Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000797673
Ethics application status
Approved
Date submitted
9/04/2023
Date registered
26/07/2023
Date last updated
26/07/2023
Date data sharing statement initially provided
26/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of aromatherapy and music on anxiety, perioperative pain and physiological parameters in patients undergoing extraction of impacted third molars
Scientific title
Evaluation of the effectiveness of aromatherapy and music on anxiety, perioperative pain and physiological parameters in adults undergoing extraction of impacted third molars
Secondary ID [1] 309414 0
AGC-AFM-2023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 329664 0
Anxiety 329665 0
Impacted third molar 329666 0
Condition category
Condition code
Surgery 326571 326571 0 0
Other surgery
Anaesthesiology 326572 326572 0 0
Pain management
Mental Health 326573 326573 0 0
Anxiety
Oral and Gastrointestinal 327033 327033 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized clinical trial with three groups: experimental 1 (91 patients) who will undergo surgical extraction of the third molar receiving musical stimulation during the surgical procedure. Experimental group 2 (91 patients) to which aromatherapy will be applied during the surgical procedure. And control group (91 patients) that will be the patients who will undergo the extraction of the third molar without receiving musical stimulation or aromatherapy during the surgical procedure.

Experimental group 1 (MUSIC group):
Patients who will be included in the music therapy intervention group will receive an electronic acoustic reproduction device iPod, with wireless headphones (Trust Urban). “Introduction and Allegro for harp, flute, clarinet, and string quartet” by Ravel and “Aria” by J.S. Bach are selected as the playlist to be played during the procedure, as they are considered relaxing instrumental music.
This device will allow the patient to listen to music when unaccompanied, both presurgery (in the preoperative holding area) and during surgery (in the operating room), with a duration of 20 minutes each time.

In the preoperative holding area, when the patient is unaccompanied, the device will be given 20 minutes before the extraction (volume of 60-70 decibels to avoid risk of acoustic damage). The basic vital signs: systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SAT O2) and heart rate (HR), will be taken and the STAI-Y1 and STAI-Y2 questionnaire will be carried out. After 20 minutes alone and listening to music, the patient goes to the operating room where the surgery is performed while the patient uses the music player during surgery.
During surgery, new basic vital signs will be taken: systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SAT O2) and heart rate (HR) using the same tower with which they were taken in the preoperative holding area. These constants will be taken at different times during the surgical act: during the infiltration of local anesthetic (articaine with epinephrine 40/0.005mg/ml (trade name Ultracain ®)); during the osteotomy and dental section carried out with a handpiece at 40,000 revolutions with a 23 milling cutter; and after the closure of the flap and placement of local compressive gauze.
20 minutes after the surgery, the STAI-Y1, STAI-Y2 questionnaire will be passed again and new basic vital signs will be taken. And finally, a visual analog scale (VAS) will be used to indicate the perioperative pain experienced by the patient.

Intervention group 2 (AROMATHERAPY GROUP):
The aromatherapy will be applied using a dispenser that will contain 100% pure lavender oil essence (4 drops in 150 ml of distilled water).
The procedure will be carried out in the same way as in the intervention group with music therapy (the patient will be alone for 20 minutes in the preoperative holding area receiving the aromatherapy and then they will go to the operating room, using the device during surgery).

As a strategy to monitor adherence or fidelity to the intervention, the "directly observed therapy" method will be used. To do this, a health professional will fill out a check-list in which they will verify that each patient is receiving the intervention indicated according to the protocol.
Intervention code [1] 325848 0
Treatment: Devices
Intervention code [2] 326200 0
Treatment: Other
Comparator / control treatment
The control group will be made up of patients who will undergo third molar extraction without musical stimulation or aromatherapy application at any time (neither during the preoperative period in the preoperative holding area, nor during the surgical procedure).
Control group
Active

Outcomes
Primary outcome [1] 334419 0
Level of perioperative anxiety assessed by the State and Trait Anxiety Inventory (STAI)
Timepoint [1] 334419 0
20 minutes Pre and 20 minutes Post-operative
Primary outcome [2] 334420 0
Level of perioperative pain assessed by 100 mm VAS scale
Timepoint [2] 334420 0
Patient will fill in the VAS scale 20 minutes after the intervention, indicating the pain felt during the surgery
Secondary outcome [1] 420573 0
Blood pressure (sphyngomanometer).
Timepoint [1] 420573 0
We collect these parameters: the first time we evaluate the patient (one week before the surgery), 20 minutes before surgery, during the infiltration of local anesthesia, during osteotomy, at the end of the extraction of the third molar, and 20 minutes after surgery.
Secondary outcome [2] 420576 0
Oxygen saturation (saturometer).
Timepoint [2] 420576 0
We collect these parameter: the first time we evaluate the patient (one week before the surgery), 20 minutes before surgery, during the infiltration of local anesthesia, during ostectomy, at the end of the extraction of the third molar, and 20 minutes after surgery.
Secondary outcome [3] 422404 0
Heart rate (pulse oximeter)
Timepoint [3] 422404 0
We collect these parameter: the first time we evaluate the patient (one week before the surgery), 20 minutes before surgery, during the infiltration of local anesthesia, during ostectomy, at the end of the extraction of the third molar, and 20 minutes after surgery.

