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Positive Cueing in Knee Arthroplasty.

NCT05703087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-01-27

No results posted yet for this study

Summary

To the knowledge of the investigators, the feasibility of an RCT assessing the use of positive cueing in an information video for patients undergoing primary TKA is currently unclear.

The investigators conducted a feasibility study with the primary objective to assess the acceptability of the randomized controlled trial (RCT) procedure for participating patients. The secondary objective was to evaluate the rate of recruitment, the comprehensibility (do patients understand what is expected of them during the trial) and if there were any adjustments necessary to the design of the study. The outcome of the current feasibility study will be used to determine whether adjustments are required to the design of the RCT before we proceed.

Conditions

  • Osteoarthritis, Knee
  • Psychological Stress
  • Mental Stress

Interventions

BEHAVIORAL

Positive cueing in the information video before a primary TKA

Two weeks before the surgery, in the outpatient clinic (during their preoperative appointment), the pre-surgery information video was shown to the patients. Patients were randomly allocated to either the positive cueing group (intervention) or the standard care group (control) with Castor EDC (14) using a variable block randomization model. Patients did not know whether they watched the adapted video or the standard video.

Sponsors & Collaborators

  • Onze Lieve Vrouwe Gasthuis

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2021-11-01
Completion
2021-11-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05703087 on ClinicalTrials.gov