NEED FOR STUDY

                 Dental fear and anxiety (DFA) are frequently associated with the dental procedure which requires the use of local anaesthesia for the management of pain in children¹. The prevalence of dental anxiety in children and adolescents ranges from 5.7% to 20.2%.² Fear and anxiety related behaviour during the treatment has long been recognized as the most difficult aspect of patient management and the condition negatively impacts oral health related quality of life in children and adults.³

                To perform oral health care safely and efficiently both pharmacological and nonpharmacological behavioural management are used in children.Tell-show-do technique has shown to be the most frequently used technique, with high parental acceptance and is the safest method among the non-pharmacological techniques, but there are  limited studies evaluating  this method effectiveness  during invasive procedure like local anaesthesia.⁴ The cognitive-behavioural based approaches are recent non-pharmacologic method for managing pain and distress in children which also encompasses mindfulness.

                 Mindulness is “the self-regulation of attention, so that it is maintained on immediate experience thereby allowing for increased recognition of mental events in the present moment” and “the adoption of a particular orientation toward one’s experiences in the present moment, an orientation that is characterized by curiosity, openness, and acceptance.” This mindful attention technique targets worries and anxiety, which are related to pain and related outcomes^{4 .}  

                        Mindful  attention technique have been studied in pediatrics for the management of acute pain experience. Hence, this study was taken to evaluate the effectiveness of mindful attention on dental fear anxiety and pain in children during  local anaesthesia.  

RESEARCH QUESTION: Whether mindful attention technique could decrease the dental fear anxiety level, pain perception and thus enhance the acceptance of local anaesthesia than Tell-Show-Do technique.

NULL HYPOTHESIS: Mindful attention technique will not decrease the dental fear anxiety level, pain perception and thus decrease the acceptance of local anaesthesia than Tell-ShowDo technique.

RESEARCH HYPOTHESIS: Mindful attention technique would decrease the dental fear anxiety level, pain perception and thus enhance the acceptance of local anaesthesia  than Tell-Show-Do technique.

6.2 REVIEW OF LITERATURE:

                    A randomised between subject control trial was conducted among 82 children aged 10 to 14 to examine the effectiveness of mindful attention on Cold pressure pain experience(experimental pain) compared to guided imagery. It was concluded that mindful attention was succesfull in helping children focus attention on experimental pain without increasing pain intensity or decreasing tolerance compared to guided imagery¹.

                A systematic review on Brief Mindfulness-Based Interventions (BMBI) for acute and chronic pain revealed that BMBI delivered in a particular format-by a provider and lasting more than 5 minutes showed some promise in the management of acute pain. It was concluded that more rigorous large scale studies

 conducted with pain  populations are needed before unequivocally recommending BMBI as a first-line treatment for acute and chronic pain². 

                  A single-site, Two-arm, parallel-group randomised control trial was aimed to examine the effects of a mindfulness intervention compared to

 unfocused attention group among 150 parent and children in the age group of 7 to 12 years before child venipuncture. 61 parent-child dyad have participated

 till march 2020. Child pain related outcomes as reported  by parents and children post venipuncture would be assessed to evaluate the success of mindfulness

 intervention³.

                   Retrospective, Cross-sectional study was conducted to assess the behaviour of 328(age 2 to 14 years) children with Wong Baker rating scale during dental visits and to determine the effect of behaviour management technique on children. it was concluded that behaviour was enhanced with every subsequent visits and techniques like live modelling and Tell-Show- Do were very effective in modifying children behaviour⁴.    

OBJECTIVES OF THE STUDY

1. To compare and evaluate the Dental Fear Anxiety before and after local anaesthesia procedure following  mindful attention technique  and Tell Show Do technique using self assessment scale, Childrens Fear survey Schedule – Dental Subscale(CFSS-DS) and physiological parameters- oxygen saturation and pulse rate using pulse oximeter.

2.To compare and evaluate the pain following mindful attention technique and Tell Show Do technique immediately after local anaesthesia procedure using Wong-Baker Facial Rating Scale(W-BFRS).

 Materials and methods

7.1 Source of data: Healthy children in the age group of 9-12 years visiting the department of Pediatrics and Preventive Dentistry, Government Dental College and Research Institute requiring any dental treatment under local anaesthesia will be selected for the study. After obtaining the written consent inform from the parents, 44 children will be recruited to the study based on the inclusion and exclusion criteria. 