Eligibility
Key inclusion criteria
1. Adult patients between 18-50 years of age (age at which the eruption or the pathologies derived from the lack of eruption occures)
2. Both men and women will be selected
3. Single procedure per surgical act, that is, only one extraction per patient and episode.
4. Procedure performed under exclusive local anesthesia.
5. Patients who agree to participate in the study and sign the Informed Consent form.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients under 18 years of age or over 50 years of age.
2. Multiple procedure, that is, dental polyextraction in the same surgical act.
3. Patients with deafness or with hearing pathology.
4. Patients with anosmia or significant loss of smell.
5. Patients who suffer from epilepsy or have had an epileptic seizure in the last 6 months.
6. Anticoagulated patients or with bleeding disorders.
7. Patients undergoing cancer treatment or immunosuppressed.
8. Patients being treated with bisphosphonates.
9. Patients with systemic pathology that may interfere with the result.
10. Patients who have received locoregional radiotherapy.
11. Previous surgery in the lower retromolar trigone area.
12. Disabled patients, non-collaborators.
13. Patients unable to understand and fill in the visual analog scale and the anxiety questionnaire.
14. Patients operated under general anesthesia and / or sedation.
15. Presence of active suppurative infection at the time of surgery.
16. Pregnant patients or possibility of pregnancy (verified by pregnancy test).
17. Patient who does not want or authorize to participate in the study or does not have a correct command or understanding of the Spanish language.
18. Patients with severe cardiac impulse conduction dysfunctions.
19. Patients with decompensated heart failure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised controlled trial.

Allocation concealment will be performed using central randomization by computer.

To do this, during the first clinical interview, a number is assigned to each patient who consents to enter the study.

Afterwards, 297 sets of numbers will be created, each of which will contain numbers ranging from 1 to 3 in random order. Each number corresponds to a group: group 1 (experimental group 1), group 2 (experimental group 2) and group 3 (control group).

After signing the consent, a code will be randomly chosen for each patient.

Neither the patient nor the people assessing the outcomes nor the people analyzing the results/data know to which group each patient belongs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The online Randomizer 18 (Research Randomizer, 1997) will be used to randomly generate 297 sets of numbers, each of which will contain two numbers ranging from 1 to 3 in random order. A total of 273 unique codes will be generated based on the 91 sets of {1, 2 and 3} (eg Set1Group1, Set1Group2, Set1Group3) and placed in a box. After signing the consent, a code will be randomly chosen for each patient, to ensure that the 273 patients will be equally distributed into three groups according to the group number of each code: group 1 (experimental group 1), group 2 (experimental group 2) and group 3 (control group).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A database will be prepared with all the variables described and their statistical treatment will be carried out with the SPSS 22.0 program.
Univariate or descriptive analysis will be performed. For the qualitative variables, frequencies will be calculated with their corresponding percentages and for the quantitative variables measures of central tendency and measures of dispersion (mean, minimum, maximum and standard deviation) will be carried out.
In the bivariate analysis, for the comparison of qualitative variables, the Chi-square test (X2) will be applied, considering a value of p<0.005 significant. For the comparison of means of quantitative variables, prior normality test (Kolmogorov-Smirnov Test), parametric or non-parametric tests will be applied, as appropriate, for variables with normal distribution, the T-Student Test will be used for independent variables, T-Student test for paired variables and ANOVA of one factor with its corresponding "post hot" test, for variables that do not follow a non-normal distribution, Mann-Whitney U test to compare independent variables, Wilcoxon test for paired variables , Kruskal-Wallis for more than two independent variables, and the Friedman test for more than two paired variables.
The multivariate analysis will be carried out using binary logistic regression, using musical intervention (yes/no) or virtual reality (yes/no) as the dependent variable and all those considered to have influenced the model as independent variables. The Hosmer-Lemeshow goodness-of-fit test and a statistical significance of p<0.05 will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
273
Accrual to date
Final
Recruitment outside Australia
Country [1] 25389 0
Spain
State/province [1] 25389 0
Almería

