search
Back to results

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
Alejandra Ramírez Carrasco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety focused on measuring Dental anxiety, Pain, Child, Pediatric dentistry, Hypnosis

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 11, 2018
    Last Updated
    November 9, 2018
    Sponsor
    Alejandra Ramírez Carrasco
    search

    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
    Citations:
    PubMed Identifier
    27022303
    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.
    Results Reference
    background
    PubMed Identifier
    20687082
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24320894
    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.
    Results Reference
    background
    PubMed Identifier
    24453440
    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.
    Results Reference
    background
    PubMed Identifier
    28298978
    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.
    Results Reference
    background
    PubMed Identifier
    21197816
    Citation
    Jones LM, Buchanan H. Assessing children's dental anxiety in New Zealand. N Z Dent J. 2010 Dec;106(4):132-6.
    Results Reference
    background
    PubMed Identifier
    25030332
    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.
    Results Reference
    background
    PubMed Identifier
    8687368
    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. doi: 10.1016/0005-7967(96)00015-0.
    Results Reference
    background
    PubMed Identifier
    18243640
    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.
    Results Reference
    background
    PubMed Identifier
    23534317
    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. doi: 10.17796/jcpd.37.2.k84341490806t770.
    Results Reference
    background
    PubMed Identifier
    27445611
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26779081
    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.
    Results Reference
    background
    PubMed Identifier
    28490941
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22341137
    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.
    Results Reference
    background
    PubMed Identifier
    26207651
    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):2132-2151. doi: 10.1097/j.pain.0000000000000305.
    Results Reference
    background
    PubMed Identifier
    28646527
    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(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.
    Results Reference
    background
    PubMed Identifier
    19366409
    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.
    Results Reference
    background
    PubMed Identifier
    25928776
    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.
    Results Reference
    background
    PubMed Identifier
    17683446
    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. doi: 10.1111/j.1469-7610.2007.01759.x.
    Results Reference
    background
    PubMed Identifier
    24891439
    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.
    Results Reference
    background
    PubMed Identifier
    10769980
    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. doi: 10.1080/00207140008410044.
    Results Reference
    background
    PubMed Identifier
    27097858
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs