Efficacy of Hypnosis in Anxiety/Pain Reduction in Children During Pulpotomies
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| ClinicalTrials.gov Identifier: NCT03739346 |
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Recruitment Status : Unknown
Verified November 2018 by Alejandra Ramírez Carrasco, Universidad Autonoma de San Luis Potosí.
Recruitment status was: Not yet recruiting
First Posted : November 13, 2018
Last Update Posted : November 13, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dental Anxiety Pain | Behavioral: Hypnosis Behavioral: Tell, show, do technique | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of Hypnosis Compared With Tell/Show/do Technique in Anxiety/Pain Reduction in Children During Pulpotomies |
| Estimated Study Start Date : | November 20, 2018 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | February 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Control
Tell, show, do technique
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Behavioral: Tell, show, do technique
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. |
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Experimental: Intervention
Hypnosis.
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Behavioral: Hypnosis
Therapeutic technique in which clinicians make suggestions to individuals who have undergone a procedure designed to relax them and focus their minds. |
- 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
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| Ages Eligible for Study: | 5 Years to 7 Years (Child) |
| Sexes Eligible for Study: | 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.
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): NCT03739346
| Contact: Alejandra Ramírez, Specialist | +524445823520 | lunale_13@hotmail.com | |
| Contact: Claudia Butrón Téllez-Girón, Master | +524441741802 | poly97bu@hotmail.com |
| Study Director: | Mauricio Pierdant Pérez, Master | Universidad Autónoma de San Luis Potosí |
| Responsible Party: | Alejandra Ramírez Carrasco, Principal Investigator, Universidad Autonoma de San Luis Potosí |
| ClinicalTrials.gov Identifier: | NCT03739346 |
| Other Study ID Numbers: |
CEIFE-032-017 |
| First Posted: | November 13, 2018 Key Record Dates |
| Last Update Posted: | November 13, 2018 |
| Last Verified: | November 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Dental anxiety Pain Child Pediatric dentistry Hypnosis |
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Anxiety Disorders Mental Disorders |