Study Design

The study is a participant blinded, Randomised between- subjects clinical trial.

Study Period

Group I:

            Children in the group I would be given brief information about the carry out of the mindful attention technique in the child preference language(kannada/hindi/english). After this information, just before local anaesthesia procedure children would close their eyes and will listen to audio recording(english, hindi, kannada) of the mindful attention instructions through the headphone approximately for 10 minutes. After the removal of the headphone topical anaesthesia will be applied to the soft tissue target of needle penetration for 1 minute, followed by administration of local anaesthesia.

Group II:

            Children in the group II the local anaesthesia procedure will be demonstrated by TSD ( Tell -Show-Do) technique . This technique will involve verbal explanations related to the local anaesthesia procedure (TELL) after which the patient will be demonstrated the procedure using  needle with a cap, (SHOW)

 and then without deviating from the explanation and demonstration completion of the local anaesthesia procedure (DO). Topical anaesthesia will be applied to

 the soft tissue target of needle penetration for 1minute, followed by administration of Local anaesthesia.  

             Techniques of local anaesthesia procedure, arch type and the type of dental procedures will be recorded. Assessment of  DFA and pain will be recorded by the children in both the groups immediately after local anaesthesia using CFSS-DS, pulse oximeter  and WBFRS. Children will be asked to grade their pain using W-BFRS for local anaesthesia administration with the following verbatim. “ Here each face is a person who feels happy because he has no pain or sad because he has lot of pain. Choose the face that best describes what you are feeling.” 

VALIDITY OF THE MINDFUL ATTENTION INSTRUCTION SCRIPT

Purpose: Mindful attention instruction script in english has been used in Canadian children in the age group of 7 to 12 years during venipuncture procedure. The use of same script to our study subjects during local anaesthesia procedure.

Step 1: Translation of the scripts:

    Majority of the children attending to the department of paediatric and preventive dentistry are children who can read and understand Kannada, English and Hindi. Hence the original english script was translated to kannada and hindi language by the subject expert without changing the content and meaning of the script. 

Step 2: Pre-testing the script for target group:

   Evaluation of the scripts were made through four questionnaire regarding understanding of the content of the script by 10% of the sample size. Children aged

 9 to 12 visiting the department were selected after obtaining the consent from the parents. Children were made to sit comfortably in the chair and intructions

 regarding the mindful attention script were given to the children. The script was read for 10 minutes and they were made to evaluate the script through

 questionnaires. Evaluation showed that few words in the scripts were difficult to understand. Based on this, difficult words were changed to the simpler words and evaluated again with language experts, and also to the target group and subject experts review.

Step 3: Validity of the scripts by expert:

            The possible Content Validity Index(CVI) scores can range from 0 to 1. Calculated CVI was found to be 0.90 which means there is 90% agreement among the subject experts on the content validity of the script. Hence knowing the content validation the script was used in the study.

ASSESSMENT TOOL 1

Children’s fear survey schedule-dental subscale(CFSS-DS): Assessed before and after the procedure

1. Dentists	1 2 3 4 5
2. Doctors
3. Injections
4. Having somebody examine the mouth
5. Having to open your mouth
6. Having a stranger touch you
7. Having somebody look at you
8. The dentist drilling
9. the sight of the dentist drilling
10. The noise of the dentist drilling
11. Having someone put instrument in your mouth
12. Choking
13. Having to go to the hospital
14. People in white uniforms
15. Having the nurse clean your teeth
The anxiety is marked in 5 point anxiety scale:
1. Not afraid at all
2. Very afraid
3. Moderate fear
4. Pretty much afraid
5. very much afraid

The CFSS�’DS consists of 15 items related to different aspects of dental treatment which were scored as follows: Not afraid = 1; a little afraid = 2; fairly afraid = 3; quite afraid = 4; and very afraid = 5. Total scores thus ranged from 15 to 75. Seventy�’five indicating maximal fear. Children with CFSS�’DS ≥38 were defined as dentally anxious.

ASSESSMENT TOOL 2

Pulse rate and oxygen saturation: Pulse rate and oxygen saturation is assessed using Pulse

Oximeter. Normal reference range for pulse rate: 60-110bpm for 6 to 12 years

                                                                               60 -100bpm for >12  years

 ASSESSMENT TOOL 3

 The Wong–Baker Faces Pain Rating Scale (W-BFRS) : Assessed after the administration of local anaesthesia.         

