Tooth ExtractionNCT03545022
Acupuncture on Anxiety and Inflammatory Events Following Surgery of Mandibular Third Molars
A study testing Acupuncture in people with Tooth Extraction and Molar, Third, run by Federal University of the Valleys of Jequitinhonha and Mucuri.
Trial summary
The aim of this study was to compare the effect of acupuncture and placebo acupuncture for the control of pain, edema, and trismus following the extraction of third molars and control of preoperative anxiety. Read more about this study
- Who is it for?
- Ages 17 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction, Molar, Third, Pain, Postoperative
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Mar 2017
- 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 17 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with indication for bilateral extraction of asymptomatic mandibular third molars in the position class IIB, according to the classification of Pell \& Gregory (1933).
Who cannot join
- Previous use of any type of medication in the 15 days prior to the study;
- Hypersensitivity to drugs, substances or any materials used in this experiment;
- Pregnancy or lactation;
- Previous case of pericoronitis;
- People who have previously undergone any kind of acupuncture treatment.
About this study
The aim of this study was to compare the effect of acupuncture and placebo acupuncture for the control of pain, edema, and trismus following the extraction of third molars and control of preoperative anxiety. Patients who met the study criteria were randomized to the type of acupuncture (active acupuncture or placebo acupuncture) and to the side of the first surgery (right or left).
Read the detailed description
Studies using acupuncture have shown promising results in the control of pain, edema, trismus and anxiety control. The use of this technique is interesting considering the negative effects of excessive use of medicines and the side effects of medications which are the most common treatment used for the control of these complications. However, there are no reports in the literature that evaluated the effects of acupuncture on the control of these variables following mandibular third molar extraction, using the placebo-needle design and blinding the patients, operators, and evaluators. Therefore, the aim of this split-mouth randomized triple-blind clinical trial was to compare the efficacy of acupuncture and placebo acupuncture for the control of pain, edema, trismus and preoperative anxiety in the extraction of third molars.
- Conditions
- Tooth Extraction, Molar, Third, Pain, Postoperative, Trismus, Edema, Anxiety
- Being tested
- Acupuncture
- Keywords
- third molar, acupuncture, pain, edema, trismus, anxiety
- Medical subject headings
- Pain, Postoperative, Trismus, Edema, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
The application of acupuncture was performed in four sessions, 30 minutes prior to surgery, 24, 48 and 72 hours following the surgery, before variables measurements. The points were manually stimulated and the needles were inserted up to 4mm. There were 11 points, applied bilaterally, two of them, point VG20 and Yintang, for anxiety control, only at the preoperative time and not bilateral. The points to reduce pain, edema, and trismus were IG4 (Hegu), F3 (Taichong) and E44 (Neiting), TA21 (Ermen), ID19 (Ting-Kong), E6 (Jiagle) and E7 (Towei) , point B60 (Kunlum) and VB34 (Yanglingquan). All patients received the same treatment in all sessions.
After the needle devices were inserted, the needles were re-stimulated manually once after 10 minutes and removed after more 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active acupuncture | Active comparator | For both types of treatment, 0.25x30mm stainless steel needles were used (Dux, Brazil).The protocols were differentiated by needle size, in which the placebo needle is not inserted into the patient's skin and has an identical appearance to the active needle.The needle measuring 0.25x30mm was used as an active needle. The needles were inserted partially into an opaque guide tube filled with condensation silicone. This process was used to simulate the needle insertion for the patient and the acupuncturist and for the needle support. The active needle as well as the placebo needle were attached to the skin with an adhesive pedestal to hold the needle in place, even without inserting it into the skin. Receives: Procedure: Acupuncture |
| Placebo acupuncture | Placebo comparator | For both types of treatment, 0.25x30mm stainless steel needles were used (Dux, Brazil).The protocols were differentiated by needle size, in which the placebo needle is not inserted into the patient's skin and has an identical appearance to the active needle. In the placebo needle, the needles were cut in 5mm, to measure 0.25x25mm. The needles were inserted partially into an opaque guide tube filled with condensation silicone. This process was used to simulate the needle insertion for the patient and the acupuncturist and for the needle support. The active needle, as well as the placebo needle, were attached to the skin with an adhesive pedestal to hold the needle in place, even without inserting it into the skin. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and intensity of postoperative pain at 24 hours following the surgery
For the evaluation of the presence and intensity of postoperative pain, a coded record (Protocol 1 or 2) was used, identifying the patient, the operated side and the chronology of the intervention (first or second surgery). Each record contained three visual analog scales (VAS) with a 10 cm line, without demarcations, with the number 0 (no pain) on the left edge and the number 10 on the right edge (extreme pain). The volunteers were instructed to mark, with a vertical trace, the point of the scale that best defined their degree of painful sensitivity after surgical procedures, which was measured with a ruler afterward.
