Influence of the mother's voice on sedation needs and stress factors during pediatric cardiological examinations in the heart catheter

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023774

Enrollment

Registered

2020-12-14

Start date

2021-04-19

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Q24

Interventions

Group 1: Sedation with fairy tales In this group, the mother is asked to read a 15-minute fairy tale, this is recorded using the study team's tablet. During the cardiac catheterization, this fairy tal

Eligibility

Sex/Gender

All

Age

0 Years to 3 Years

Inclusion criteria

Inclusion criteria: Heart catheter examination under sedation Willingness to record the voice Declaration of consent of the legal parents or guardians

Exclusion criteria

Exclusion criteria: No existing declaration of consent of the legal parents or guardians Lack of German language competence ASA 4 or larger Emergency interventions Intensive care or ventilated patients

Design outcomes

Primary

Measure	Time frame
Evidence of a sedative and stress-reducing effect of the mother's voice in children receiving cardiac catheterization under sedation Sedation for cardiac catheterization is performed according to hospital standards. The anesthesia protocols can be used to evaluate whether the children in the "with fairy tales" group may have needed less medication for sedation. The non-invasive pain monitor records an index during sedation, which can be evaluated with regard to pain levels during defined events. These include, for example, the placement of a venous access or the inguinal puncture. Stress hormones are determined from saliva. The time points for the child are (depending on the group): arrival in the operating room, 30 minutes after the start of voice, 60 minutes after the start of voice, end of cardiac catheterization, arrival in the recovery room, immediately after awakening, 30 minutes after awakening, 45 minutes after awakening.	—

Measure

Time frame

Evidence of a sedative and stress-reducing effect of the mother's voice in children receiving cardiac catheterization under sedation Sedation for cardiac catheterization is performed according to hospital standards. The anesthesia protocols can be used to evaluate whether the children in the "with fairy tales" group may have needed less medication for sedation. The non-invasive pain monitor records an index during sedation, which can be evaluated with regard to pain levels during defined events. These include, for example, the placement of a venous access or the inguinal puncture. Stress hormones are determined from saliva. The time points for the child are (depending on the group): arrival in the operating room, 30 minutes after the start of voice, 60 minutes after the start of voice, end of cardiac catheterization, arrival in the recovery room, immediately after awakening, 30 minutes after awakening, 45 minutes after awakening.

—

Secondary

Measure	Time frame
Reduction in Emergence Delir	—

Countries

Germany

Contacts

Public ContactEhrenfried Schindler

Sektionsleiter Kinderanästhesie, Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Bonn

ehrenfried.schindler@ukbonn.de0228 37594

Outcome results

None listed

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