The Wong–Baker Faces Pain Rating Scale (W-BFRS) will be used for subjective evaluation of pain immediately after the injection of local anesthetic and after the pulp therapy procedure. This scale shows good construct validity as a self-report pain measure. It measures the unpleasantness or affective dimension of a child’s pain experience after

injection and is used in children aged 3–17 years. The child is shown a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numerical value. Before starting any procedure, each child will be introduced to W-BFRS with adequate instructions so that they will be able to give a score after the procedure although the child will be blinded about the study. The W-BFRS consisted of scores and corresponding pictorial representation with smileys. A score of 0 represents no hurt, 2 hurts little bit, 4 hurts little more,6 hurts even more,8 hurts whole lot, 10 hurts worst. 0-2 is considered mild pain, 4-6 moderate & 8-10 severe pain. Mild or no pain is to be considered as success.

STATISTICAL ANALYSIS

Data will be analysed using the statistical package SPSS 22.0 (SPSS Inc., Chicago, IL) and level of significance will be set at p<0.05. Descriptive statistics will be performed to assess the mean and standard deviation of the respective groups. Normality of the data will be assessed using Shapiro Wilkinson test. Inferential statistics to find out the difference between and within the groups will be done using Independent t test /Manwhitney U test and Paired t test/ Wilcoxon sign rank test.

CHILD MINDFULNESS SCRIPT

During the next few minutes, you will be guided through an activity that you can use before and during your needle. When you’re ready, sit still in your chair. Straighten your back, and take your time to sit up straight and comfortably. Close your eyes and take a slow, deep breath…in through your nose… 1,2,3,4,5. Now blow out though your nose…1,2,3,4,5. Fill your lungs again, breathing through your nose…1,2,3,4,5 and out through your nose…1,2,3,4,5. Good, as you continue to breathe deeply, allow your body to relax into your chair. Now imagine any of your worries about your needle as a cloud in the sky. Look at this cloud closely. Can you see any details? There’s no right or wrong answer. What size is it? Is it gray and stormy looking? Or maybe it’s white and fluffy. Does the look of the cloud make you feel anything in your body? Do you feel those feelings in a particular place? Can you lay your hand where those sensations are? Sometimes our clouds make us feel scared, or maybe even angry. Whatever you’re noticing, just allow yourself to be aware of it. There’s no need to change or judge your thoughts—they’re all ok to have. Now bring your attention back to your cloud. I want to remind you that your cloud is real and important, and it’s something to pay attention to—just like all of your emotions. As you sit and watch it float by in the sky, has your cloud changed shape or color? Is it moving quickly or does it seem to stay in one place? Like any cloud you see in the sky, your cloud may seem to sit still and linger at times. But if you continue to watch it, you’ll notice that it’s actually floating along and will eventually drift out of sight. As you are taking deep breaths and blowing out, you might imagine that you’re blowing your stormy clouds away. With a little time, every cloud moves on and then new clouds—just like new feelings—come into view. That’s what I want you to imagine now—your cloud has moved on from your view and new clouds are gently drifting in. They look and feel different from the one that was just there. There are many of them filling the sky in front of you, some gray and dark, some wispy and white, and there’s plenty of blue sky as well. When you get your needle, focus on your breathing and imagine blowing away any stormy clouds that come up. Notice how when the clouds pass by there is blue sky behind them. When you are ready, open your eyes and remove your headphones.

REFERENCES: 

1) Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent.

2)Baakdah RA, Turkistani JM, Al-Qarni AM, Al-Abdali AN, Alharbi HA, Bafaqih JA et al. Pediatric dental treatments with pharmacological and non-pharmacological interventions: a cross-sectional study. BMC Oral Health. 

3) Moline RL, Chambers C, McMurtry CM. Study protocol for a randomized controlled trial of a child and parent mindfulness intervention for pediatric venipuncture. Paediatr Neonatal Pain. 

4) Petter M, Chambers CT, MacLaren Chorney J. The effects of mindfulness-based attention on cold pressor pain in children. Pain Res Manag. 

5)  PALS Algorithms 2021 (Pediatric Advanced Life Support). 

6) Yusoff, Muhamad Saiful Bahri. (2019). ABC of Content Validation and Content Validity Index Calculation. Education in Medicine Journal. 

7)  Grant JS, Davis LL. Selection and use of content experts for instrument development. Res Nurs Health.