Evaluating the Effect of Anesthetic Injection Technique on Behavioral Pain Responses

"Evaluating Behavioral Pain Responses During Local Anesthesia Injection Using the Novel 'Cap on Head' Technique Compared to the Conventional Method in Children Aged 3 to 7 Years"

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250416065353N1

Enrollment

Registered

2025-05-02

Start date

2025-04-30

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Evaluating Behavioral Pain Responses During Local Anesthetic Injection Using the Novel 'Cap on Head' Method Compared to Conventional Injection in Children Aged 3-7 Years.

Interventions

Intervention 1: Control group: In the conventional anesthesia method, a small amount of topical anesthetic gel (approximately the size of a swab tip) was applied using a cotton-tipped applicator for 1

Eligibility

Sex/Gender

All

Age

3 Years to 7 Years

Inclusion criteria

Inclusion criteria: All healthy children aged 3 to 7 years without history of systemic or psychological disorders with no previous history of local anesthesia administration and whose parents/guardians provided informed consent for participation

Exclusion criteria

Exclusion criteria: Children under 3 years or over 7 years of age Children with systemic or psychological disorders Children with a history of local anesthesia administration Children whose parents/guardians declined to provide consent

Design outcomes

Primary

Measure	Time frame
Pain-related behavioral responses. Timepoint: Directly after local anesthetic injection. Method of measurement: Children's pain responses will be evaluated using the Face, Head, Feet, Hands, Trunk, and Cry (FHFHTC) scale, originally developed by Bagherian et al. This instrument was adapted from the validated FLACC (Face, Legs, Activity, Cry, Consolability) scale for postoperative pain assessment in young children. Scoring System :Each item is scored 0-3Total possible score range: 0-18Higher scores indicate more severe injection-related distress Assessment Protocol :Two additional nurses blinded to the study hypothesis will independently document responses : Nurse 1: Observes and records facial expressions, head movements, and crying Nurse 2: Records hand, foot, and trunk movements Psychometric Properties :The scale's reliability and validity have been previously established by Bagherian and colleagues in their original validation study.	—

Measure

Time frame

Pain-related behavioral responses. Timepoint: Directly after local anesthetic injection. Method of measurement: Children's pain responses will be evaluated using the Face, Head, Feet, Hands, Trunk, and Cry (FHFHTC) scale, originally developed by Bagherian et al. This instrument was adapted from the validated FLACC (Face, Legs, Activity, Cry, Consolability) scale for postoperative pain assessment in young children. Scoring System :Each item is scored 0-3Total possible score range: 0-18Higher scores indicate more severe injection-related distress Assessment Protocol :Two additional nurses blinded to the study hypothesis will independently document responses : Nurse 1: Observes and records facial expressions, head movements, and crying Nurse 2: Records hand, foot, and trunk movements Psychometric Properties :The scale's reliability and validity have been previously established by Bagherian and colleagues in their original validation study.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactKamyab Keivanloo

Birjand University of Medical Sciences

Kamyabk1loo@gmail.com+98 51 3871 1565

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026