Measured: The marking was performed at 24 hours postoperatively.
Presence and intensity of postoperative pain at 48 hours following the surgery.
For the evaluation of the presence and intensity of postoperative pain, a coded record (Protocol 1 or 2) was used, identifying the patient, the operated side and the chronology of the intervention (first or second surgery). Each record contained three visual analog scales (VAS) with a 10 cm line, without demarcations, with the number 0 (no pain) on the left edge and the number 10 on the right edge (extreme pain). The volunteers were instructed to mark, with a vertical trace, the point of the scale that best defined their degree of painful sensitivity after surgical procedures, which was measured with a ruler afterward.
Measured: The marking was performed at 48 hours postoperatively.
Presence and intensity of postoperative pain at 72 hours following the surgery.
For the evaluation of the presence and intensity of postoperative pain, a coded record (Protocol 1 or 2) was used, identifying the patient, the operated side and the chronology of the intervention (first or second surgery). Each record contained three visual analog scales (VAS) with a 10 cm line, without demarcations, with the number 0 (no pain) on the left edge and the number 10 on the right edge (extreme pain). The volunteers were instructed to mark, with a vertical trace, the point of the scale that best defined their degree of painful sensitivity after surgical procedures, which was measured with a ruler afterward.
Measured: The marking was performed at 72 hours postoperatively.
Change from baseline facial swelling (edema) at 24 hours following the surgery.
Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).
Measured: The measurements were obtained preoperatively (baseline) and at 24 hours following the surgery.
Change from baseline facial swelling (edema) at 48 hours following the surgery.
Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).
Measured: The measurements were obtained preoperatively (baseline) and at 48 hours following the surgery.
Change from baseline facial swelling (edema) at 72 hours following the surgery.
Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).
Measured: The measurements were obtained preoperatively (baseline) and at 72 hours following the surgery.
Change from baseline facial swelling (edema) at 7 days following the surgery.
Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).
Measured: The measurements were obtained preoperatively (baseline) and at 7 days following the surgery.
Change from baseline mouth opening at 24 hours following the surgery.
The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.
Measured: The measurement was determined in the preoperative period (baseline) and at the period of 24 hours following the surgery.
Change from baseline mouth opening at 48 hours following the surgery.
The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.
Measured: The measurement was determined in the preoperative period (baseline) and at the period of 48 hours following the surgery.
Change from baseline mouth opening at 72 hours following the surgery.
The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.
Measured: The measurement was determined in the preoperative period (baseline) and at the period of 72 hours following the surgery.
Change from baseline mouth opening at 7 days following the surgery.
The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.
Measured: The measurement was determined in the preoperative period (baseline) and at the period of 7 days following the surgery.
Change of anxiety state scores using STAI questionnaire at the moment before the preoperative acupuncture and after the acupuncture.
Anxiety was evaluated with the Spielberger State-Trait Anxiety Inventory (STAI) questionnaire, translated and validated to Portuguese by Biaggio et al. (1977). The STAI is a validated questionnaire consisting of two parts, each with 20 questions. One part, STAI-S, evaluates the state of anxiety which is defined as anxiety in response to a situation. The other part, STAI-T, evaluates the anxiety trait, defined by the level of anxiety normally felt by the person. The two parts can be scored from 20 to 80, with the highest values indicating the highest rates of anxiety. Values ≥40 indicate a high level of anxiety and ≥50 as very high.
Measured: The STAI-S questionnaires were applied before the preoperative acupuncture and after acupuncture.
Change of anxiety state scores using a Visual Analogue Scale (VAS) questionnaire at the moment before the preoperative acupuncture and after the acupuncture.
A visual analog scale (VAS) consisted of a 10cm line, without divisions was used. The patients were instructed to mark the level of anxiety at that moment, with the "0" without anxiety and "10", with a high level of anxiety, that was measured with a ruler later.
Measured: The VAS were applied before the preoperative acupuncture and after acupuncture.
Secondary outcomes (2)
Duration of surgery
The duration of surgery was recorded with a stopwatch in seconds.
Measured: From the time of the initial incision to the time of the final suture.
Number of painkillers tablets
The number of paracetamol tablets taken after the surgery was registered by the patient.
Measured: By the seventh postoperative day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study startAug 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Catharina V Armond, Principal investigator, Federal University of Jequitinhonha and Mucuri Valleys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545022
- Sponsor's protocol ID
- 1.688.806
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- 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 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture on Anxiety and Inflammatory Events Following Surgery of Mandibular Third Molars
- ClinicalTrials.gov ID
- NCT03545022
- Acronym / sponsor ID
- 1.688.806
- Conditions
- Tooth Extraction, Molar, Third, Pain, Postoperative, Trismus, Edema, Anxiety
- Keywords
- third molar, acupuncture, pain, edema, trismus, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 4 Jun 2018 (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 aim of this study was to compare the effect of acupuncture and placebo acupuncture for the control of pain, edema, and trismus following the extraction of third molars and control of preoperative anxiety. Patients who met the study criteria were randomized to the type of acupuncture (active acupuncture or placebo acupuncture) and to the side of the first surgery (right or left).
