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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03739346
• Other study ID #: CEIFE-032-017
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: February 2019

Study information

• Verified date: November 2018
• Source: Universidad Autonoma de San Luis Potosí
• Contact: Alejandra Ramírez, Specialist
• Phone: +524445823520
• Email: lunale_13[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety
• Pain

Intervention

Behavioral:
• Hypnosis
Therapeutic technique in which clinicians make suggestions to individuals who have undergone a procedure designed to relax them and focus their minds.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alejandra Ramírez Carrasco

References & Publications (22)

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. Review. Update in: Cochrane Database Syst Rev. 2017 Jun 20;6:CD007154. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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):2132-51. doi: 10.1097/j.pain.0000000000000305. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Jones LM, Buchanan H. Assessing children's dental anxiety in New Zealand. N Z Dent J. 2010 Dec;106(4):132-6. — View Citation

Kolosovas-Machuca ES, Martínez-Jiménez MA, Ramírez-GarcíaLuna JL, González 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. — View Citation

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. Review. — View Citation

Milling LS, Costantino CA. Clinical hypnosis with children: first steps toward empirical support. Int J Clin Exp Hypn. 2000 Apr;48(2):113-37. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ramírez-Carrasco A, Butrón-Téllez Girón C, Sanchez-Armass O, Pierdant-Pérez 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. — View Citation

Raslan N, Masri R. A randomized clinical trial to compare pain levels during three types of oral anesthetic injections and the effect of Dentalvibe(®) on injection pain in children. Int J Paediatr Dent. 2018 Jan;28(1):102-110. doi: 10.1111/ipd.12313. Epub 2017 Jun 24. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.