Funding & Sponsors
Funding source category [1] 313608 0
Hospital
Name [1] 313608 0
Hospital Universitario Torrecárdenas
Country [1] 313608 0
Spain
Primary sponsor type
Individual
Name
Ana Rocío García Carricondo
Address
Servicio de Cirugía Oral y Maxilofacial
Hospital Universitario Torrecárdenas
C/ Hermandad de Donantes de Sangre, s/n
04009, Almería
Spain
Country
Spain
Secondary sponsor category [1] 315401 0
Individual
Name [1] 315401 0
Antonio Francisco Ferrández Martínez
Address [1] 315401 0
Servicio de Cirugía Oral y Maxilofacial
Hospital Universitario Torrecárdenas
C/ Hermandad de Donantes de Sangre, s/n
04009, Almería
Spain
Country [1] 315401 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312783 0
COMITE DE ETICA DE LA INVESTIGACION DE ALMERIA
Ethics committee address [1] 312783 0
Calle Hermandad de Donantes de Sangre, s/n, 04009 Almería
Ethics committee country [1] 312783 0
Spain
Date submitted for ethics approval [1] 312783 0
10/02/2023
Approval date [1] 312783 0
30/03/2023
Ethics approval number [1] 312783 0
AGC-AFM-2023 (47/2023)

Summary
Brief summary
Background: Surgical extraction under local anesthesia of impacted third molars is a procedure that generates stress, fear and anxiety in the patient, which is why there is interest in finding and applying non-invasive therapies, with the aim of mitigating and improving these undesirable states. Music therapy and aromatherapy are disciplines on the rise in the field of medicine, especially in areas aimed at controlling pain and anxiety.

Objective: The objective of the study is to evaluate the role of aromatherapy and music in the reduction of anxiety and perioperative pain in patients who undergo surgical extraction of impacted third molars under local anesthesia.

Methods: a controlled clinical trial (RCT) of parallel groups has been proposed, with three groups: experimental 1 (91 patients) who will undergo the surgical extraction of the third molar receiving musical stimulation during the surgical procedure. Experimental group 2 (91 patients) to which aromatherapy will be applied during the surgical procedure. And a control group (91 patients) that will be the patients who will undergo the extraction of the third molar without receiving musical stimulation or aromatherapy during the surgical procedure. The variables to be studied will be: the evaluation of anxiety and pain in all the subjects that make up the three arms of the trial, being evaluated by means of the State and Trait Anxiety Questionnaire (STAI) and the numerical visual analogue scale (VAS). And epidemiological variables such as age, sex, dental laterality, degree of inclusion, variation in basic vital signs (FC, Sat O2, TA).

Expected Results: Patients undergoing aromatherapy and music therapy are expected to have lower levels of anxiety and pain compared to the control group. Physiological parameters will also improve in the intervention group.

Practical implications: The implementation of these interventions (non-invasive, non-pharmacological and inexpensive) in the field of oral and maxillofacial surgery could improve procedures performed under local anesthesia, improving the clinical experience of patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125902 0
Dr Ana Rocio Garcia Carricondo
Address 125902 0
Servicio de Cirugía Oral y Maxilofacial. Hospital Universitario Torrecárdenas. Calle Hermandad de Donantes de Sangre s/n, 04009, Almería, Almería (Spain)
Country 125902 0
Spain
Phone 125902 0
+34625088560
Fax 125902 0
Email 125902 0
argcarricondo@hotmail.es
Contact person for public queries
Name 125903 0
Mr Antonio Francisco Ferrandez Martinez
Address 125903 0
Servicio de Cirugía Oral y Maxilofacial. Hospital Universitario Torrecárdenas. Calle Hermandad de Donantes de Sangre s/n, 04009, Almería, Almería (Spain)
Country 125903 0
Spain
Phone 125903 0
+34670020864
Fax 125903 0
Email 125903 0
antoniofm95@hotmail.com
Contact person for scientific queries
Name 125904 0
Mr Antonio Francisco Ferrandez Martinez
Address 125904 0
Servicio de Cirugía Oral y Maxilofacial. Hospital Universitario Torrecárdenas. Calle Hermandad de Donantes de Sangre s/n, 04009, Almería, Almería (Spain)
Country 125904 0
Spain
Phone 125904 0
+34670020864
Fax 125904 0
Email 125904 0
antoniofm95@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data is confidential and will remain protected in the hospital


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18828Ethical approval  antoniofm95@hotmail.com 385711-(Uploaded-09-04-2023-01-13-10)-Study-related document.pdf
18829Study protocol  antoniofm95@hotmail.com 385711-(Uploaded-09-04-2023-01-19-49)-Study-related document.pdf
18830Informed consent form  antoniofm95@hotmail.com 385711-(Uploaded-09-04-2023-01-21-48)-Study-related document.pdf



Results publications and other study-related documents

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