Dental AnxietyNCT05759286
A Blend of Lavender-neroli Oils Aromatherapy and Music for Managing Anxiety in a Pediatric Patient
A study testing Aromatherapy and Music in people with Dental Anxiety, run by Damascus University at 1 site in Syria.
Trial summary
The study sample will be divided randomly into 4 groups, each group will contain 27 children who need treatment in mandibular teeth and require anesthesia with inferior alveolar nerve block which is considered a painful procedure. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Aromatherapy and Music
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSyria
- Study dates
- 15 Sep 2021to 20 Jun 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1) 6-11 age children
- 2)children category 2,3 on Frankle behavior rating scale,
- 3) need treatment in mandibular molars to need anesthesia with IANB injection
Who cannot join
- 1) children with the mental or systematic disease
- 2) with a history of allergy, asthma, or have influenza
- 3)having a hearing problem or refusing to listen to music
Trial locations and contacts
1 site in 1 country.
Syria1 site
College of Dentistry
Damascus, Al-Mazzeh Saint, Damascus P.O.Box 3062
About this study
Official title: Effect of Aromatherapy Using Lavender- Neroli Oils Blend and Music in the Management of Dental Anxiety in Children
The study sample will be divided randomly into 4 groups, each group will contain 27 children who need treatment in mandibular teeth and require anesthesia with inferior alveolar nerve block which is considered a painful procedure.
In the aromatherapy group, 3 drops of lavender-Neroli will be applied to cotton balls, which will be placed in a box designed with 3D printing to be placed on the nasal mask that is similar to the one used when administering nitrous oxide, so that the child inhales the aroma of the essential oil through the nasal mask. The mask is applied 5 minutes before administering local anesthesia in order to allow the child to inhale the oil aroma prior to and during local anesthesia.
Read more
In the music group, the music will be played from the recorder prior to local anesthesia and during it, music will be chosen by the child from the cartoon movies/tv shows they watch so that it is from his environment and familiar to them.
In The third group, both music and aromatherapy will drive the anesthesia process.
In The control groups, the child will put on the same nasal mask without an aromatherapy box to obtain a placebo effect and then receive the anesthesia.
Read the detailed description
The sample of this study were children attending the department of pediatric dentistry faculty of dentistry, Damascus university, who need treatment in the mandibular teeth with an IANB injection After taking informed consent from the parent, the children were divided into 4 groups: aromatherapy intervention, music intervention, both aroma, and music intervention, and control groups
In the aromatherapy group:
firstly the essential oils were obtained from Biocham Natural Extracts co, Damascus, Syria(100%pure lavender (L.angustifolia), 100% pure Neroli (C. aranium)) and the main components of the oils were determined by gas chromatography, which was found to be 47% linalool acetate in lavender oil, and 37% linalool 9% limonene in Neroli oil Then A 15% lavender-Neroli oil was prepared by blending 2.3 ml lavender oil with 0.9 ml Neroli oil and diluting with grape seed oil to 20 ml which was done in the department of pharmacognosy, Faculty of pharmacy Damascus university In the dental treatment, A child will be allowed to inhale the aromatic scent of the oil blend through a cylindrical box which is 3D printed and contains cavities inside it and perforated from its upper and lower surface. It will be applied to the circular hole of the mask which is similar to the one that uses when supplying nitrous oxide. so that this box allows for safer aromatherapy, as it can be removed in the event of any allergy symptoms appearing on the child and provide him oxygen through the mask.
3 drops of 15%lavender-Neroli blend were poured on cotton balls and then put on the aroma box, the box then was placed on the mask which was applied to the child's nose, so that the child inhales the scent of the aromatic blend through the holes in the bottom of the box, which faces the child's nose.
The children were asked to inhale the aromatic oils blend 5 minutes before intervention and during needle insertion when administrating IANB injection.
In the music group:
The child asks to choose a song from their cartoons and program to make it familiar to them and desirable and then listen to it through a recorder So that the music is heard as a background in the environment surrounding the work to avoid isolating the child from his environment and the ability to continue audio communication between the doctor and the child.
