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

February 12, 2017 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Hafrsfjord, Norway, 4090
        • Tannlegesenteret Madlagården, TSMG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of stress
Time Frame: One hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

University of Bergen
Tannhelsetjenestens Kompetansesenter Vest, TK Vest
Tannlegesenteret Madlagården, TSMG

Investigators

  • Study Director: Magne A Flaten, phd prof, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 12, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/2615/SGK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on anesthetics and standard information before dental treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe