The effect of consent material on participants’ willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study

Not Applicable

• Conditions: Shoulder pain; Arthroscopic subacromial decompression surgery; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12620001132932
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-30
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients will be considered for inclusion if they are aged 18 years or older; have consented for arthroscopic subacromial decompression (ASD) with one of the orthopaedic surgeons from St Vincent's Hospital Melbourne (SVHM) or have consented to surgery at the private rooms of a surgeon who conducts surgery at SVHM; have a mastery of the English language.

Exclusion Criteria

i) Patients undergoing revision surgery ii) Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia) iii) Unable to provide informed consent without the aid of an interpreter.

Study & Design

• Study Type: Interventional
• Study Design: Not specified