The songs will play 5 minutes before and during needle administrating. In the combination group: aromatherapy and music were used above In the control group: the children who received IANB injection-s will be treated with child behavior management like tell-show-do and the nitrous oxide nasal mask was used without the box which was used to carry inside it the scent of the aromatic oils blend to obtain a placebo effect.
The child's anxiety level would be assessed through FLACC, Facial image scale, heart rate, systolic, Diastolic blood pressure, and respiratory saturation before and after injection.
The IANB injection was performed using a 27-gauge needle and a local anesthetic of 2% lidocaine with 1:100,000 epinephrine by one researcher.
- Conditions
- Dental Anxiety
- Being tested
- Aromatherapy, Music, Control
- Keywords
- aromatherapy, music, lavender, neroli, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyBehavioural
Aroma therapy will apply before 5 minutes and during IANB injection in children, aromatherapy will apply through a nasal mask similar to one that uses when applying nitrous oxide after putting a 3d printed perforated box on the mask's circular halo on its surface, in this box cotton bolls impregnated with 3 drops of a 15% lavender-neroli oils blend are placed and then the child will smell the scent of aromatic oil blend from the box's perforated bottom surface which faces child's nose
MusicBehavioural
Music will be played from a speaker in the treatment environment and will start 5 minutes before anesthesia and will be played through the whole anesthesia process, the music used will be chosen by the child from his favourite cartoon
ControlBehavioural
Also called Placebo
using a tell-show-do approach and children will put on a nasal mask without the box that contains an aromatic oil blend for the placebo effect
| Study group | Role | What they receive |
|---|---|---|
| aromatherapy group | Experimental | Children in this group will receive IANB injection with a nasal mask (similar to a nitrous oxide mask), the way the mask work is by putting on its circular hole a 3d printed perforated box containing cotton balls loaded with lavender-neroli oils blend Receives: Behavioral: Aromatherapy |
| music group | Experimental | children in this group will receive IANB injections by listening to music as background from a recorder. Receives: Behavioral: Music |
| combination group music and aromatherapy | Experimental | children in this group will receive aromatherapy using the nasal mask with an aromatherapy box as well as music for 5 minutes and through the injection Receives: Behavioral: Aromatherapy; Behavioral: Music |
| control group | Other | children in this group will receive IANB injections with behavioral management techniques l Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self report anxiety assessment
5 faces rang from very happy to very sad, one point is given to the most postive face and 5 point gives to the most negative face
Measured: directly 1second after anesthesia administration
Observation pain assessment
Face, Legs, Activity, Cry, Consolability(FLACC), it has five categories of behavior to assess pain, namely , facial expression, leg movement, activity, cry, and Consolability, the score of each category are between 0and 2, the total score can rang from 0 to 10, defined as mild(1-3), moderate (4-6), and severe (7-10). for each patient, FLACC would be assess through video recorded during administration the IANB injection and then were evaluated by an external evaluator to determine the children behavior score according to this scale
Measured: 5 second from starting the anesthesia
Secondary outcomes (4)
change in diastolic blood pressure
digital blood pressure monitor will be placed in the child's left elbow and the difference between the reading 5 minutes before anesthesia and after 20 sec from it
Measured: 5 minutes before anesthesia/20 second after anesthesia
change in systolic blood pressure
digital blood pressure monitor will be placed in the child's left elbow and the difference between the reading 5 minutes before anesthesia and after 20 sec from it
Measured: 5 minutes before anesthesia/20 second after anesthesia
change in pulse rate
an oximeter will be placed on the finger of the left hand and the difference between the pulse reading 5 minutes before anesthesia and 20 sec after it
Measured: 5 minutes before anesthesia/20second after anesthesia
change in O2 saturation
an oximeter will be placed on the finger of the left hand and the difference between the saturation reading 5 minutes before anesthesia and 20 sec after it
Measured: 5 minutes before anesthesia/20 second after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start15 Sep 2021
- Primary completion20 Mar 2022
- Study completion20 Jun 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 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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chaza Kouchaji, Professor, Study director, SupervisalRasha Al-khatib, professor, Study director, Co- supervisal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759286
- Sponsor's protocol ID
- UDDS-Pedo-01-2023
- Status last verified
- Nov 2025
- First submitted
- 8 Feb 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ainscough SL, Windsor L, Tahmassebi JF. A review of the effect of music on dental anxiety in children. Eur Arch Paediatr Dent. 2019 Feb;20(1):23-26. doi: 10.1007/s40368-018-0380-6. Epub 2018 Oct 29.
