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

Not Applicable

• Conditions: Pain; Dental Anxiety
• Interventions: Behavioral: Hypnosis; Behavioral: Tell, show, do technique

• Registration Number: NCT03739346
• Lead Sponsor: Alejandra Ramírez Carrasco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-11
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-09
• Last Update Submitted: 2018-11-09
• Study First Posted: 2018-11-13
• Last Update Posted: 2018-11-13
• Study Start: 2018-11-20
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Hypnosis	Hypnosis.
Control	Tell, show, do technique	Tell, show, do technique

Primary Outcome Measures

Name	Time	Method
Face, Legs, Activity, Cry and Consolability Scale	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