1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [tanishagambhir96@gmail.com].
   


6. For how long will this data be available start date provided 15-10-2024 and end date provided 15-06-2025?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

TITLE: Effects of pre-procedural behaviour guidance using Video based Intervention for reducing anxiety during restorative dental care in children : A Randomized Controlled trial.

 BACKGROUND: 

  Anxiety is an increased response to a potential threat or danger. Anxiety may occur in response to a real situation but can also occur when no underlying cause is involved. Dental anxiety involves a play of multiple variables and can be either objective or subjective in nature. Previous bad dental experiences tend to increase the prevalence of anxiety among pediatric patients. Anxiety is one of the biggest barriers to providing dental care in children. It leads to increased chair time and compromises on the efficiency of the practitioner in providing appropriate dental treatment. Several meta-analyses have shown that technology can enhance learning^1,2 and multiple studies have shown that video, specifically, can be a highly effective educational tool^3,4. Thus video intervention can be used to direct children towards showing appropriate behavior during dental appointments. The various domains of behavior guidance explored are modeling, desensitization, distraction. A recent study⁶ aimed to explore if video modeling can reduce the level of dental anxiety and increase the patient’s acceptance of the nasal mask usage for children receiving dental treatment using inhalation sedation (IS). The level of anxiety was recorded before and after watching the video on the Abeer Children Dental Anxiety Scale and each child’s ability to cope with the subsequent procedure was assessed on the visual analogue scale. It was observed that Children with video intervention had significantly less anxiety after watching the video than those in the control group. Since dental anxiety is a complex behaviour, it was planned in the present study to explore effects of a systematically developed video intervention in pre-procedural behavior guidance during restorative dental care in children.

ALTERNATE  HYPOTHESIS: A systematically developed video based intervention as pre-procedural behavior guidance method can reduce anxiety for restorative care in school going children in dental office as compared to no such video intervention.

AIM:   To evaluate the efficacy of a video based intervention as pre-procedural behavior guidance method to reduce procedural anxiety for restorative care in school going children in dental office.

 OBJECTIVES:

 PRIMARY

To develop a video based intervention for pre-procedural reduction of dental anxiety in school going children aged 5-10 years (early mixed dentition period) for restorative care in dental office.

To evaluate the effect of developed video intervention for pre-procedural reduction of dental anxiety in school going children aged 5-10 years (early mixed dentition period) for restorative care in dental office.

SECONDARY: 

To compare the effect of the video intervention group with the control group of participants with similar baseline behavior characteristics and restorative treatment needs .

METHODOLOGY:

Study Design: The present study is planned as two phases. Phase 1 shall be an exploratory phase. Phase 2 is planned as a randomized controlled clinical trial. Both phases will be conducted in the Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, King George’s Medical University in Lucknow, Uttar Pradesh. The study will be started only after the ethical approval by the Institutional Ethical Committee of King George’s Medical University, Lucknow. 

Study Setting- The study will be conducted in Post-Graduate Clinic, Department of Paediatric and Preventive Dentistry, Faculty of Dental Sciences, King George’s Medical University, Lucknow, Uttar Pradesh.

PHASE 1: 

Needs assessment or problem analysis shall be done by interviews with parents of children having similar participant characteristics (phase 1 participants) as defined in inclusion and exclusion criteria of Phase 2 to identify how and what needs to be changed for managing anxiety of these participants in dental office for restorative care. Parents giving consent for interviews, participants similar to phase 2, Dental health care professionals involved in the treatment of such participants shall be interviewed.

Identification of parents of phase 1 participants’ beliefs would be done from the interviews so that video based intervention to manage dental anxiety in restorative care can be developed.

Selection of content of video intervention shall be done to match the identified beliefs aggregate, and translate these into practical application, that is the video content.

Development of video based intervention based on identified beliefs in Phase 1 shall be done in collaboration with a hired third party professional.

PHASE 2:

Planning for implementation

Participants Inclusion criteria:

Children of any gender in the age group 5-10 years, visiting Department of Paediatric and Preventive Dentistry, FODS, KGMU, Lucknow, UP; shall be screened for following inclusion criteria.

Patients with moderate caries lesions (classified under merged ICDAS codes⁵ requiring operative care. 

Patients categorized under Frankel’s negative and positive behavior categories.

Patients with no history of previous dental office visits.

Patients whose parents give informed consent for participation.

Participants Exclusion criteria:

Patients with special health care needs.

Patients with Extensive carious lesions requiring pulp therapy or dental extractions

Patients with only initial carious lesions

Pediatric patients finally fulfilling all inclusion and exclusion criteria shall be enrolled in the study as participants. All participants shall be randomly assigned to one of the following groups-

Group I (Control)  - Patients given pre-procedural behavior guidance without video intervention.

Group II (Experimental)- Patients given pre-procedural behavior guidance with video intervention.

