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NCT04274530 · ClinicalTrials.gov registry record · NA

Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial

A NA study, sponsored by McMaster University.

Completed
Registry status
NA
Development phase
1,024
Enrollment target

NCT04274530: Completed NA study, sponsored by McMaster University.

NCT04274530 is a NA study that has completed, run by McMaster University. The registered enrollment target is 1,024 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04274530, a NA study, has completed, sponsored by McMaster University.

COMPLETED
Registry status
NA
Development phase
1,024 participants
Enrollment target

Study Summary

Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. To study this relationship, patients will undergo cognitive behavioural therapy (CBT) which is designed to modify such thoughts with the goal of reducing ongoing pain and improving quality of life. The goal of this study is to determine if CBT, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain (PPSP) over 12-months post-fracture in patients with an open or closed fracture of the appendicular skeleton, treated with internal fixation.

Primary Outcome

The primary outcome is PPSP according to the World Health Organization's (WHO) proposed definition. The WHO's definition requires 4 criteria for the diagnosis of PPSP: 1) Pain that began after surgery or a tissue trauma is experienced; 2) The pain is in an area of preceding surgery or tissue trauma, 3) The pain persisted for at least three months after the initiating event, and 4) The pain is not better explained by an infection, a malignancy, a pre-existing pain condition or any other alternat

Interventions

  • BEHAVIORAL Cognitive Behavioural Therapy

Trial Details

FieldValue
Enrollment Target 1,024 participants
Start Date 2021-01-25
Est. Completion 2025-08-18
Phase NA
McMaster University

31 total trials

What the finished NCT04274530 record still lists

NCT04274530 is an interventional study that assigns participants to a tested intervention. Its 1,024 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (27% lower).

The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioural Therapy is the first listed.

NCT04274530 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04274530 about?

NCT04274530 is a clinical study titled "Cognitive Behavioural Therapy to Optimize Post-Operative Recovery Trial". Psychological factors such as stress, distress, anxiety, depression, and poor coping strategies may be associated with ongoing pain following injuries such as fractures. To study this relationship, patients will undergo cognitive behavioural therapy (CBT) which is designed to modify such thoughts wi...

What is the current status of trial NCT04274530?

This trial is currently completed. It is a NA study. The enrollment target is 1,024 participants. The study started on 2021-01-25. Estimated completion is 2025-08-18.

What interventions are being tested in trial NCT04274530?

The interventions under investigation include: Cognitive Behavioural Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT04274530?

This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04274530's enrollment target sits among peer trials

1,024 105th of 2000 higher than 1,895 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04274530, the US trial registry maintained by the National Library of Medicine. NCT04274530 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.