Detailed description
Studies using acupuncture have shown promising results in the control of pain, edema, trismus and anxiety control. The use of this technique is interesting considering the negative effects of excessive use of medicines and the side effects of medications which are the most common treatment used for the control of these complications. However, there are no reports in the literature that evaluated the effects of acupuncture on the control of these variables following mandibular third molar extraction, using the placebo-needle design and blinding the patients, operators, and evaluators. Therefore, the aim of this split-mouth randomized triple-blind clinical trial was to compare the efficacy of acupuncture and placebo acupuncture for the control of pain, edema, trismus and preoperative anxiety in the extraction of third molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active acupuncture | Active comparator | Procedure: AcupunctureFor both types of treatment, 0.25x30mm stainless steel needles were used (Dux, Brazil).The protocols were differentiated by needle size, in which the placebo needle is not inserted into the patient's skin and has an identical appearance to the active needle.The needle measuring 0.25x30mm was used as an active needle. The needles were inserted partially into an opaque guide tube filled with condensation silicone. This process was used to simulate the needle insertion for the patient and the acupuncturist and for the needle support. The active needle as well as the placebo needle were attached to the skin with an adhesive pedestal to hold the needle in place, even without inserting it into the skin. |
| Placebo acupuncture | Placebo comparator | Procedure: AcupunctureFor both types of treatment, 0.25x30mm stainless steel needles were used (Dux, Brazil).The protocols were differentiated by needle size, in which the placebo needle is not inserted into the patient's skin and has an identical appearance to the active needle. In the placebo needle, the needles were cut in 5mm, to measure 0.25x25mm. The needles were inserted partially into an opaque guide tube filled with condensation silicone. This process was used to simulate the needle insertion for the patient and the acupuncturist and for the needle support. The active needle, as well as the placebo needle, were attached to the skin with an adhesive pedestal to hold the needle in place, even without inserting it into the skin. |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with indication for bilateral extraction of asymptomatic mandibular third molars in the position class IIB, according to the classification of Pell \& Gregory (1933).
Key exclusion criteria (5 listed)
- Previous use of any type of medication in the 15 days prior to the study;
- Hypersensitivity to drugs, substances or any materials used in this experiment;
- Pregnancy or lactation;
- Previous case of pericoronitis;
- People who have previously undergone any kind of acupuncture treatment.
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 |
|---|---|---|
| AcupunctureThe application of acupuncture was performed in four sessions, 30 minutes prior to surgery, 24, 48 and 72 hours following the surgery, before variables measurements. The points were manually stimulated and the needles were inserted up to 4mm. There were 11 points, applied bilaterally, two of them, point VG20 and Yintang, for anxiety control, only at the preoperative time and not bilateral. The points to reduce pain, edema, and trismus were IG4 (Hegu), F3 (Taichong) and E44 (Neiting), TA21 (Ermen), ID19 (Ting-Kong), E6 (Jiagle) and E7 (Towei) , point B60 (Kunlum) and VB34 (Yanglingquan). All patients received the same treatment in all sessions. After the needle devices were inserted, the needles were re-stimulated manually once after 10 minutes and removed after more 10 minutes. | Procedure or surgery | Active acupuncture, Placebo acupuncture |
Primary outcome
Presence and intensity of postoperative pain at 24 hours following the surgery
Time frame: The marking was performed at 24 hours postoperatively.
For the evaluation of the presence and intensity of postoperative pain, a coded record (Protocol 1 or 2) was used, identifying the patient, the operated side and the chronology of the intervention (first or second surgery). Each record contained three visual analog scales (VAS) with a 10 cm line, without demarcations, with the number 0 (no pain) on the left edge and the number 10 on the right edge (extreme pain). The volunteers were instructed to mark, with a vertical trace, the point of the scale that best defined their degree of painful sensitivity after surgical procedures, which was measured with a ruler afterward.
Presence and intensity of postoperative pain at 48 hours following the surgery.
Time frame: The marking was performed at 48 hours postoperatively.
For the evaluation of the presence and intensity of postoperative pain, a coded record (Protocol 1 or 2) was used, identifying the patient, the operated side and the chronology of the intervention (first or second surgery). Each record contained three visual analog scales (VAS) with a 10 cm line, without demarcations, with the number 0 (no pain) on the left edge and the number 10 on the right edge (extreme pain). The volunteers were instructed to mark, with a vertical trace, the point of the scale that best defined their degree of painful sensitivity after surgical procedures, which was measured with a ruler afterward.
