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Clinical Trials/NCT03739346
NCT03739346UnknownNot Applicable

Efficacy of Hypnosis Compared With Tell/Show/do Technique in Anxiety/Pain Reduction in Children During Pulpotomies

Alejandra Ramírez Carrasco0 sites60 target enrollmentStarted: November 20, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Primary Endpoint
Face, Legs, Activity, Cry and Consolability Scale

Study Overview

Brief Summary

Anxiety and pain are emotions that the child often experiences in the dental office, generating the appearance of negative, uncooperative and even disruptive behaviors during the treatment; these make it difficult for dental care and the possibility of establishing a relationship of trust between the pediatric dentist and the patient. The pediatric dentist must promote a positive attitude of the child throughout the dental treatment, keep the child calm and avoid feeling pain is essential at each appointment.

When carrying out dental treatments that are more invasive or painful for the patient, such as pulpotomies, it is difficult to distinguish and separate anxiety from pain.

In this project, anxiety/pain will be managed as a whole, to assess it with the same scale, and to correlate the scores obtained with the variations in skin conductance and heart rate, before, during and after perform pulpotomies in children.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
5 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Without previous dental experiences, patients with clinical and radiographic indication of pulpotomy in at least one temporary inferior molar, clinically healthy patients, patients whose parents accept entry into the study and who sign the informed consent.

Exclusion Criteria

  • Patients who have received hypnosis before.

Arms & Interventions

Control

Experimental

Tell, show, do technique

Intervention: Tell, show, do technique (Behavioral)

Intervention

Experimental

Hypnosis.

Intervention: Hypnosis (Behavioral)

Outcomes

Primary Outcomes

Face, Legs, Activity, Cry and Consolability Scale

Time Frame: Change from score in baseline at score during pulpotomies and after pulpotomies, through study completation average 3 months.

A measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. Each category is scored on the 0-2 scale which results in a total score of 0-10. 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Alejandra Ramírez Carrasco
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Alejandra Ramírez Carrasco

Principal Investigator

Universidad Autonoma de San Luis Potosí

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