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

Anxiety Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160028
• Other study ID #: 2014/2615/SGK
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: February 12, 2017
• Start date: August 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Odontophobia

Intervention

Other:
• anesthetics and extended information before dental treatment
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 treatment
The standard information is short and concise, telling in neutral words what to expect.

Locations

Country	Name	City	State
Norway	Tannlegesenteret Madlagården, TSMG	Hafrsfjord

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Tannhelsetjenestens Kompetansesenter Vest, TK Vest, Tannlegesenteret Madlagården, TSMG, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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