Presence and intensity of postoperative pain at 72 hours following the surgery.
Time frame: The marking was performed at 72 hours postoperatively.
For the evaluation of the presence and intensity of postoperative pain, a coded record (Protocol 1 or 2) was used, identifying the patient, the operated side and the chronology of the intervention (first or second surgery). Each record contained three visual analog scales (VAS) with a 10 cm line, without demarcations, with the number 0 (no pain) on the left edge and the number 10 on the right edge (extreme pain). The volunteers were instructed to mark, with a vertical trace, the point of the scale that best defined their degree of painful sensitivity after surgical procedures, which was measured with a ruler afterward.
Change from baseline facial swelling (edema) at 24 hours following the surgery.
Time frame: The measurements were obtained preoperatively (baseline) and at 24 hours following the surgery.
Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).
Change from baseline facial swelling (edema) at 48 hours following the surgery.
Time frame: The measurements were obtained preoperatively (baseline) and at 48 hours following the surgery.
Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).
Change from baseline facial swelling (edema) at 72 hours following the surgery.
Time frame: The measurements were obtained preoperatively (baseline) and at 72 hours following the surgery.
Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).
Change from baseline facial swelling (edema) at 7 days following the surgery.
Time frame: The measurements were obtained preoperatively (baseline) and at 7 days following the surgery.
Facial swelling (edema) was determined by measuring with tape measure according to the method described by Gabka and Matsumara (1971). Three measurements were performed between the 5 reference points: tragus, pogonium (soft tissues), lateral corner of the eyes, the angle of the mandible, external corner of the mouth. The sum of the preoperative measurements was the standard of normality for each side. The swelling evaluation was done by subtracting the postoperative measurements by the sum obtained at the preoperative moment (baseline).
Change from baseline mouth opening at 24 hours following the surgery.
Time frame: The measurement was determined in the preoperative period (baseline) and at the period of 24 hours following the surgery.
The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.
Change from baseline mouth opening at 48 hours following the surgery.
Time frame: The measurement was determined in the preoperative period (baseline) and at the period of 48 hours following the surgery.
The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.
Change from baseline mouth opening at 72 hours following the surgery.
Time frame: The measurement was determined in the preoperative period (baseline) and at the period of 72 hours following the surgery.
The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.
Change from baseline mouth opening at 7 days following the surgery.
Time frame: The measurement was determined in the preoperative period (baseline) and at the period of 7 days following the surgery.
The maximum mouth opening was used to assess the level of trismus. The distance between the left upper and lower incisor was measured with a digital caliper and transcribed, in millimeters, for data recording. After verification of the measurements in the postoperative period, the difference in the measurements before and after the surgical procedure was observed, determining the level of trismus.
Change of anxiety state scores using STAI questionnaire at the moment before the preoperative acupuncture and after the acupuncture.
Time frame: The STAI-S questionnaires were applied before the preoperative acupuncture and after acupuncture.
Anxiety was evaluated with the Spielberger State-Trait Anxiety Inventory (STAI) questionnaire, translated and validated to Portuguese by Biaggio et al. (1977). The STAI is a validated questionnaire consisting of two parts, each with 20 questions. One part, STAI-S, evaluates the state of anxiety which is defined as anxiety in response to a situation. The other part, STAI-T, evaluates the anxiety trait, defined by the level of anxiety normally felt by the person. The two parts can be scored from 20 to 80, with the highest values indicating the highest rates of anxiety. Values ≥40 indicate a high level of anxiety and ≥50 as very high.
Change of anxiety state scores using a Visual Analogue Scale (VAS) questionnaire at the moment before the preoperative acupuncture and after the acupuncture.
Time frame: The VAS were applied before the preoperative acupuncture and after acupuncture.
A visual analog scale (VAS) consisted of a 10cm line, without divisions was used. The patients were instructed to mark the level of anxiety at that moment, with the "0" without anxiety and "10", with a high level of anxiety, that was measured with a ruler later.
2 secondary outcomes
Duration of surgery
Time frame: From the time of the initial incision to the time of the final suture.
Number of painkillers tablets
Time frame: By the seventh postoperative day.
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 4 Jun 2018.
- 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.
Anna Catharina V Armond principal investigator
Federal University of Jequitinhonha and Mucuri Valleys
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Tooth Extraction and Molar, Third, run by Federal University of the Valleys of Jequitinhonha and Mucuri.
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 5 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 4 Jun 2018. 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. Some participants in this study may receive a placebo. 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?
Presence and intensity of postoperative pain at 24 hours following the surgery (time frame: The marking was performed at 24 hours postoperatively.). The study lists 13 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 4 Jun 2018.