AromatherapyNCT06063512
The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain
A study testing sweet orange oil inhalation in people with Aromatherapy, run by Cairo University.
Trial summary
Aim of the study To evaluate the effectiveness of sweet orange oil inhalation in reducing dental anxiety and pain in children undergoing local anaesthetic administration. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Aromatherapy
- What is being tested?
- sweet orange oil inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Aug 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Children classified with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.
- Children aged 8-12 years.
- Patients who need maxillary infiltration anaesthesia in the first dental visit.
Who cannot join
- Children with any neurological or psychological disorders.
- Children with previous LA administration.
- Presence of dental or medical emergency.
- Presence of systemic disorders.
- Chidren with common cold.
- Children with known allergy to topical or local anesthetic agents.
- Parental refusal for participation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anaesthetic Administration: A Randomized Clinical Trial
Aim of the study To evaluate the effectiveness of sweet orange oil inhalation in reducing dental anxiety and pain in children undergoing local anaesthetic administration.
Read the detailed description
Research Question:
Can sweet orange oil help to overcome dental anxiety and pain in children undergoing local anaesthetic administration?
PICO approach:
- P: Children 8 to 12 years old need dental treatment under local anesthesia.
- I: Sweet Orange oil inhalation.
- C: Without aromatherapy.
- O:
Primary Outcome Dental Anxiety Modified Child Dental Anxiety Scale - Faces version [MCDAS(f)-simplified] Pulse rate
Secondary Outcome
Pain Wong-Baker pain rating scale (WBS)
- Conditions
- Aromatherapy
- Being tested
- sweet orange oil inhalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sweet orange oil inhalationOther
sweet orange oil with inhalers will be carried out in an open clinical setting. Three drops of sweet orange oil will be dispensed into a cotton wick of the inhaler, The children will be asked to inhale the aroma from the inhalers for 2 minutes followed by an induction period of 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A (sweet orange oil group) | Experimental | Aromatherapy with inhalers will be carried out in an open clinical setting. Three drops of sweet orange oil will be dispensed into a cotton wick of the inhaler, The children will be asked to inhale the aroma from the inhalers for 2 minutes followed by an induction period of 15 minutes. Receives: Other: sweet orange oil inhalation |
| For Group B (Control Group) | No intervention | No aromatherapy inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Pulse rate
Measured: Through study completion , within 10 months
Anxiety
Modified child dental anxiety scale
Measured: Through study completion , within 10 months
Secondary outcomes (1)
Dental pain
Wong Baker pain rating scale
Measured: Through study completion , within 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study startSep 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionAug 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 AromatherapyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The two parallel groups will receive the maxillary anaesthesia injection by the same operator. In the pre-operative period, MCDAS(f), a self-report measure of anxiety will be recorded for all the children. Measuring preoperative dental anxiety (expressed by heart rate) using pulse oximeter For Group A (sweet orange oil group): Aromatherapy with inhalers will be carried out, The children will be asked to inhale the aroma from the inhaler For Group B (Control Group): No aromatherapy inhalation . Administration of topical anesthesia . Administration of local anesthesia . After LA administration, Wong-Baker pain rating scale (WBS) will be recorded as a self report measure of pain for all the children. After LA administration, anxiety will be recorded again using MCDAS(f) for all the children. Measuring postoperative dental anxiety (expressed by heart rate ) using pulse oximeter.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Abdel Azim Abdel Wahab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063512
- Sponsor's protocol ID
- aromatherapy in dentistry
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nirmala K, Kamatham R. Effect of Aromatherapy on Dental Anxiety and Pain in Children Undergoing Local Anesthetic Administrations: A Randomized Clinical Trial. J Caring Sci. 2021 Aug 23;10(3):111-120. doi: 10.34172/jcs.2021.026. eCollection 2021 Aug.
PubMed 34849354
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anaesthetic Administration: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06063512
- Acronym / sponsor ID
- aromatherapy in dentistry
- Conditions
- Aromatherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 2 Oct 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.
Aim of the study To evaluate the effectiveness of sweet orange oil inhalation in reducing dental anxiety and pain in children undergoing local anaesthetic administration.