Sample size:

Sample Size at 90% Power

Sample size was calculated on the basis of proportion of no change in the Dental anxiety score after applying the technique in experimental and control groups using the formula:

Where p₁ = 0.22 (22.0%) proportion of no change in the Dental anxiety score after applying the technique in experimental group

p₂ = 0.778 (78.1%) proportion of no change in the Dental anxiety score after applying the technique in control group.⁶

e = 1.25(p₂ – p₂), the proportion difference considered to be clinically significant

Type I error, α=5% ⁶

Type II error β=10% for detecting results with power of study 90%

The sample size is n = 42 each group

Randomization:

A block randomization process shall be followed for allocating participants into control or experimental groups. This involves recruiting participants in short blocks and ensuring that one-half of the participants within each block are allocated to “Group I” and the remaining one half to “Group II” within each block to obtain the different combinations. Blocks of ‘Four’ shall be used to allocate to Group I and II respectively.

Procedure:

A baseline data collection will be done before the intervention to determine the domain of dental anxiety in children using Frankel Behaviour classification⁹ All participants finally enrolled in the study shall be allocated to Control or Experimental groups using Block randomization. The parent/ guardian will be explained about the study in detail in a language well understood by them and written consent to be taken for the same. 

In the first appointment, no dental procedures will be carried out on the patient and pre-appointment behavioral guidance will be carried out either with or without video intervention depending on the group to which the patient belongs (Control/Experimental).

The intervention shall be delivered by a single investigator to avoid procedural and examiner bias. The restorative procedure shall be performed by the same investigator. The order of instructions shall be kept identical for all the groups. 

Each participant shall be interviewed after the procedure regarding the feelings during the procedure and possible triggers/reasons for any anxiety. The questions of the interview shall be planned in consultation with the Psychiatry expert.

Evaluation of intervention:

The outcomes shall be measured by observers independent of performing restorative care or delivering Video intervention. A video recording of each patient during the restorative procedure after pre appointment behavior guidance will be recorded to note the facial expressions of the patient and sent to observers for evaluation. 

OUTCOMES:

Subjective measures: These outcome measures shall be recorded with the help of recorded videos by two independent observers.

Change in anxiety scores using Venham Picture Test both pre and post intervention·

Pain perception by participants during restorative care: Wong-Baker FACES Pain Rating Scale post intervention.

Post intervention assessment of video recording by an observer with help of modified YPAS anxiety scale(Annexure-1)

Objective measures: These outcome measures shall be recorded by two independent observers.

Change in Oxygen saturation (SpO2) post-intervention

Change in Heart rate post-intervention

Qualitative outcomes:

Qualitative data shall be collected from the interviews of Parents, participants and Dental health care professionals in phase 1.

Qualitative data shall also be collected from Phase 2 participants interviews.

DATA MANAGEMENT AND ANALYSIS:

Continuous variables conforming to a normal distribution will be expressed as mean ± standard deviation. Counting data will be expressed as number and percentages. The independent-samples t-test will be used for inter-group analysis of quantitative data. The χ2 test will used to find association between study variables. Logistic regression analysis and other appropriate statistical tests will be used to estimate risk factors etc. In all of the statistical analyses, P < 0.05 will be considered to be statistically significant. SPSS latest available version and MS Excel will be used for statistical analysis of the data.

Qualitative data extracted from interviews of phase1 and phase 2 interviews shall be subjected to thematic analysis till the point of data saturation. The themes from both phases of the study shall be compared qualitatively.

REVIEW OF LITERATURE:

  Al-Namankany(2015) investigated the effect of video modeling on the level of dental anxiety and patient’s acceptance of the nasal mask usage for children receiving dental treatment using inhalation sedation (IS)^6. They observed increased acceptance and reduced anxiety.

Vidyavathi H. Patil et al(2017) evaluated the effectiveness of dental apps in the management of child’s anxiety and behavior and found that The mobile dental app was found to be very useful in the dental setup to reduce the fear and anxiety of the pediatric patients⁸

Al-Halabi et al(2018)evaluated the effectiveness of two different audiovisual distraction techniques, e.g. audio-visual (AV) eyeglasses – virtual reality box (VR Box) or a Tablet) in the management of anxious pediatric patients during inferior alveolar nerve block (IAN)7. They observed that Distraction using video shown on tablet device was the best in relieving dental anxiety and pain during IAN block. Although using ‘VR Box’ had no added advantage in a majority of children, ‘VR Box’ was more acceptable in older patients (8- 10 years) than younger patients and gave the children some exciting experiences which may lead to far better behavior in the next dental visits.

Harris et al (2023) concluded that complex intervention development involves an iterative rather than sequential process of combining theory, empirical work and user involvement. Interventions to change behaviour in dental office is also one such complex behaviour requiring complex interventions for development. Similar attempts  has been made by Harris et al for interventions targeted to to reduce inequalities in planned dental visiting.¹⁰

REFERENCES

Means, B., Toyama, Y., Murphy, R., Bakia, M., & Jones, K. (2010). Evaluation of Evidence-Based Practices in Online Learning: A Meta-analysis and Review of Online Learning Studies. US DepartmentofEducation.https://www2.ed.gov/rschstat/eval/tech/evidence-based-practices/finalreport.pdf 

2. Schmid RF, Bernard RM, Borokhovski E, Tamim RM, Abrami PC, Surkes MA, Wade CA, Woods J. The effects of technology use in postsecondary education: a meta-analysis of classroom applications. Comput Educ. 2014;72:271–291.

