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Parental distress during paediatric dental treatment under nitrous oxide sedation and general anaesthesia: a prospective, comparative observational study

Parental distress during paediatric dental treatment under nitrous oxide sedation and general anaesthesia: a prospective, comparative observational study - ELBE-PZ

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00040651
Enrollment
100
Registered
2026-07-09
Start date
2026-05-18
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

Parental distress and anxiety in the context of paediatric dental treatment under pharmacological behaviour management

Interventions

Group 1: Nitrous oxide sedation (NOS): Parents of children receiving full-mouth rehabilitation under nitrous oxide sedation are approached at a prior planning appointment where possible, otherwise on
data collection begins on the treatment day. Data collection covers the entire rehabilitation trajectory (typically 3–4 sessions). Per session, data are collected on psychological (STAI), physiologica

Sponsors

Poliklinik für Kinderzahnheilkunde, Universitätsmedizin Greifswald
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Accompanying parent or legal guardian of a child aged 4 to 14 years scheduled for dental treatment under nitrous oxide sedation or general anaesthesia; capacity to provide written informed consent; sufficient German language proficiency to complete study questionnaires.

Exclusion criteria

Exclusion criteria: Known significant psychological disorder in the accompanying parent likely to substantially affect anxiety reporting; child with special health care needs (developmental, cognitive, or psychiatric) that substantially alter standard treatment or assessment; parent unwilling or unable to complete study questionnaires or procedures.

Design outcomes

Primary

MeasureTime frame
WHAT: Parental heart rate (HR) as an objective physiological indicator of distress and autonomic arousal, analysed as change from individual resting heart rate (delta-HR). WHEN: Continuously throughout the session, with primary focus on the anticipatory phase (waiting room to treatment onset) as the cross-modality comparable time window. HOW: Continuous recording using the O2Ring Wellue pulse oximeter; segmented according to the documented treatment timeline and analysed as change from individual resting heart rate (delta-HR).

Secondary

MeasureTime frame
Parental state anxiety assessed using the State-Trait Anxiety Inventory (STAI, short form). Collected on the day of treatment before the procedure (waiting room) and one week after treatment (post-measurement). Primary comparative measure: ?STAI (state relative to individual trait score). Exploratory measures: observer-rated parental behaviour (Parental Hetero-Assessment Scale, Vanhée et al. 2023) and child behaviour (Modified Venham Scale); the latter primarily in the NOS group, with potential application during the anaesthetic induction phase in the GA group.

Countries

Germany

Contacts

Public ContactOsama Oun Alsoud

Poliklinik für Kinderzahnheilkunde, Universitätsmedizin Greifswald

osama.ounalsoud@stud.uni-greifswald.de+49 3834 867136

Outcome results

None listed

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