Acceptability, feasibility, safety and efficacy of a perioperative hypnotherapeutic intervention in elderly patients undergoing cardiac surgery

Acceptability, feasibility, safety and efficacy of a perioperative hypnotherapeutic intervention in elderly patients undergoing cardiac surgery - HYPE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036452

Enrollment

Registered

2025-03-25

Start date

2024-12-01

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

I20-I25

Interventions

Group 1: Intervention group: Standardized perioperative hypnotherapeutic intervention with background music, applied via headphones (starting with induction of anesthesia, application throughout surge

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Cardiac surgery (bypass: off-pump coronary artery bypass [OPCAB Artery Bypass [OPCAB] and Coronary Artery Bypass on pump [CABG]; heart valve surgery: Aortic valve replacement on pump [AKE] and mitral valve replacement on pump [MKE]; combination procedure: AortoCoronary Bypass [ACB] + AKE) - Minimum age 65 years - Electively planned surgery - Sufficient hearing ability (without hearing aids) - Fluent in the German language

Exclusion criteria

Exclusion criteria: - Known existing dementia - Acute psychosis - Suicidal intentions - Alcohol and/or drug dependence - Inclusion in another clinical trial

Design outcomes

Primary

Measure	Time frame
The study is designed as a feasibility study, which will provide important information for the planning and implementation of a subsequent randomized controlled efficacy study. The primary aim of the feasibility study is to estimate important parameters that are required for the design of the main study: -Effects regarding the assessed outcomes to calculate the sample size for a subsequent study, -willingness of participants to be randomized, -willingness of clinicians to recruit participants, -the number of eligible patients, -variance of the proposed outcomes, -follow-up and response rates.	—

Measure

Time frame

The study is designed as a feasibility study, which will provide important information for the planning and implementation of a subsequent randomized controlled efficacy study. The primary aim of the feasibility study is to estimate important parameters that are required for the design of the main study: -Effects regarding the assessed outcomes to calculate the sample size for a subsequent study, -willingness of participants to be randomized, -willingness of clinicians to recruit participants, -the number of eligible patients, -variance of the proposed outcomes, -follow-up and response rates.

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Secondary

Measure	Time frame
Secondary objectives: -Testing the feasibility of the study-related measures -Testing the safety of the hypnotherapeutic intervention -Final specification of the primary and secondary outcomes for the subsequent efficacy study. In a broader approach, various endpoints are therefore recorded: Anxiety, pain, well-being, frequency and severity of postoperative delirium, as well as the frequency and severity of neurocognitive disorders and disease-related impaiments at follow-up.	—

Measure

Time frame

Secondary objectives: -Testing the feasibility of the study-related measures -Testing the safety of the hypnotherapeutic intervention -Final specification of the primary and secondary outcomes for the subsequent efficacy study. In a broader approach, various endpoints are therefore recorded: Anxiety, pain, well-being, frequency and severity of postoperative delirium, as well as the frequency and severity of neurocognitive disorders and disease-related impaiments at follow-up.

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Countries

Germany

Contacts

Public ContactJenny Rosendahl

Institut für Psychosoziale Medizin, Psychotherapie und Psychoonkologie Jena

jenny.rosendahl@med.uni-jena.de+49 3641 9398038

Outcome results

None listed

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