RecruitingNCT06612853

Validation of the Single-item Sleep Quality Scale

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

Sponsor

Schulthess Klinik

Enrollment

240 participants

Start Date

Oct 1, 2024

Study Type

OBSERVATIONAL

Conditions

Spine Disorder

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.

Eligibility

Min Age: 14 Years

Inclusion Criteria5

both male and female patients
German-speaking or Italian-speaking
diagnosis of spine pathology
age ≥ 14 years
cognitively intact (self-reported)

Exclusion Criteria5

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

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Interventions

OTHERSleep 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.

OTHERPittsburgh 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

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NCT06612853