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AzTrials

Dental AnxietyNCT03739346

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

A study testing Hypnosis and Tell, show, do technique in people with Dental Anxiety and Pain, run by Alejandra Ramírez Carrasco.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 5 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Dental Anxiety, Pain
What is being tested?
Hypnosis and Tell, show, do technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
20 Nov 2018to Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Patients who have received hypnosis before.

Trial locations and contacts

No sites are listed yet.

Alejandra Ramírez, Specialist contact

+524445823520

lunale_13@hotmail.com

Claudia Butrón Téllez-Girón, Master contact

+524441741802

poly97bu@hotmail.com

About this study

Official title: 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.

Conditions
Dental Anxiety, Pain
Being tested
Hypnosis, Tell, show, do technique
Keywords
Dental anxiety, Pain, Child, Pediatric dentistry, Hypnosis
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypnosisBehavioural

    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 techniqueBehavioural

    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.

Study groups in NCT03739346
Study groupRoleWhat they receive
ControlExperimentalTell, show, do technique
Receives: Behavioral: Tell, show, do technique
InterventionExperimentalHypnosis.
Receives: Behavioral: Hypnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change from score in baseline at score during pulpotomies and after pulpotomies, through study completation average 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2018
  2. Study start20 Nov 2018 (estimated)
  3. Primary completionDec 2018 (estimated)
  4. Study completionFeb 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03739346
Sponsor's protocol ID
CEIFE-032-017
Status last verified
Nov 2018
First submitted
11 Sep 2018
Last updated
13 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27022303

  • 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.

    PubMed 20687082

  • 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.

    PubMed 24320894

  • 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.

    PubMed 24453440

  • 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.

    PubMed 28298978

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

    PubMed 21197816

  • 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.

    PubMed 25030332

  • 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.

    PubMed 8687368

  • 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.

    PubMed 18243640

  • 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.

    PubMed 23534317

  • 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.

    PubMed 27445611

  • 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.

    PubMed 26779081

  • 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.

    PubMed 28490941

  • 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.

    PubMed 22341137

  • 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.

    PubMed 26207651

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis and Tell, show, do technique in people with Dental Anxiety and Pain, run by Alejandra Ramírez Carrasco.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alejandra Ramírez, Specialist (+524445823520, lunale_13@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03739346, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.

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