- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03739346
Efficacy of Hypnosis in Anxiety/Pain Reduction in Children During Pulpotomies
Efficacy of Hypnosis Compared With Tell/Show/do Technique in Anxiety/Pain Reduction in Children During Pulpotomies
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Control
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.
|
Expérimental: Intervention
Hypnosis.
|
Therapeutic technique in which clinicians make suggestions to individuals who have undergone a procedure designed to relax them and focus their minds.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Face, Legs, Activity, Cry and Consolability Scale
Délai: 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 |
Change from score in baseline at score during pulpotomies and after pulpotomies, through study completation average 3 months.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Mauricio Pierdant Pérez, Master, Universidad Autonoma de San Luis Potosí
Publications et liens utiles
Publications générales
- Appukuttan DP. Strategies to manage patients with dental anxiety and dental phobia: literature review. Clin Cosmet Investig Dent. 2016 Mar 10;8:35-50. doi: 10.2147/CCIDE.S63626. eCollection 2016.
- Armfield JM, Heaton LJ. Management of fear and anxiety in the dental clinic: a review. Aust Dent J. 2013 Dec;58(4):390-407; quiz 531. doi: 10.1111/adj.12118.
- Najafpour E, Asl-Aminabadi N, Nuroloyuni S, Jamali Z, Shirazi S. Can galvanic skin conductance be used as an objective indicator of children's anxiety in the dental setting? J Clin Exp Dent. 2017 Mar 1;9(3):e377-e383. doi: 10.4317/jced.53419. eCollection 2017 Mar.
- Al-Harasi S, Ashley PF, Moles DR, Parekh S, Walters V. Hypnosis for children undergoing dental treatment. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007154. doi: 10.1002/14651858.CD007154.pub2.
- Nigam AG, Marwah N, Goenka P, Chaudhry A. Correlation of general anxiety and dental anxiety in children aged 3 to 5 years: A clinical survey. J Int Oral Health. 2013 Dec;5(6):18-24. Epub 2013 Dec 26.
- Jones LM, Buchanan H. Assessing children's dental anxiety in New Zealand. N Z Dent J. 2010 Dec;106(4):132-6.
- Han HR. Measuring anxiety in children: a methodological review of the literature. Asian Nurs Res (Korean Soc Nurs Sci). 2009 Jun;3(2):49-62. doi: 10.1016/S1976-1317(09)60016-5.
- Litt MD. A model of pain and anxiety associated with acute stressors: distress in dental procedures. Behav Res Ther. 1996 May-Jun;34(5-6):459-76. doi: 10.1016/0005-7967(96)00015-0.
- Wood C, Bioy A. Hypnosis and pain in children. J Pain Symptom Manage. 2008 Apr;35(4):437-46. doi: 10.1016/j.jpainsymman.2007.05.009. Epub 2008 Feb 4.
- Jain AA, Yeluri R, Munshi AK. Measurement and assessment of pain in children--a review. J Clin Pediatr Dent. 2012 Winter;37(2):125-36. doi: 10.17796/jcpd.37.2.k84341490806t770.
- Kolosovas-Machuca ES, Martinez-Jimenez MA, Ramirez-GarciaLuna JL, Gonzalez FJ, Pozos-Guillen AJ, Campos-Lara NP, Pierdant-Perez M. Pain Measurement through Temperature Changes in Children Undergoing Dental Extractions. Pain Res Manag. 2016;2016:4372617. doi: 10.1155/2016/4372617. Epub 2016 Apr 26.
- Seinfeld S, Bergstrom I, Pomes A, Arroyo-Palacios J, Vico F, Slater M, Sanchez-Vives MV. Influence of Music on Anxiety Induced by Fear of Heights in Virtual Reality. Front Psychol. 2016 Jan 5;6:1969. doi: 10.3389/fpsyg.2015.01969. eCollection 2015.
- Ramirez-Carrasco A, Butron-Tellez Giron C, Sanchez-Armass O, Pierdant-Perez M. Effectiveness of Hypnosis in Combination with Conventional Techniques of Behavior Management in Anxiety/Pain Reduction during Dental Anesthetic Infiltration. Pain Res Manag. 2017;2017:1434015. doi: 10.1155/2017/1434015. Epub 2017 Apr 11.
- Bai J, Hsu L, Tang Y, van Dijk M. Validation of the COMFORT Behavior scale and the FLACC scale for pain assessment in Chinese children after cardiac surgery. Pain Manag Nurs. 2012 Mar;13(1):18-26. doi: 10.1016/j.pmn.2010.07.002. Epub 2011 Feb 24.
- Crellin DJ, Harrison D, Santamaria N, Babl FE. Systematic review of the Face, Legs, Activity, Cry and Consolability scale for assessing pain in infants and children: is it reliable, valid, and feasible for use? Pain. 2015 Nov;156(11):2132-2151. doi: 10.1097/j.pain.0000000000000305.
- Raslan N, Masri R. A randomized clinical trial to compare pain levels during three types of oral anesthetic injections and the effect of Dentalvibe(R) on injection pain in children. Int J Paediatr Dent. 2018 Jan;28(1):102-110. doi: 10.1111/ipd.12313. Epub 2017 Jun 24.
- Johansson M, Kokinsky E. The COMFORT behavioural scale and the modified FLACC scale in paediatric intensive care. Nurs Crit Care. 2009 May-Jun;14(3):122-30. doi: 10.1111/j.1478-5153.2009.00323.x.
- Elkins GR, Barabasz AF, Council JR, Spiegel D. Advancing Research and Practice: The Revised APA Division 30 Definition of Hypnosis. Am J Clin Hypn. 2015 Apr;57(4):378-85. doi: 10.1080/00029157.2015.1011465.
- Gold JI, Kant AJ, Belmont KA, Butler LD. Practitioner review: clinical applications of pediatric hypnosis. J Child Psychol Psychiatry. 2007 Aug;48(8):744-54. doi: 10.1111/j.1469-7610.2007.01759.x.
- Birnie KA, Noel M, Parker JA, Chambers CT, Uman LS, Kisely SR, McGrath PJ. Systematic review and meta-analysis of distraction and hypnosis for needle-related pain and distress in children and adolescents. J Pediatr Psychol. 2014 Sep;39(8):783-808. doi: 10.1093/jpepsy/jsu029. Epub 2014 Jun 2.
- Milling LS, Costantino CA. Clinical hypnosis with children: first steps toward empirical support. Int J Clin Exp Hypn. 2000 Apr;48(2):113-37. doi: 10.1080/00207140008410044.
- Oberoi J, Panda A, Garg I. Effect of Hypnosis During Administration of Local Anesthesia in Six- to 16-year-old Children. Pediatr Dent. 2016 Mar-Apr;38(2):112-5.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CEIFE-032-017
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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