The quality of spine surgery from the patient's perspective. Part 1: the Core Outcome Measures Index in clinical practice.
Anne F Mannion, F Porchet, F S Kleinstück...
https://pubmed.ncbi.nlm.nih.gov/19319578Actively Recruiting
Age: 14Years +
All Genders
ID06612853
Cross-cultural Adaptation Into German and Italian, Validation, Reproducibility, and Responsiveness of the Single-item Sleep Quality Scale in Spine Patients
Led by Schulthess Klinik · Updated on 2024-11-29
240
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Single-item Sleep Quality Scale (SQS), a simple tool for patients to self-assess sleep quality over a 7-day period, in people with spine disorders like low back pain. This study aims to translate and adapt the SQS into German and Italian and test its accuracy, reliability, and responsiveness in this patient group. Sleep is important for managing spine conditions, but has not been well studied in this population, so a validated, easy-to-use sleep questionnaire is needed. The study is conducted in two stages. First, the SQS will be translated and culturally adapted from English into German and Italian. Then, patients with spine disorders will complete the pre-final and final versions of the SQS along with the Pittsburgh Sleep Quality Index (PSQI) to assess validity and reproducibility. Patients will complete the SQS multiple times before treatment and again 3 months after either surgical or conservative treatment. This process will evaluate how well the SQS measures sleep quality and detects changes over time. Participants will fill in questionnaires at scheduled visits including before treatment and at 3 months follow-up. Researchers will monitor how clear and relevant the translations are, and compare SQS results with PSQI scores. They aim to confirm the SQS as a reliable, responsive tool for assessing sleep quality in spine patients. The study includes interviews to improve the translations and uses patient self-reporting without invasive procedures. Total participation duration varies but includes initial and follow-up assessments over several months.
CONDITIONS
Brief Title
Validation of the Single-item Sleep Quality Scale
Who Can Participate
Age: 14Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male and female patients
- German-speaking or Italian-speaking
- Diagnosis of spine pathology
- Age 14 years or older
- Cognitively intact (self-reported)
You will not qualify if you...
- Pregnancy (self-reported)
- Medical and/or pharmacological treatment for sleep disorders
- Melatonin intake
- Daily use of smart-watch or applications for automatic sleep detection
- Inability to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Pilot Testing
Duration - Up to 8 weeks from enrollment
Participants complete the pre-final version of the Single-item Sleep Quality Scale (SQS) once and provide feedback on linguistic clarity and relevance.
1 visit (in-person)
Field Testing
Duration - Approximately 3 months
Participants complete the final translated versions of the Single-item Sleep Quality Scale (SQS) and the Pittsburgh Sleep Quality Index (PSQI) twice before treatment, one week apart, to assess reproducibility, and a third time three months after treatment to assess responsiveness.
3 visits (in-person or remote): 2 visits before treatment one week apart, and 1 visit at 3 months after treatment
Trial Site Locations
Total: 1 location
1
Schulthess Klinik
Zurich, Canton of Zurich, Switzerland, 8008
Actively Recruiting
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Research Team
J
Jacopo Vitale, Dr. PhD
F
Fabio Galbusera, Eng PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Frequently Asked Questions
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Published Research Related To This Trial
Development of the "Core Yellow Flags Index" (CYFI) as a brief instrument for the assessment of key psychological factors in patients undergoing spine surgery.
Anne F Mannion, Francine Mariaux, Raluca Reitmeir...
https://pubmed.ncbi.nlm.nih.gov/32556625Sleep disorders: impact on daytime functioning and quality of life.
András Szentkirályi, Csilla Z Madarász, Márta Novák
https://pubmed.ncbi.nlm.nih.gov/19371179Practice parameters for the role of actigraphy in the study of sleep and circadian rhythms: an update for 2002.
Michael Littner, Clete A Kushida, W McDowell Anderson...
https://pubmed.ncbi.nlm.nih.gov/12749556Practice parameters for using polysomnography to evaluate insomnia: an update.
Michael Littner, Max Hirshkowitz, Milton Kramer...
https://pubmed.ncbi.nlm.nih.gov/14572131Measuring sleep quality.
Andrew D Krystal, Jack D Edinger
https://pubmed.ncbi.nlm.nih.gov/18929313Sleep evaluation scales and questionaries: a review.
H A Lomeli, I Pérez-Olmos, C Talero-Gutiérrez...
https://pubmed.ncbi.nlm.nih.gov/18286400The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research.
D J Buysse, C F Reynolds, T H Monk...
https://pubmed.ncbi.nlm.nih.gov/2748771A New Single-Item Sleep Quality Scale: Results of Psychometric Evaluation in Patients With Chronic Primary Insomnia and Depression.
Ellen Snyder, Bing Cai, Carla DeMuro...
https://pubmed.ncbi.nlm.nih.gov/30373688