Efficacy of Hypnosis in Anxiety/Pain Reduction in Children During Pulpotomies
Primary Purpose
Dental Anxiety, Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypnosis
Tell, show, do technique
Sponsored by
About this trial
This is an interventional treatment trial for Dental Anxiety focused on measuring Dental anxiety, Pain, Child, Pediatric dentistry, Hypnosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control
Intervention
Arm Description
Tell, show, do technique
Hypnosis.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03739346
First Posted
September 11, 2018
Last Updated
November 9, 2018
Sponsor
Alejandra Ramírez Carrasco
1. Study Identification
Unique Protocol Identification Number
NCT03739346
Brief Title
Efficacy of Hypnosis in Anxiety/Pain Reduction in Children During Pulpotomies
Official Title
Efficacy of Hypnosis Compared With Tell/Show/do Technique in Anxiety/Pain Reduction in Children During Pulpotomies
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alejandra Ramírez Carrasco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Pain
Keywords
Dental anxiety, Pain, Child, Pediatric dentistry, Hypnosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
Tell, show, do technique
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Hypnosis.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
Therapeutic technique in which clinicians make suggestions to individuals who have undergone a procedure designed to relax them and focus their minds.
Intervention Type
Behavioral
Intervention Name(s)
Tell, show, do technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Face, Legs, Activity, Cry and Consolability Scale
Description
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
Time Frame
Change from score in baseline at score during pulpotomies and after pulpotomies, through study completation average 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandra Ramírez, Specialist
Phone
+524445823520
Email
lunale_13@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Butrón Téllez-Girón, Master
Phone
+524441741802
Email
poly97bu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Pierdant Pérez, Master
Organizational Affiliation
Universidad Autónoma de San Luis Potosí
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Hypnosis in Anxiety/Pain Reduction in Children During Pulpotomies
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