IHEART trial: study protocol for a German multicentre randomised controlled trial on the feasibility and acceptance of an internet-based preoperative intervention to optimise patient expectations and improve outcomes after heart surgery.

ABSTRACT:

Introduction

Treatment expectations are a key mechanism of placebo effects in clinical trials. In a previous study (PSY-HEART-I), preoperative expectation optimisation improved quality of life 6 months postcardiac surgery. However, barriers such as travel distance, staffing shortages and COVID-19 limited participation. This study evaluates the feasibility and acceptability of iEXPECT, a brief internet-based intervention designed to optimise expectations before heart surgery.

Methods and analysis

In this three-arm, multicentre randomised controlled trial, 160 patients undergoing elective coronary artery bypass graft surgery are randomised to: (a) standard of care (SOC); (b) SOC plus iEXPECT with phone-based guidance (iEXPECT enhanced) or (c) SOC plus iEXPECT with email-based

SUBMITTER: Compere VN 

PROVIDER: S-EPMC12458749 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature