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Comparison of preoperative information media and their influence on the anxiety level of 4 to 11 year old children and their caregivers

Comparison of preoperative information media and their influence on the anxiety level of 4 to 11 year old children and their caregivers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032891
Enrollment
300
Registered
2023-10-18
Start date
2023-10-23
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Anxiety level (State and trait anxiety)

Interventions

Group 1: guided tour Group 2: film Group 3: book Group 4: audiobook Group 5: control group

Sponsors

Universitäsklinikum Ulm, Sektion Kinderchirurgie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 10 Years

Inclusion criteria

Inclusion criteria: Uncomplicated planned operation, understanding of the German language

Exclusion criteria

Exclusion criteria: Pre-existing conditions with more than 2 inpatient hospitalisations in the past, serious complications during surgery. Pre-diagnosed anxiety disorders

Design outcomes

Primary

MeasureTime frame
Anxiety level of children and caregivers before surgery at time T2 compared to the control group. Trait anxiety of all study participants will be collected once. State anxiety will be collected at four time points. At T0, state and trait anxiety will be recorded after consent to the study. At T1, state anxiety will be recorded after the interventions have been performed. T2 is in the hospital on the day of the operation before the surgery; state anxiety is also recorded here. Finally, state anxiety is recorded before release from the hospital, after surgery at T3. The anxiety level of the adults is assessed using the Grimm: State Anxiety Questionnaire short and Grimm: Trait Anxiety Questionnaire short. The children's trait anxiety will be assessed using the Hospital fear rating scale (Melamed, Siegel 1975) translated into German. The children's state anxiety is determined by the visualised Koala scale (based on the childrens fear scale (McMurtry et al. 2011), visualised as a Koala scale (Muris et al. 2003)).

Secondary

MeasureTime frame
Changes in anxiety levels of children and caregivers during hospitalisation over time T0-T3. Correlations of anxiety levels of caregivers and their children.

Countries

Germany

Contacts

Public ContactAlexandre Serra

Universitätsklinikum Ulm, Sektion Kinderchirurgie

alexandre.serra@uniklinik-ulm.de0049 731 500-53701

Outcome results

None listed

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