Pain and Placebo Analgesia. Does Extended Information About Dental Procedures Reduce Pain Induced by Dental Treatment?

Study Overview
=================
Brief 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. 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.

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.

Conditions
-----------------
Anxiety, Odontophobia

Intervention / Treatment
-----------------
* Other: anesthetics and extended information before dental treatment
* Other: anesthetics and standard information before dental treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients to be treated for dental caries Patients should be able to read and communicate in Norwegian Exclusion Criteria: Patients with life threatening diseases Patients taking pain killers for other reasons on the day of treatment
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard information<br>This group is given anesthetics and standard information before dental treatment about the anesthetics. | Other: anesthetics and standard information before dental treatment<br>* The standard information is short and concise, telling in neutral words what to expect.<br>|
| Experimental: Extended information<br>This group is given anesthetics and extended information before dental treatment about the anesthetics. | Other: anesthetics and extended information before dental treatment<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | One hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Information, Pain, Stress, Fear, Placebo analgesia