AnxietyNCT02160028
Pain and Placebo Analgesia. Does Extended Information About Dental Procedures Reduce Pain Induced by Dental Treatment?
A study testing anesthetics and extended information before dental treatment and anesthetics and standard information before dental treatment in people with Anxiety and Odontophobia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Information about the effectiveness of treatment has been found to reduce pain, termed placebo analgesia. In this study it will be investigated whether this finding translates to the dental clinic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Odontophobia
- What is being tested?
- anesthetics and extended information before dental treatment and anesthetics and standard information before dental treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to Jan 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients to be treated for dental caries
- Patients should be able to read and communicate in Norwegian
Who cannot join
- Patients with life threatening diseases
- Patients taking pain killers for other reasons on the day of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain and Placebo Analgesia. A Double Blinded, Randomized, Clinical Study About the Impact of Information About Anesthesia, and the Experience of Pain and Stress During Dental Treatment.
Information about the effectiveness of treatment has been found to reduce pain, termed placebo analgesia. In this study it will be investigated whether this finding translates to the dental clinic. It will be investigated whether information that suggested that minimal pain will be experienced during filling therapy, can reduce the pain associated with that procedure compared to a group that receives standard information. All patients will receive the same amount of anesthesia and similar procedures during filling therapy. It is predicted that extended information should reduce pain, and that the reduction in pain should be associated with a reduction in stress.
- Conditions
- Anxiety, Odontophobia
- Being tested
- anesthetics and extended information before dental treatment, anesthetics and standard information before dental treatment
- Keywords
- Information, Pain, Stress, Fear, Placebo analgesia
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthetics and extended information before dental treatmentOther
The extended information is a comprehensive explanation about what to expect of the treatment and the anesthetic method, phrased in positive words and opening up for questions after information is given.
anesthetics and standard information before dental treatmentOther
The standard information is short and concise, telling in neutral words what to expect.
| Study group | Role | What they receive |
|---|---|---|
| Standard information | Active comparator | This group is given anesthetics and standard information before dental treatment about the anesthetics. Receives: Other: anesthetics and standard information before dental treatment |
| Extended information | Experimental | This group is given anesthetics and extended information before dental treatment about the anesthetics. Receives: Other: anesthetics and extended information before dental treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain
Pain intensity and pain discomfort will be measured by a VAS (Visual Analog Scale). The patients will report their experience of these factors verbally, four times during the treatment session.
Measured: 1 hour
Secondary outcomes (1)
Reduction of stress
Stress is also measured using the VAS, i.e. using the same method as for pain. Stress or sympathetic activation is measured by using scin conductance on fingers (V-Amp (Brain Products, Munich, Germany).
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Tannhelsetjenestens Kompetansesenter Vest, TK Vest, Tannlegesenteret Madlagården, TSMG
- Responsible party
- Sponsor
- Investigators
- Magne A Flaten, phd prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160028
- Sponsor's protocol ID
- 2014/2615/SGK
- Status last verified
- Feb 2017
- First submitted
- 6 Jun 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Placebo Analgesia. A Double Blinded, Randomized, Clinical Study About the Impact of Information About Anesthesia, and the Experience of Pain and Stress During Dental Treatment.
- ClinicalTrials.gov ID
- NCT02160028
- Acronym / sponsor ID
- 2014/2615/SGK
- Conditions
- Anxiety, Odontophobia
- Keywords
- Information, Pain, Stress, Fear, Placebo analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Bergen, Tannhelsetjenestens Kompetansesenter Vest, TK Vest, Tannlegesenteret Madlagården, TSMG
- Study start
- Aug 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Jun 2014 (estimated)
- 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.
Information about the effectiveness of treatment has been found to reduce pain, termed placebo analgesia. In this study it will be investigated whether this finding translates to the dental clinic. It will be investigated whether information that suggested that minimal pain will be experienced during filling therapy, can reduce the pain associated with that procedure compared to a group that receives standard information. All patients will receive the same amount of anesthesia and similar procedures during filling therapy. It is predicted that extended information should reduce pain, and that the reduction in pain should be associated with a reduction in stress.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard information | Active comparator | Other: anesthetics and standard information before dental treatmentThis group is given anesthetics and standard information before dental treatment about the anesthetics. |
| Extended information | Experimental | Other: anesthetics and extended information before dental treatmentThis group is given anesthetics and extended information before dental treatment about the anesthetics. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients to be treated for dental caries
- Patients should be able to read and communicate in Norwegian
Key exclusion criteria (2 listed)
- Patients with life threatening diseases
- Patients taking pain killers for other reasons on the day of 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 |
|---|---|---|
| anesthetics and extended information before dental treatmentThe extended information is a comprehensive explanation about what to expect of the treatment and the anesthetic method, phrased in positive words and opening up for questions after information is given. | Other | Extended information |
| anesthetics and standard information before dental treatmentThe standard information is short and concise, telling in neutral words what to expect. | Other | Standard information |
Primary outcome
Reduction of pain
Time frame: 1 hour
Pain intensity and pain discomfort will be measured by a VAS (Visual Analog Scale). The patients will report their experience of these factors verbally, four times during the treatment session.
1 secondary outcome
Reduction of stress
Time frame: One hour
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 14 Feb 2017.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Magne A Flaten, phd prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anesthetics and extended information before dental treatment and anesthetics and standard information before dental treatment in people with Anxiety and Odontophobia, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 2 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 14 Feb 2017. 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 Norway. 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?
Reduction of pain (time frame: 1 hour). 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 14 Feb 2017.