Detailed description
Research Question:
Can sweet orange oil help to overcome dental anxiety and pain in children undergoing local anaesthetic administration?
PICO approach:
- P: Children 8 to 12 years old need dental treatment under local anesthesia.
- I: Sweet Orange oil inhalation.
- C: Without aromatherapy.
- O:
Primary Outcome Dental Anxiety Modified Child Dental Anxiety Scale - Faces version [MCDAS(f)-simplified] Pulse rate
Secondary Outcome
Pain Wong-Baker pain rating scale (WBS)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The two parallel groups will receive the maxillary anaesthesia injection by the same operator. In the pre-operative period, MCDAS(f), a self-report measure of anxiety will be recorded for all the children. Measuring preoperative dental anxiety (expressed by heart rate) using pulse oximeter For Group A (sweet orange oil group): Aromatherapy with inhalers will be carried out, The children will be asked to inhale the aroma from the inhaler For Group B (Control Group): No aromatherapy inhalation . Administration of topical anesthesia . Administration of local anesthesia . After LA administration, Wong-Baker pain rating scale (WBS) will be recorded as a self report measure of pain for all the children. After LA administration, anxiety will be recorded again using MCDAS(f) for all the children. Measuring postoperative dental anxiety (expressed by heart rate ) using pulse oximeter.
| Arm | Type | Receives |
|---|---|---|
| Group A (sweet orange oil group) | Experimental | Other: sweet orange oil inhalationAromatherapy with inhalers will be carried out in an open clinical setting. Three drops of sweet orange oil will be dispensed into a cotton wick of the inhaler, The children will be asked to inhale the aroma from the inhalers for 2 minutes followed by an induction period of 15 minutes. |
| For Group B (Control Group) | No intervention | –No aromatherapy inhalation |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Children classified with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.
Key exclusion criteria (7 listed)
- Children with any neurological or psychological disorders.
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 |
|---|---|---|
| sweet orange oil inhalationsweet orange oil with inhalers will be carried out in an open clinical setting. Three drops of sweet orange oil will be dispensed into a cotton wick of the inhaler, The children will be asked to inhale the aroma from the inhalers for 2 minutes followed by an induction period of 15 minutes | Other | Group A (sweet orange oil group) |
Primary outcome
Anxiety
Time frame: Through study completion , within 10 months
Pulse rate
Anxiety
Time frame: Through study completion , within 10 months
Modified child dental anxiety scale
1 secondary outcome
Dental pain
Time frame: Through study completion , within 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Background: PubMed 34849354Nirmala K, Kamatham R. Effect of Aromatherapy on Dental Anxiety and Pain in Children Undergoing Local Anesthetic Administrations: A Randomized Clinical Trial. J Caring Sci. 2021 Aug 23;10(3):111-120. doi: 10.34172/jcs.2021.026. eCollection 2021 Aug.
Related trials for Aromatherapy
Enrolling by invitation
The Effect of Peppermint Oil Aromatherapy on Pain, Functional Capacity and Cost in Fibromyalgia Patients
Fibromyalgia, Aromatherapy
Not yet recruiting
"The Effect of Lavender Aromatherapy on Dental Anxiety"
Aromatherapy (Geranium Essential Oil)
Recruiting
Aromatherapy Inhaler Use for HSCT Distress
Cancer Distress, Cancer Coping
Not yet recruitingPhase 3
Aromatherapy Combined With Standard Antiemetic Therapy vs Standard Therapy Alone for Prevention of CINV in Breast Cancer Patients Receiving Highly Emetogenic Chemotherapy
Breast Cancer, Aromatherapy
Recruiting
Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement:
Aromatherapy
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.
Questions about this trial
What is this clinical trial studying?
A study testing sweet orange oil inhalation in people with Aromatherapy, run by Cairo University.
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 7 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 2 Oct 2023. 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?
Contact shaimaa abdelazim, masters (+2001120155777, shimaa.abdelazeem@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Through study completion , within 10 months). 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 NCT06063512, 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 2 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.