PubMed 30374854Agatonovic-Kustrin S, Kustrin E, Gegechkori V, Morton DW. Anxiolytic Terpenoids and Aromatherapy for Anxiety and Depression. Adv Exp Med Biol. 2020;1260:283-296. doi: 10.1007/978-3-030-42667-5_11.
PubMed 32304038Arslan I, Aydinoglu S, Karan NB. Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial. Eur J Pediatr. 2020 Jun;179(6):985-992. doi: 10.1007/s00431-020-03595-7. Epub 2020 Feb 6.
PubMed 32030454Bradt J, Teague A. Music interventions for dental anxiety. Oral Dis. 2018 Apr;24(3):300-306. doi: 10.1111/odi.12615. Epub 2017 Jan 5.
PubMed 27886431Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Epub 2020 Sep 9.
PubMed 33245591Morgan AG, Rodd HD, Porritt JM, Baker SR, Creswell C, Newton T, Williams C, Marshman Z. Children's experiences of dental anxiety. Int J Paediatr Dent. 2017 Mar;27(2):87-97. doi: 10.1111/ipd.12238. Epub 2016 Jul 4.
PubMed 27376925Zhang N, Yao L. Anxiolytic Effect of Essential Oils and Their Constituents: A Review. J Agric Food Chem. 2019 Dec 18;67(50):13790-13808. doi: 10.1021/acs.jafc.9b00433. Epub 2019 Jun 13.
PubMed 31148444Suntar I, Khan H, Patel S, Celano R, Rastrelli L. An Overview on Citrus aurantium L.: Its Functions as Food Ingredient and Therapeutic Agent. Oxid Med Cell Longev. 2018 May 2;2018:7864269. doi: 10.1155/2018/7864269. eCollection 2018.
PubMed 29854097Ota M, Sato N, Sone D, Ogura J, Kunugi H. (-)-Linalool influence on the cerebral blood flow in healthy male volunteers revealed by three-dimensional pseudo-continuous arterial spin labeling. Indian J Psychiatry. 2017 Apr-Jun;59(2):225-227. doi: 10.4103/psychiatry.IndianJPsychiatry_323_16.
PubMed 28827872
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aromatherapy Using Lavender- Neroli Oils Blend and Music in the Management of Dental Anxiety in Children
- ClinicalTrials.gov ID
- NCT05759286
- Acronym / sponsor ID
- UDDS-Pedo-01-2023
- Conditions
- Dental Anxiety
- Keywords
- aromatherapy, music, lavender, neroli, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 8 Mar 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.
The study sample will be divided randomly into 4 groups, each group will contain 27 children who need treatment in mandibular teeth and require anesthesia with inferior alveolar nerve block which is considered a painful procedure.
In the aromatherapy group, 3 drops of lavender-Neroli will be applied to cotton balls, which will be placed in a box designed with 3D printing to be placed on the nasal mask that is similar to the one used when administering nitrous oxide, so that the child inhales the aroma of the essential oil through the nasal mask. The mask is applied 5 minutes before administering local anesthesia in order to allow the child to inhale the oil aroma prior to and during local anesthesia.
In the music group, the music will be played from the recorder prior to local anesthesia and during it, music will be chosen by the child from the cartoon movies/tv shows they watch so that it is from his environment and familiar to them.
In The third group, both music and aromatherapy will drive the anesthesia process.
In The control groups, the child will put on the same nasal mask without an aromatherapy box to obtain a placebo effect and then receive the anesthesia.
