the dental anxiety in moderate to severe hearing-impaired children compared to the conventional behavior management technique during pulpotomy treatment.
The study will be a randomized controlled parallel two arms clinical trial, a total of 40 healthy children aged 5-7 years with moderate to severe hearing disability, will be selected from Pediatric Dentistry and dental public health Department, Faculty of Dentistry, Alexandria University, Egypt. Children selected should have at least one primary molar indicated for pulpotomy. The eligible participants will be randomly assigned to one of two groups: the study group, which will use virtual reality glasses with sign language as a distraction method to manage children's behavior, and the control group, which will use the conventional behavior management strategies including show-tell-do, and positive reinforcement. Local anesthesia will be given and pulpotomy procedure will be done on the selected tooth followed by stainless steel crown restoration. Pre and post-operative assessment of child's dental anxiety will be done using three methods: physiologically using pulse oximeter for measuring the heart rate, objectively using Venham clinical anxiety rating scale, and subjectively using the modified facial image scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality glasses | Experimental | Other: virtual reality glasses |
| show-tell-do technique. | Active comparator | Other: Tell Show and Do |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with Frankl behavior rating score 2 or 3.
- Children requiring pulpotomy in one of their primary molars.
- Parents who accepted to give their consent and participate in the study.
Key exclusion criteria (3 listed)
- Children with any medical condition other than hearing disability (ASA II, III \& IV).
- Syndromic children with hearing impairment.
- Children with previous bad dental experience.
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 |
|---|---|---|
| virtual reality glasseschild behavior management will be done by using VR glasses distraction | Other | virtual reality glasses |
| Tell Show and Dochild behavior management will be done by using tell show and do technique | Other | show-tell-do technique. |
Primary outcome
Change in child anxiety level
Time frame: up to 2 months
This objective measure scores the child's level of anxiety with a correlating behavior description It consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact.
2 secondary outcomes
Change in heart rate
Time frame: up to 2 months
Change in child anxiety level by subjective method
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 39548423Salama RM, El-Habashy LM, Zeitoun SI. Effectiveness of virtual reality glasses with integrated sign language in reducing dental anxiety during pulpotomy in children with hearing impairment: a randomized controlled trial. BMC Oral Health. 2024 Nov 15;24(1):1388. doi: 10.1186/s12903-024-05129-1.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses and Tell Show and Do in people with Dental Anxiety, run by Hams Hamed Abdelrahman 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 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: status not confirmed, as of the sponsor's last update on 1 Dec 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 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?
Contact Reem MS Shehata, BDS (01223172660, r.shehata.dent.pg@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child anxiety level (time frame: up to 2 months). 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 NCT06153823, which also lists 1 linked publication.
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 1 Dec 2023.