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Effect of adding guided deep breathing to conventional behavior guidance on dental anxiety, pain, behavior, and heart rate in anxious children: a randomized controlled trial

Effect of adding guided deep breathing to conventional behavior guidance on dental anxiety, pain, behavior, and heart rate in anxious children: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82989047
Enrollment
64
Registered
2026-07-20
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Dental anxiety, pain, behavior, and heart rate in anxious children Oral Health

Interventions

Eligible children were randomly allocated to the control or intervention group in a 1:1 ratio using a computer-generated random sequence. 1. Control arm Children receive conventional behavior guidanc
Levi et al., 2022). It requires no device, application, or timer and is delivered through verbal instruction and live modelling alone, which keeps it applicable in resource-limited settings (Levi et a
the child places one hand on the abdomen to feel it rise and fall so that a diaphragmatic (belly-breathing) pattern is reinforced (Levi et al., 2022
Bahrololoomi et al., 2022). The exercise is demonstrated by the investigator, a dentist trained in guiding paediatric breathing exercises, and rehearsed with the child until it can be performed correc

Sponsors

Syrian Private University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1. Aged 5-8 years 2. Good general health (ASA physical status I) 3. Moderate-to-high dental anxiety (CFSS-DS total score = 32; range 15–75) 4. Requiring a dental procedure involving local anesthesia (pulpotomy of a primary molar) 5. Written parental/guardian consent and child assent

Exclusion criteria

Exclusion criteria: 1. Any systemic, neurological, developmental, or respiratory condition that could affect cooperation or breathing 2. A History of severe or disabling dental anxiety requiring pharmacological management 3. Refusal to participate by the parent or the child 4. Presence of any contraindication to local anesthesia or the specific anesthetic agent used

Design outcomes

Primary

MeasureTime frame
Dental Anxiety measured using Children’s Fear Survey Schedule–Dental Subscale (CFSS-DS; 15–75) at Before procedure, After breathing exercise, After anesthesia, End of session;Self-reported pain measured using Wong-Baker FACES Pain Rating Scale (ordinal, 0–10) at Before intervention, After breathing exercise, After anesthesia, End of session

Secondary

MeasureTime frame
Behavior measured using Frankl Behavior Rating Scale at during treatment;Heart rate measured using a portable, motion-tolerant, medical-grade pulse oximeter (Masimo Rad-G, Masimo SET® Measure-through Motion technology; Masimo Corporation, Irvine, CA, USA), which reports oxygen saturation, pulse rate and respiration rate from the photoplethysmogram (RRp) from a single fingertip pediatric sensor; parameters are logged automatically by the device’s internal data logger at Before procedure, After breathing exercise, After anesthesia, End of session

Countries

Syria

Contacts

Public ContactFehmieh Nawaya
dr.nawaya-f@hotmail.com; dr.fehmieh.nawaya@gmail.com+963 933506206

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026