Efficacy of Hypnosis in Anxiety/Pain Reduction in Children During Pulpotomies

Study Overview
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Brief Summary
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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.

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

Conditions
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Dental Anxiety, Pain

Intervention / Treatment
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* Behavioral: Hypnosis
* Behavioral: Tell, show, do technique


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Tell, show, do technique | Behavioral: Tell, show, do technique<br>* The technique involves verbal explanations of procedures in phrases appropriate to the developmental level of the patient (tell); demonstrations for the patient of the visual, auditory, olfactory, and tactile aspects of the procedure in a carefully defined, nonthreatening setting (show); and then, without deviating from the explanation and demonstration, completion of the procedure (do). Tell-show-do technique is used with communication skills (verbal and nonverbal) and positive reinforcement.<br>|
| Experimental: Intervention<br>Hypnosis. | Behavioral: Hypnosis<br>* Therapeutic technique in which clinicians make suggestions to individuals who have undergone a procedure designed to relax them and focus their minds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Face, Legs, Activity, Cry and Consolability Scale | 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 | Change from score in baseline at score during pulpotomies and after pulpotomies, through study completation average 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental anxiety, Pain, Child, Pediatric dentistry, Hypnosis