Dental AnxietyNCT03923088
Comparison Between Jacobson's Progressive Muscle Relaxation Technique and Audio-visual Distraction Technique in Reducing Dental Anxiety in Children During Dental Visit
A study testing jacobson's progressive muscle relaxation technique and audio-visual distraction technique in people with Dental Anxiety, run by Dina Hussien Abdelhafez.
Trial summary
Dental anxiety is fear associated with the thought of visiting the dentist for preventive care and dental procedures. Children with dental anxiety characterized by crying before dental checkup, tachycardia and aggressively clinging to the accompanying parent. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- jacobson's progressive muscle relaxation technique and audio-visual distraction technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children: 6 to 9 years old children. Teeth: tooth requiring dental treatment
Who cannot join
- Children having allergy to local anaesthesia or systemic problem. Refusal of participation Mentally ill or mentally retarded children
About this study
Official title: Comparison Between Jacobson's Progressive Muscle Relaxation Technique and Audio-visual Distraction Technique in Reducing Dental Anxiety in Children During Dental Visit ; Randomized Clinical Trial
Dental anxiety is fear associated with the thought of visiting the dentist for preventive care and dental procedures. Children with dental anxiety characterized by crying before dental checkup, tachycardia and aggressively clinging to the accompanying parent. It has been cited as the fifthmost common cause of anxiety by Agras et al. Dental anxiety may have major and long-lasting implications for the child and their family. Cohen et al reported that dental anxiety affects an individual's life in multiple ways. The physiological impacts included signs and symptoms of the fright response and feelings of exhaustion after a dental appointment, while the cognitive impacts included an array of negative thoughts, beliefs, and fears. Dental anxiety in children could remain a problem in adulthood if not handled properly thus it will affect oral health and psycho-social condition. This research is conducted to deliver different concepts in psychological and behavioral techniques in management of anxious pediatric dental patients.
- Conditions
- Dental Anxiety
- Being tested
- jacobson's progressive muscle relaxation technique, audio-visual distraction technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
jacobson's progressive muscle relaxation techniqueBehavioural
This involves tensing specific muscle groups for 5-7 seconds, followed by 20 seconds of relaxation. The method can be demonstrated chairside, and should be practiced and rehearsed by the patient at home. Four major muscle groups are commonly tensed and relaxed. These are: 1) feet, calves, thighs, and buttocks; 2) hands, forearms, and biceps; 3) chest, stomach, and lower back; and 4) head, face, throat, and shoulders
audio-visual distraction techniqueBehavioural
audiovisual distraction not only leads to full involvement of scenes (visual and auditory), but it also induces a positive emotional reaction resulting in a relaxed experience.
| Study group | Role | What they receive |
|---|---|---|
| jacobson's progressive muscle relaxation technique | Experimental | Not described Receives: Behavioral: jacobson's progressive muscle relaxation technique |
| audiovisual distraction technique | Experimental | Not described Receives: Behavioral: audio-visual distraction technique |
| conventional | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cooperation measured by modified venham rating scale
Modified Venham rating scale provides details of positive and negative child's behavior. The scale ranges from total cooperation (0) to no cooperation (5)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study startJun 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dina Hussien Abdelhafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dina Hussien Abdelhafez, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923088
- Sponsor's protocol ID
- 01234
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Jacobson's Progressive Muscle Relaxation Technique and Audio-visual Distraction Technique in Reducing Dental Anxiety in Children During Dental Visit ; Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03923088
- Acronym / sponsor ID
- 01234
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dina Hussien AbdelhafezUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 22 Apr 2019 (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.
Dental anxiety is fear associated with the thought of visiting the dentist for preventive care and dental procedures. Children with dental anxiety characterized by crying before dental checkup, tachycardia and aggressively clinging to the accompanying parent. It has been cited as the fifthmost common cause of anxiety by Agras et al. Dental anxiety may have major and long-lasting implications for the child and their family. Cohen et al reported that dental anxiety affects an individual's life in multiple ways. The physiological impacts included signs and symptoms of the fright response and feelings of exhaustion after a dental appointment, while the cognitive impacts included an array of negative thoughts, beliefs, and fears. Dental anxiety in children could remain a problem in adulthood if not handled properly thus it will affect oral health and psycho-social condition. This research is conducted to deliver different concepts in psychological and behavioral techniques in management of anxious pediatric dental patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| jacobson's progressive muscle relaxation technique | Experimental | Behavioral: jacobson's progressive muscle relaxation technique |
| audiovisual distraction technique | Experimental | Behavioral: audio-visual distraction technique |
| conventional | No intervention | – |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children: 6 to 9 years old children. Teeth: tooth requiring dental treatment
Key exclusion criteria (1 listed)
- Children having allergy to local anaesthesia or systemic problem. Refusal of participation Mentally ill or mentally retarded children
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 |
|---|---|---|
| jacobson's progressive muscle relaxation techniqueThis involves tensing specific muscle groups for 5-7 seconds, followed by 20 seconds of relaxation. The method can be demonstrated chairside, and should be practiced and rehearsed by the patient at home. Four major muscle groups are commonly tensed and relaxed. These are: 1) feet, calves, thighs, and buttocks; 2) hands, forearms, and biceps; 3) chest, stomach, and lower back; and 4) head, face, throat, and shoulders | Behavioural | jacobson's progressive muscle relaxation technique |
| audio-visual distraction techniqueaudiovisual distraction not only leads to full involvement of scenes (visual and auditory), but it also induces a positive emotional reaction resulting in a relaxed experience. | Behavioural | audiovisual distraction technique |
Primary outcome
cooperation measured by modified venham rating scale
Time frame: 1 hour
Modified Venham rating scale provides details of positive and negative child's behavior. The scale ranges from total cooperation (0) to no cooperation (5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing jacobson's progressive muscle relaxation technique and audio-visual distraction technique in people with Dental Anxiety, run by Dina Hussien Abdelhafez.
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 1 inclusion and 1 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 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
cooperation measured by modified venham rating scale (time frame: 1 hour). 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 22 Apr 2019.