Detailed description
The sample of this study were children attending the department of pediatric dentistry faculty of dentistry, Damascus university, who need treatment in the mandibular teeth with an IANB injection After taking informed consent from the parent, the children were divided into 4 groups: aromatherapy intervention, music intervention, both aroma, and music intervention, and control groups
In the aromatherapy group:
firstly the essential oils were obtained from Biocham Natural Extracts co, Damascus, Syria(100%pure lavender (L.angustifolia), 100% pure Neroli (C. aranium)) and the main components of the oils were determined by gas chromatography, which was found to be 47% linalool acetate in lavender oil, and 37% linalool 9% limonene in Neroli oil Then A 15% lavender-Neroli oil was prepared by blending 2.3 ml lavender oil with 0.9 ml Neroli oil and diluting with grape seed oil to 20 ml which was done in the department of pharmacognosy, Faculty of pharmacy Damascus university In the dental treatment, A child will be allowed to inhale the aromatic scent of the oil blend through a cylindrical box which is 3D printed and contains cavities inside it and perforated from its upper and lower surface. It will be applied to the circular hole of the mask which is similar to the one that uses when supplying nitrous oxide. so that this box allows for safer aromatherapy, as it can be removed in the event of any allergy symptoms appearing on the child and provide him oxygen through the mask.
3 drops of 15%lavender-Neroli blend were poured on cotton balls and then put on the aroma box, the box then was placed on the mask which was applied to the child's nose, so that the child inhales the scent of the aromatic blend through the holes in the bottom of the box, which faces the child's nose.
The children were asked to inhale the aromatic oils blend 5 minutes before intervention and during needle insertion when administrating IANB injection.
In the music group:
The child asks to choose a song from their cartoons and program to make it familiar to them and desirable and then listen to it through a recorder So that the music is heard as a background in the environment surrounding the work to avoid isolating the child from his environment and the ability to continue audio communication between the doctor and the child.
The songs will play 5 minutes before and during needle administrating. In the combination group: aromatherapy and music were used above In the control group: the children who received IANB injection-s will be treated with child behavior management like tell-show-do and the nitrous oxide nasal mask was used without the box which was used to carry inside it the scent of the aromatic oils blend to obtain a placebo effect.
The child's anxiety level would be assessed through FLACC, Facial image scale, heart rate, systolic, Diastolic blood pressure, and respiratory saturation before and after injection.
The IANB injection was performed using a 27-gauge needle and a local anesthetic of 2% lidocaine with 1:100,000 epinephrine by one researcher.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| aromatherapy group | Experimental | Behavioral: AromatherapyChildren in this group will receive IANB injection with a nasal mask (similar to a nitrous oxide mask), the way the mask work is by putting on its circular hole a 3d printed perforated box containing cotton balls loaded with lavender-neroli oils blend |
| music group | Experimental | Behavioral: Musicchildren in this group will receive IANB injections by listening to music as background from a recorder. |
| combination group music and aromatherapy | Experimental | Behavioral: Aromatherapy, Behavioral: Musicchildren in this group will receive aromatherapy using the nasal mask with an aromatherapy box as well as music for 5 minutes and through the injection |
| control group | Other | Behavioral: Controlchildren in this group will receive IANB injections with behavioral management techniques l |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1) 6-11 age children
- 2)children category 2,3 on Frankle behavior rating scale,
- 3) need treatment in mandibular molars to need anesthesia with IANB injection
Key exclusion criteria (3 listed)
- 1) children with the mental or systematic disease
- 2) with a history of allergy, asthma, or have influenza
- 3)having a hearing problem or refusing to listen to music
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 |
|---|---|---|
| AromatherapyAroma therapy will apply before 5 minutes and during IANB injection in children, aromatherapy will apply through a nasal mask similar to one that uses when applying nitrous oxide after putting a 3d printed perforated box on the mask's circular halo on its surface, in this box cotton bolls impregnated with 3 drops of a 15% lavender-neroli oils blend are placed and then the child will smell the scent of aromatic oil blend from the box's perforated bottom surface which faces child's nose | Behavioural | aromatherapy group, combination group music and aromatherapy |
| MusicMusic will be played from a speaker in the treatment environment and will start 5 minutes before anesthesia and will be played through the whole anesthesia process, the music used will be chosen by the child from his favourite cartoon | Behavioural | combination group music and aromatherapy, music group |
| ControlAlso: Placebousing a tell-show-do approach and children will put on a nasal mask without the box that contains an aromatic oil blend for the placebo effect | Behavioural | control group |
Primary outcome
Self report anxiety assessment
Time frame: directly 1second after anesthesia administration
5 faces rang from very happy to very sad, one point is given to the most postive face and 5 point gives to the most negative face
Observation pain assessment
Time frame: 5 second from starting the anesthesia
Face, Legs, Activity, Cry, Consolability(FLACC), it has five categories of behavior to assess pain, namely , facial expression, leg movement, activity, cry, and Consolability, the score of each category are between 0and 2, the total score can rang from 0 to 10, defined as mild(1-3), moderate (4-6), and severe (7-10). for each patient, FLACC would be assess through video recorded during administration the IANB injection and then were evaluated by an external evaluator to determine the children behavior score according to this scale
4 secondary outcomes
change in diastolic blood pressure
Time frame: 5 minutes before anesthesia/20 second after anesthesia
change in systolic blood pressure
Time frame: 5 minutes before anesthesia/20 second after anesthesia
change in pulse rate
Time frame: 5 minutes before anesthesia/20second after anesthesia
change in O2 saturation
Time frame: 5 minutes before anesthesia/20 second after anesthesia
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 18 Nov 2025.
