Does audiovisual distraction reduce the need for analgesic sedation and increase patient satisfaction in patients undergoing mitral valve clipping? — A randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037370

Enrollment

Registered

2025-07-15

Start date

2023-02-23

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

I34.0

Interventions

Group 1: Deactivated video goggles during transcatheter mitral valve repair Group 2: Activated video goggles displaying a nature documentary during transcatheter mitral valve repair

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing catheter-based mitral valve repair

Exclusion criteria

Exclusion criteria: Patients without informed consent Patients aged = 18 years Pre-existing conditions: deafness, epilepsy

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the average dosage of propofol (in mg/kg/h) required for sedation during the procedure. Data collection occurs intraoperatively, from the initiation of sedation until the removal of the transesophageal echocardiography (TEE) probe at the end of the mitral transcatheter edge-to-edge repair procedure. Propofol dosage is recorded in the standardized anesthesia protocol, capturing both bolus administrations and continuous infusion rates. The total administered dose is normalized to body weight and procedural time to calculate an average rate (mg/kg/h), enabling standardized comparison across patients.	—

Measure

Time frame

The primary endpoint of the study is the average dosage of propofol (in mg/kg/h) required for sedation during the procedure. Data collection occurs intraoperatively, from the initiation of sedation until the removal of the transesophageal echocardiography (TEE) probe at the end of the mitral transcatheter edge-to-edge repair procedure. Propofol dosage is recorded in the standardized anesthesia protocol, capturing both bolus administrations and continuous infusion rates. The total administered dose is normalized to body weight and procedural time to calculate an average rate (mg/kg/h), enabling standardized comparison across patients.

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Secondary

Measure	Time frame
Reduction of Anxiety, Stress, and Pain Time of Assessment: These parameters are assessed pre- and post-procedurally, on the day of the intervention, with follow-up immediately after the procedure once the patient is fully awake and responsive. Method of Measurement: Anxiety and Pain are measured using the Numerical Rating Scale (NRS) from 0 (no anxiety/pain) to 10 (worst imaginable anxiety/pain). Subjective stress reduction is inferred from changes in anxiety and pain levels and supplemented by patient-reported comfort levels (scale 0–3) immediately after the procedure. Additionally, overall satisfaction is assessed using the ZUF-8 questionnaire two days after the procedure, which reflects perceived care quality, comfort, and subjective well-being during hospitalization. Changes between pre- and post-procedural values are compared between the intervention and control group to assess the efficacy of audiovisual distraction.	—

Measure

Time frame

Reduction of Anxiety, Stress, and Pain Time of Assessment: These parameters are assessed pre- and post-procedurally, on the day of the intervention, with follow-up immediately after the procedure once the patient is fully awake and responsive. Method of Measurement: Anxiety and Pain are measured using the Numerical Rating Scale (NRS) from 0 (no anxiety/pain) to 10 (worst imaginable anxiety/pain). Subjective stress reduction is inferred from changes in anxiety and pain levels and supplemented by patient-reported comfort levels (scale 0–3) immediately after the procedure. Additionally, overall satisfaction is assessed using the ZUF-8 questionnaire two days after the procedure, which reflects perceived care quality, comfort, and subjective well-being during hospitalization. Changes between pre- and post-procedural values are compared between the intervention and control group to assess the efficacy of audiovisual distraction.

—

Countries

Germany

Contacts

Public ContactTobias Schmidt

Medizinische Klinik II, Universitätsklinikum Schleswig-Holstein, Campus Lübeck

to.schmidt@asklepios.com?+49 151 17485817?

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 23, 2026