Need for the study

Managing a fearful, anxious, uncooperative child is one of the most challenging aspect a

pediatric dentist faces in day-to-day practice.

Various behaviour guidance techniques are used to manage such patients to provide proper

treatment.

The Papoose board, a passive restraint is one of the protective stabilizing aid used to stabilize the

patient decreasing risk of injury while allowing safe completion of treatment.

The use of the restraint is a cost-effective, non-pharmacological modality than using

pharmacological methods like sedation or general anesthesia.

The literature reports that patients & parents have negative experiences with the conventional

papoose board.

Changes need to be made in the conventional design to increase child compliance.

Hence, the present study will be conducted to compare and evaluate the attitude and perception

of parents for the use of Papoose board and Comfy wrap physical restrainer as a behaviour

guidance technique in pediatric patients during dental procedure.

Review of Literature

Robert I. Frankel (1991) conducted a survey to determine mothers’ attitudes towards the use of

a Papoose Board. 74 mothers were surveyed using a questionnaire. The study concluded that

mothers had positive attitude towards the use of Papoose board.

P. Malik et al (2021) aimed to understand how parents or caregivers experienced physical

constraint and the use of the papoose board on their children during regular dental treatment. Indepth

individual interviews with a purposive sample of 7 parents or caregivers were conducted.

The study concluded that using a papoose board should remain an extraordinary measure and,

more generally, that dental professionals should reflect on the place of children and their families

in clinical encounters.

Hsin-Yung Chen et al (2021) conducted a crossover study intervention trial to investigate the

behavioral and physiological effects of deep touch pressure for participants receiving dental

treatment. Nineteen disabled participants were assessed. This study provides not only

physiologic evidence for the modulation effects of deep touch pressure on stressful conditions

but also the application of papoose board, as a sensory adaptation technique, is not harmful for

dental patients with special needs.

Norsaima Ismail et al (2022) aimed to investigate the physiological variations of children with

special health care needs while using a Papoose board and a combination of basic behaviour

guidance during dental treatment. This is a randomised crossover trial involving 90 children.

Exposure A is a combination of tell-show-do, distraction, and positive reinforcement, while

exposure B is passive immobilisation with a Papoose board. The measurement of children’s

blood pressure, heart rate, and oxygen saturation level with the application of a Papoose board or

3

a combination of the basic behaviour guidance revealed no significant changes. The study

concluded that the use of a Papoose board is safe and has no discernible influence on the child’s

physiological responses.

 Aim of the study:

To compare and evaluate the attitude and perception of parents for the use of Papoose board and

Comfy wrap physical restraint as a behaviour guidance technique in pediatric patients during

dental procedure in a cross over study design.

Objectives of the study:

1) To evaluate the attitude and perception of parents for the use of Papoose board as a physical

restraint during dental treatment in pediatric patients.

2) To evaluate the attitude and perception of parents for the use of Comfy-wrap as a physical

restraint during dental treatment in pediatric patients.

3) To evaluate and compare the attitude and perception of parents for the use of Papoose board

and Comfy-wrap as a physical restraint during dental treatment in pediatric patients.

Materials and Methods

Source of data.

Type of study

A Cross-over study

In-vitro/in-vivo/survey

In – vivo study

Source from where the cases, patients, subjects or study material will be selected

Patients reporting to the Department of Pediatric and Preventive Dentistry in

Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune.

Name and place where the study will be conducted

Department of Pediatric and Preventive Dentistry in Dr. D. Y. Patil Dental College and

Hospital, Pimpri, Pune.

Method of data collection

Sampling technique used –

Random sampling technique

Sample size: n= 40

Size of each group or sub-group, age, gender distribution:

20 children in each group of 4-7 years age

Group A: 1- Papoose board in 1st intervention.

2- Comfy-wrap in 2nd intervention.

Group B: 1- Comfy-wrap 1st intervention.

2- Papoose board in 2nd intervention.

Inclusion criteria

Patients with age group 4-7 years of age.

Patients with Frankl’s behaviour rating scale 1 & 2.

Patient requiring local anesthesia for dental treatment for two or more procedures.

 Patients with informed parental consent.

Exclusion criteria

Patient with history of allergy or asthma.

 Patient with special health care needs.

Patient with any debilitating disease.

Patients with Frankl’s behaviour rating scale 3 & 4.

Patient who is a known allergic to local anesthetic agent.

For clinical studies, it is important to state that prior to starting the research work, written

informed consent will be taken from the respective authorities, hospitals, patients/subjects,

parents/caretakers.

Prior to starting the research work, permission to conduct the study will be obtained from

the Scientific and Ethical committee of the Dr. D. Y. Patil Dental College and Hospital.

A written informed consent will be duly obtained from the parents prior to the conduction

of the study

Enlist the materials / instruments/armamentarium to be used in the study

Papoose board

Comfy-wrap

Lignocaine with adrenaline in syringe with 27-gauge needle.

Smart watch

Describe how the study will be done in a step-wise chronological sequence.

Patient will be selected according to the Inclusion criteria & Exclusion criteria

The procedure will be explained to each participant’s parent & informed consent will be

obtained

Patients will be divided randomly into two groups i.e. Group A & Group B & intervention

will be done in the next visit.

Group A

First Papoose board will be

used as a physical restraint &

local anesthesia will be

administered by the operator

for the required procedure

After the procedure, evaluation

of the attitude and perception

of parents for the use of

Papoose board as a physical

restraint will be done through a

questionnaire filled by parents

Washout period of 7 days

In the next visit, Comfy-wrap

will be used as a physical

restraint & same local

anesthestic procedure will be

carried out by the same

operator for the required

procedure

After the procedure, evaluation

of the attitude and perception

of parents for the use of

Comfy-wrap as a physical

restraint will be done through a

questionnaire filled by parents

8.3 Duration of study: 12 months

Group B

First Comfy wrap will be used

as a physical restraint & local

anesthesia will be administered

by the operator for the required

procedure

After the procedure, evaluation

of the attitude and perception

of parents for the use of Comfy

wrap as a physical restraint will

be done through a

questionnaire filled by parents

Washout period of 7 days

In the next visit, Papoose board

will be used as a physical

restraint & same local

anesthestic procedure will be

carried out by the same

operator for the required

procedure

After the procedure, evaluation

of the attitude and perception

of parents for the use of

Papoose board as a physical

restraint will be done through a

questionnaire filled by parents

Assessment of vital parameters will be done in both the groups

Data will be recorded from Group A & Group B and tabulated

Results will be analyzed using statistical analysis method

Method of data analysis.

Descriptive & Inferential statistics

 Does the study require any investigation or intervention to be made on patients, any

human or animals?

Yes

If Yes, briefly describe.

Local anesthesia will be administered using Papoose board /Comfy-wrap as a physical restraint

& evaluation of attitude & perception of parents will be done through a questionnaire.

 List of References

1) Frankel RI. The Papoose Board and mothers’ attitudes following its use. Pediatr dent. 1991

Sep 1;13(5):284-8.

2) American Academy of Pediatric Dentistry. Use of pro- tective stabilization for pediatric

dental patients. The Reference Manual of Pediatric Dentistry. Chicago, Ill.: American

Academy of Pediatric Dentistry; 2022:340-6.

3) Malik P, Ferraz Dos Santos B, Girard F, Hovey R, Bedos C. Physical constraint in pediatric

dentistry: the lived experience of parents. JDR Clinical & Translational Research. 2022

Oct;7(4):371-8.

4) Chen HY, Yang H, Chi HJ, Chen HM. Physiologic and behavioral effects of papoose board

on anxiety in dental patients with special needs. Journal of the Formosan Medical

Association. 2014 Feb 1;113(2):94-101.

5) Mokhtar IW, Suhaimi AS, Ahmad MS, Baharuddin IH, Andytan NI. The Papoose Board:

Parents’ Perceptions and Attitudes of Its Usage in Their Child’s Dental Treatment. Journal of

Dentistry Indonesia. 2019;26(3):133-9.

6) Al-Jobair AM, Al-Mutairi MA. Saudi dental students’ perceptions of pediatric behavior

guidance techniques. BMC Medical Education. 2015 Dec;15(1):1-9.

7) Ismail N, Isa KA, Wan Mokhtar I. A Randomised Crossover Trial of Behaviour Guidance

Techniques on Children with Special Health Care Needs during Dental Treatment: The

Physiological Variations. Children. 2022 Oct 5;9(10):1526

8) Al-Jobair AM, Al-Mutairi MA. Saudi dental students’ perceptions of pediatric behavior

guidance techniques. BMC Medical Education. 2015 Dec;15(1):1-9

9) Guinot F, Virolés M, Lluch C, Costa AL, Veloso A. Spanish and portuguese parental

acceptance of behavior management techniques in pediatric dentistry. Journal of Clinical

Pediatric Dentistry. 2021;45(4):247-52.

10) Zhou F, Zhang S, Ma W, Xiao Y, Wang D, Zeng S, Xia B. The long-term effect of dental

treatment under general anaesthesia or physical restraints on children’s dental anxiety and

behaviour. European Journal of Paediatric Dentistry. 2022 Mar 1;23(1):27-32.

11) Weaver JM. Why is physical restraint still acceptable for dentistry?. Anesthesia progress.

2010;57(2):43-4.