WIP: Development of the Work In Progress Questionnaire

Sponsor
International Institute of Behavioral Medicines (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05932043
Collaborator
(none)
50
21

Study Details

Study Description

Brief Summary

The aim of this study is to describe the development of the Work In Progress questionnaire, a tool designed to evaluate commitment in persons, and its psychometric validation process in the context of low back pain.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: This is a non-interventional study

Detailed Description

The study design is cross-sectional.

The following methodology will be applied as for the development of the Work In Progress questionnaire (WIP), a tool designed to evaluate commitment in persons, and its psychometric validation:

  1. item generation and selection: the first defines the content of an index and ensures the most important topics are well-thought-out. The second eliminates redundant items, and decreases the number to a total that is feasible to administer while ensuring the scale measures the construct of interest.

  2. psychometric analysis: reliability (internal consistency by Cronbach's alpha, test-retest reliability by Intraclass Correlation Coefficient 2.1), Measurement error (calculated by multiplying the standard error of measurement (SEM) by the z-score associated with the desired level of confidence (95%, in our case) and the square root of 2), and construct validity by hypothesis testing the correlations (Pearson r) with related measures (Pain Catastrophizing Scale, Oswestry Disability Scale, Numerical pain Rating Scale).

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
What Can I do for my Low Back Pain? The Work In Progress Questionnaire!
Anticipated Study Start Date :
Jul 10, 2023
Anticipated Primary Completion Date :
Jul 10, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Outcome Measures

Primary Outcome Measures

  1. WIP questionnaire [At the moment of the questionnaire administration]

    Work In Progress questionnaire; score varying from 0 to 30, with higher scores indicating greater commitment

  2. WIP questionnaire [After 7-10 days later the first assessment (please, see above) as concerns test-retest assessment reliability.]

    Work In Progress questionnaire; score varying from 0 to 30, with higher scores indicating greater commitment

Secondary Outcome Measures

  1. PCS [At the moment of the questionnaire administration]

    Pain Catastrophizing Scale; score varying from 0 to 52, with higher scores indicating greater catastrophizing

  2. ODI [At the moment of the questionnaire administration]

    Oswestry Disability Index; score varying from 0 to 50, with higher scores indicating greater disability

  3. pain NRS [At the moment of the questionnaire administration]

    Numerical pain Rating Scale; score varying from 0 to 10, with higher scores indicating greater pain intensity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Low Back Pain

  • adult age

  • reading/speaking Italian.

Exclusion Criteria:
  • systemic illness, mental deficits, recent cerebrovascular accidents or myocardial infarctions, chronic lung or renal diseases;

  • refusal to adhere.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • International Institute of Behavioral Medicines

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barbara Rocca, Dr, International Institute of Behavioral Medicines
ClinicalTrials.gov Identifier:
NCT05932043
Other Study ID Numbers:
  • 2023-001
First Posted:
Jul 6, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Barbara Rocca, Dr, International Institute of Behavioral Medicines
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2023