Anxiety and FearNCT06388265
Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars
A study testing Trifold information in people with Anxiety and Fear, run by University of Barcelona at 1 site in Spain.
Trial summary
Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Fear
- What is being tested?
- Trifold information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2022to 31 Jul 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals 18 years old or older, from both genders that wished to voluntarily participate in the study and that required the extraction of third molars.
Who cannot join
- Systemic diseases (ASA III or IV) that contraindicate the performance of the surgical procedure
- Pregnant women
- Individuals that did not understand and/or could not respond the given questionnaire.
- Patients that required the extraction of a different tooth than a third molar or that required the extraction of more than two third molars in the same surgical time.
- Patients who had undergone extraction of a third molar in the twelve months prior to the current visit.
- Patients taking antidepressant medication or anxiolytic medication
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Odontològic Universitat de Barcelona
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona.
- Conditions
- Anxiety and Fear
- Being tested
- Trifold information
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifold informationOther
Additional detailed and written information about the procedure will be given to the participants
| Study group | Role | What they receive |
|---|---|---|
| Verbal and Written detailed information | Experimental | The experimental group will receive verbal information about the procedure (exodontia of third molars) and additionally a trifold with detailed information about the surgical procedure. Receives: Other: Trifold information |
| Control | No intervention | The control group will only receive verbal information about the surgical procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in STAI-S
The Anxiety State scale (S-Anxiety) is an inventory that has been validated and assesses the current state of anxiety of the participant measured through an auto evaluation, asking how the evaluated individual feels "in this moment", using items that measure subjective feelings of apprehension, tension, nervousness, worry and activation/excitement of the autonomic nervous system.
The total scores can go from 20 to 80 points A cut point value of 39 to 40 points has been suggested to detect clinically significant symptoms in the Anxiety State scale.
STAI-S will be assessed in 4 stages:
- At the initial consultation (baseline)
- Immediately before the procedure and administration of the local anaesthetic solution
- Immediately after the procedure is completed
- 1 week after the procedure (exodontia)
Measured: Through study completion, an average of 5 weeks
Changes in MDAS
The modified dental anxiety scale (MDAS) is an auto evaluation questionnaire about dental anxiety that contains 5 items, each one with 5 possible answers that reflects in order an increase of anxiety (no anxiety to extremely anxious).
The total score can go from 5 points to a maximum of 25 points. The lower limit to define an individual with extreme anxiety is 19 points and to define the presence of anxiety the score must be higher than 10 points.
MDAS will be assessed in 2 stages:
- At the initial consultation (baseline)
- Immediately before the procedure and administration of the local anaesthetic solution
Measured: up to 3 weeks
Secondary outcomes (4)
Changes in blood pressure
Changes in Blood pressure (Systolic and dyastolic) measured in mmHg
Blood pressure will be assessed in 5 stages:
- At the initial consultation (baseline)
- Immediately before the procedure and administration of the local anaesthetic solution
- Immediately after administration of the local anaesthetic solution
- Immediately after the procedure is completed
Measured: Through study completion, an average of 5 weeks
Changes in Heart rate
Changes in heart rate measured in beats per minute
Heart rate will be assessed in 5 stages:
- At the initial consultation (baseline)
- Immediately before the procedure and administration of the local anaesthetic solution
- Immediately after administration of the local anaesthetic solution
- Immediately after the procedure is completed
Measured: Through study completion, an average of 5 weeks
Changes in Oxygen saturation
Changes in oxygen saturation measured in percentage (%)
Oxygen saturation will be assessed in 5 stages:
- At the initial consultation (baseline)
- Immediately before the procedure and administration of the local anaesthetic solution
- Immediately after administration of the local anaesthetic solution
- Immediately after the procedure is completed
Measured: Through study completion, an average of 5 weeks
Patient Satisfaction of procedure
A questionnaire will be provided to the participants that consists of 6 questions, 2 questions to know the degree of discomfort at the last visit (suture removal control post exodontia) with 4 possible answers: none, little, moderate, a lot; and 4 questions to determine the degree of satisfaction with all the dental treatment carried out with affirmative or negative answers
Measured: 1 week after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start9 Jan 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies 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
- Care provider
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayra Schemel Suarez, University of Barcelona
- Investigators
- José López-López, PhD, Study director, University of BarcelonaMayra Schemel Suarez, DDS, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388265
- Sponsor's protocol ID
- 18/2018, Acta 26-6-2018
- Status last verified
- Nov 2025
- First submitted
- 20 Apr 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars
- ClinicalTrials.gov ID
- NCT06388265
- Acronym / sponsor ID
- 18/2018, Acta 26-6-2018
- Conditions
- Anxiety and Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 9 Jan 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 29 Apr 2024 (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.
Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal and Written detailed information | Experimental | Other: Trifold informationThe experimental group will receive verbal information about the procedure (exodontia of third molars) and additionally a trifold with detailed information about the surgical procedure. |
| Control | No intervention | –The control group will only receive verbal information about the surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals 18 years old or older, from both genders that wished to voluntarily participate in the study and that required the extraction of third molars.
Key exclusion criteria (6 listed)
- Systemic diseases (ASA III or IV) that contraindicate the performance of the surgical procedure
- Pregnant women
- Individuals that did not understand and/or could not respond the given questionnaire.
- Patients that required the extraction of a different tooth than a third molar or that required the extraction of more than two third molars in the same surgical time.
- Patients who had undergone extraction of a third molar in the twelve months prior to the current visit.
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 |
|---|---|---|
| Trifold informationAdditional detailed and written information about the procedure will be given to the participants | Other | Verbal and Written detailed information |
Primary outcome
Changes in STAI-S
Time frame: Through study completion, an average of 5 weeks
The Anxiety State scale (S-Anxiety) is an inventory that has been validated and assesses the current state of anxiety of the participant measured through an auto evaluation, asking how the evaluated individual feels "in this moment", using items that measure subjective feelings of apprehension, tension, nervousness, worry and activation/excitement of the autonomic nervous system. The total scores can go from 20 to 80 points A cut point value of 39 to 40 points has been suggested to detect clinically significant symptoms in the Anxiety State scale. STAI-S will be assessed in 4 stages: 1. At the initial consultation (baseline) 2. Immediately before the procedure and administration of the local anaesthetic solution 3. Immediately after the procedure is completed 4. 1 week after the procedure (exodontia)
Changes in MDAS
Time frame: up to 3 weeks
The modified dental anxiety scale (MDAS) is an auto evaluation questionnaire about dental anxiety that contains 5 items, each one with 5 possible answers that reflects in order an increase of anxiety (no anxiety to extremely anxious). The total score can go from 5 points to a maximum of 25 points. The lower limit to define an individual with extreme anxiety is 19 points and to define the presence of anxiety the score must be higher than 10 points. MDAS will be assessed in 2 stages: 1. At the initial consultation (baseline) 2. Immediately before the procedure and administration of the local anaesthetic solution
4 secondary outcomes
Changes in blood pressure
Time frame: Through study completion, an average of 5 weeks
Changes in Heart rate
Time frame: Through study completion, an average of 5 weeks
Changes in Oxygen saturation
Time frame: Through study completion, an average of 5 weeks
Patient Satisfaction of procedure
Time frame: 1 week after the procedure
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 19 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Anxiety and Fear
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
Fear of Childbirth, Mandala Coloring
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 2
Psilocybin FCR Early-Stage Breast Cancer
Early-stage Breast Cancer, Fear of Cancer Recurrence
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.
José López-López, PhD study director
University of Barcelona
Mayra Schemel Suarez, DDS principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trifold information in people with Anxiety and Fear, run by University of Barcelona at 1 site in Spain.
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 6 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 19 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 Spain. 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?
Changes in STAI-S (time frame: Through study completion, an average of 5 weeks). 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?
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 19 Nov 2025.