- Background: PubMed 30374854Ainscough SL, Windsor L, Tahmassebi JF. A review of the effect of music on dental anxiety in children. Eur Arch Paediatr Dent. 2019 Feb;20(1):23-26. doi: 10.1007/s40368-018-0380-6. Epub 2018 Oct 29.
- Background: PubMed 32304038Agatonovic-Kustrin S, Kustrin E, Gegechkori V, Morton DW. Anxiolytic Terpenoids and Aromatherapy for Anxiety and Depression. Adv Exp Med Biol. 2020;1260:283-296. doi: 10.1007/978-3-030-42667-5_11.
- Background: PubMed 32030454Arslan I, Aydinoglu S, Karan NB. Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial. Eur J Pediatr. 2020 Jun;179(6):985-992. doi: 10.1007/s00431-020-03595-7. Epub 2020 Feb 6.
- Background: PubMed 27886431Bradt J, Teague A. Music interventions for dental anxiety. Oral Dis. 2018 Apr;24(3):300-306. doi: 10.1111/odi.12615. Epub 2017 Jan 5.
- Background: PubMed 33245591Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Epub 2020 Sep 9.
- Background: PubMed 27376925Morgan AG, Rodd HD, Porritt JM, Baker SR, Creswell C, Newton T, Williams C, Marshman Z. Children's experiences of dental anxiety. Int J Paediatr Dent. 2017 Mar;27(2):87-97. doi: 10.1111/ipd.12238. Epub 2016 Jul 4.
- Background: PubMed 31148444Zhang N, Yao L. Anxiolytic Effect of Essential Oils and Their Constituents: A Review. J Agric Food Chem. 2019 Dec 18;67(50):13790-13808. doi: 10.1021/acs.jafc.9b00433. Epub 2019 Jun 13.
- Background: PubMed 29854097Suntar I, Khan H, Patel S, Celano R, Rastrelli L. An Overview on Citrus aurantium L.: Its Functions as Food Ingredient and Therapeutic Agent. Oxid Med Cell Longev. 2018 May 2;2018:7864269. doi: 10.1155/2018/7864269. eCollection 2018.
- Background: PubMed 28827872Ota M, Sato N, Sone D, Ogura J, Kunugi H. (-)-Linalool influence on the cerebral blood flow in healthy male volunteers revealed by three-dimensional pseudo-continuous arterial spin labeling. Indian J Psychiatry. 2017 Apr-Jun;59(2):225-227. doi: 10.4103/psychiatry.IndianJPsychiatry_323_16.
- Individual participant dataSharing planned: No
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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.
Chaza Kouchaji, Professor study director
Supervisal
Rasha Al-khatib, professor study director
Co- supervisal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Music in people with 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 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: finished, as of the sponsor's last update on 18 Nov 2025. 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?
Self report anxiety assessment (time frame: directly 1second after anesthesia administration). The study lists 2 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 NCT05759286, 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 18 Nov 2025.