3.Stockwell BR, Stockwell MS, Cennamo M, Jiang E. Blended Learning Improves Science Education. Cell. 2015 Aug;162(5):933-936. DOI: 10.1016/j.cell.2015.08.009. PMID: 26317458. 

4. Allen WA, Smith AR. Effects of video podcasting on psychomotor and cognitive performance, attitudes and study behavior of student physical therapists. Innov Educ Teach Int. 2012;49:401–414. 

5. NB Pitts and KR Ekstrand on behalf of the ICDAS Foundation International Caries Detection and Assessment System (ICDAS) and its International    Caries Classification and Management System (ICCMS) - methods for staging of the caries process and enabling dentists to manage caries. Community Dent Oral Epidemiol 2013; 41; e41–e52

Al-Namankany • Petrie • P. - Ashley Video modelling for     reducing anxiety related to the use of nasal masks place it for inhalation sedation: a randomised clinical trial , Eur Arch Paediatr Dent (2015) 16:13–18

Mohammed Nour Al-Halabi, Nada Bshara, Zuhair AlNerabieah Effectiveness of audio visual distraction using virtual reality eyeglasses versus tablet device in child behavioral management during inferior alveolar nerve block, ANAESTH, PAIN & INTENSIVE CARE; VOL 22(1) JAN-MAR 2018.

Patil VH, Vaid K, Gokhale NS, Shah P, Mundada M, Hugar SM. Evaluation of effectiveness of dental apps in management of child behaviour: A pilot study. Int J Pedod Rehabil 2017;2:14-8

9. Frankel SN, Shiere FR, Fogels HR. Should the parent remain in the operatory? ASDC J Dent Child 1962.;29:150–62

1 Harris RV, Lowers V, Van Der Zande M, Stanley M, Cooke R. Designing complex interventions: A description of the development of an intervention to reduce inequalities in planned dental visiting. Community Dent Oral Epidemiol. 2023 Feb 3. doi: 10.1111/cdoe.12842. Epub ahead of print. PMID: 36737879.

ANNEXURE-1

Modified YPAS Anxiety scale

The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parent). Each item has Likert-type response options reflecting behaviors. Children’s behavior is rated from 1 to 4 or 1 to 6 (depending on the item), with higher numbers indicating the highest severity within that item.

The score is calculated by dividing each item rating by the highest possible rating, adding all the produced values, dividing by 4, and multiplying by 100. This calculation produces a score ranging from 22.92 to 100, with higher values indicating greater anxiety. The mYPAS measure has strong internal reliability, interrater reliability, and convergent validity.

A.      Activity 1 = Looking around, curious, playing with toys, reading (or other age-appropriate behavior); moves around holding area/treatment room to get toys or go to parent; may move toward OR equipment.

 2  =  Not exploring or playing, may look down, may fidget with hands or suck thumb (blanket); may sit close to parent while waiting, or play has a definite manic quality. 

3  =  Moving from toy to parent in unfocused manner, nonactivity-derived movements; frenetic/frenzied movement or play; squirming, moving on table, may push mask away, or clinging to parent

 4  =  Actively trying to get away, pushes with feet and arms, may move whole body; in waiting room, running around unfocused, not looking at toys or will not separate from parent, desperate clinging

B.      Vocalizations 

1  = Reading (nonvocalizing appropriate to activity), asking questions, making comments, babbling, laughing, readily answers questions but may be generally quiet; child too young to talk in social situations or too engrossed in play to respond.

 2 = Responding to adults but whispers, “baby talk,” only head nodding.

 3 = Quiet, no sounds or responses to adults.

 4 = Whimpering, moaning, groaning, silently crying.

 5 = Crying or may be screaming “no.”

 6 = Crying, screaming loudly, sustained (audible through mask).

C.      Emotional expressivity

1 = Manifestly happy, smiling, or concentrating on play.

 2 = Neutral, no visible expression on face.

3 = Worried (sad) to frightened, sad, worried, or tearful eyes.

4 = Distressed, crying, extremely upset, may have wide eyes.

D.      State of apparent arousal

 1 = Alert, looks around occasionally, notices or watches what anesthesiologist does with him/her (could be relaxed).

2 =Withdrawn, child sitting still and quiet, may be sucking on thumb or face turned into adult.

3 =Vigilant, looking quickly all around, may startle to sounds, eyes wide, body tensed.

4 =Panicked whimpering, may be crying or pushing others away, turns away.

E.       Use of parents

1 =  Busy playing, sitting idle, or engaged in age appropriate behavior and does not need parent; may interact with parent if parent initiates the interaction.

2 = Reaches out to parent (approaches parent and speaks to otherwise silent parent), seeks and accepts comfort, may lean against parent.

 3 = Looks to parents quietly, apparently watches actions, does not seek contact or comfort, accepts it if offered or clings to parent.

 4 = Keeps parent at distance or may actively withdraw from parent, may push parent away or desperately clinging to parent and will not let parent go.