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RECRUITING
NCT06612853

Validation of the Single-item Sleep Quality Scale

Sponsor: Schulthess Klinik

View on ClinicalTrials.gov

Summary

The single-item sleep quality scale (SQS) allows patients to provide a self-assessment of sleep quality over a 7-day recall period without significant additional burden. However, the SQS has not yet been utilized or validated in patients with spine pathologies. The main purpose of this study is to cross-culturally adapt the SQS from English to German and Italian and to test its validity in patients with back disorders. The study will be conducted in two stages. The first stage will involve the translation and cross-cultural adaptation of the SQS from English to German and Italian. The second stage will involve the evaluation of the instrument's face, content, and construct validity, reproducibility, and responsiveness in patients with back disorders.

Official title: Cross-cultural Adaptation Into German and Italian, Validation, Reproducibility, and Responsiveness of the Single-item Sleep Quality Scale in Spine Patients

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

OBSERVATIONAL

Enrollment

240

Start Date

2024-10-01

Completion Date

2025-12-31

Last Updated

2024-11-29

Healthy Volunteers

No

Conditions

Interventions

OTHER

Sleep Quality Scale (SQS)

For the pilot testing, each patient will complete the pre-final version of the SQS. The patients involved in the field study will have to fill in the SQS twice before treatment, one week apart, to assess reproducibility of the scale and a third time at 3 months after treatment (surgical or conservative) to assess the responsiveness of the scale.

OTHER

Pittsburgh Sleep Quality Index (PSQI)

The patients involved in the field test will have to fill in the PSQI twice before treatment, one week apart, to assess reproducibility of the scale and a third time at 3 months after treatment (surgical or conservative) to assess the responsiveness of the scale.

Locations (1)

Schulthess Klinik

Zurich, Canton of Zurich, Switzerland