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

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ClinicalTrials.gov Identifier: NCT02160028
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : February 14, 2017
Sponsor:
Collaborators:
University of Bergen
Tannhelsetjenestens Kompetansesenter Vest, TK Vest
Tannlegesenteret Madlagården, TSMG
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Anxiety Odontophobia Other: anesthetics and extended information before dental treatment Other: anesthetics and standard information before dental treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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.
Study Start Date : August 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160028


Locations
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Norway
Tannlegesenteret Madlagården, TSMG
Hafrsfjord, Norway, 4090
Sponsors and Collaborators
Norwegian University of Science and Technology
University of Bergen
Tannhelsetjenestens Kompetansesenter Vest, TK Vest
Tannlegesenteret Madlagården, TSMG
Investigators
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Study Director: Magne A Flaten, phd prof Norwegian University of Science and Technology
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02160028    
Other Study ID Numbers: 2014/2615/SGK
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Keywords provided by Norwegian University of Science and Technology:
Information
Pain
Stress
Fear
Placebo analgesia
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs