Effectiveness of a dental simulation game on children behavior during pulp treatments in primary molars: a randomized controlled trial

Effectiveness of a dental simulation game on children behavior during pulp treatments in primary molars

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30470866

Enrollment

Registered

2024-04-19

Start date

2024-02-09

Completion date

Unknown

Last updated

2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and anxiety during primary molars pulpotomy in pediatric patients aged 6-10 years. Oral Health

Interventions

This study was designed as a triple-blinded, two-arm, parallel-group randomized active-controlled trial. 60 patients were recruited and randomly divided into two groups: Group 1: control group, TSD te

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 6-10 years. 2. Children could be categorized as definitely positive or positive ratings, according to Frankel's behavior rating scale. 3. Children required pulpotomy for a primary molar. 4. Children were familiar with smartphone games.

Exclusion criteria

Exclusion criteria: 1. Children with oral, mental, and/or systemic conditions. 2. Children could be categorized as definitely negative or negative ratings, according to Frankel's behavior rating scale. 3. Children with previous dental surgery experience and/or traumatic dental experience.

Design outcomes

Primary

Measure	Time frame
1.Pulse rate The pulse rate was measured using a finger pulse oximeter (Alpha, Prolinx GmbH, Düsseldorf, Germany) at four time points: (1) at the baseline in the waiting room (t0). (2) After conditioning the child before initiating the treatment (t1). (3) Mean pulse rate during treatment (t2). (4) After completing the final restoration and finishing the treatment (t3). Pulse rate is an objective measurement of dental anxiety. 2.RMS Pictorial Scale. RMS pictorial scale was recorded at four time points: (1) at the baseline in the waiting room (t0). (2) After conditioning the child before initiating the treatment (t1). (3) Immediately after amputating of the pulp (t2). (4) After completing the final restoration and finishing the treatment (t3). RMS pictorial scale is a subjective measurement of dental anxiety. 3.Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale FLACC behavioral pain scale was recorded during treatment (t2). FLACC behavioral pain assessment scale is a non-verbal, self-report pain scale.	—

Measure

Time frame

1.Pulse rate The pulse rate was measured using a finger pulse oximeter (Alpha, Prolinx GmbH, Düsseldorf, Germany) at four time points: (1) at the baseline in the waiting room (t0). (2) After conditioning the child before initiating the treatment (t1). (3) Mean pulse rate during treatment (t2). (4) After completing the final restoration and finishing the treatment (t3). Pulse rate is an objective measurement of dental anxiety. 2.RMS Pictorial Scale. RMS pictorial scale was recorded at four time points: (1) at the baseline in the waiting room (t0). (2) After conditioning the child before initiating the treatment (t1). (3) Immediately after amputating of the pulp (t2). (4) After completing the final restoration and finishing the treatment (t3). RMS pictorial scale is a subjective measurement of dental anxiety. 3.Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale FLACC behavioral pain scale was recorded during treatment (t2). FLACC behavioral pain assessment scale is a non-verbal, self-report pain scale.

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Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Syria

Contacts

Public ContactMawia Karkoutly

mawia95.karkoutly@damascusuniversity.edu.sy+963 992 647 528

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026