Validation of the Single-item Sleep Quality Scale
ConditionSpine Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorSchulthess Klinik
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
both male and female patients
German-speaking or Italian-speaking
diagnosis of spine pathology
age ≥ 14 years
Disqualifiers
pregnancy (self-reported)
medical and/or pharmacological treatment for sleep disorders
melatonin intake
daily use of smart-watch or applications for automatic sleep detection
Trial population
Patients with spinal disorders, being considered for spinal surgery or conservative treatment, and with a good understanding of the German or Italian language will be recruited at the Schulthess Clinic. For the pilot testing, patients will be recruited immediately after their outpatient examination. For the field testing, patients waiting for surgery or conservative treatment will be recruited. A total of 20 patients, complying with the inclusion and exclusion criteria listed above, will be involved in the pilot test and a total of 100 patients will be involved in the field test. Therefore, n=120 patients will be recruited for each language translation, with a total of n=240 patients.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sleep Quality Scale (SQS)
Other interventionFor 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.
Pittsburgh Sleep Quality Index (PSQI)
Other interventionThe 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Pilot testing1 intervention
Group B: Field testing2 interventions
Trial outcomes
Primary outcomes
1
Translation and cross-cultural adaptation of the Single-item Sleep Quality Scale (SQS) in Italian and German
Outcome: translated version of the SQS in Italian and German
Time frame
Within 8 weeks following the enrollment of the translators and expert commitee for the translation process.2
Field-testing of the Single-item Sleep Quality Scale (SQS) final translated version for responsiveness
SQS responsiveness. A ROC curve analysis will be used to explore the ability of the SQS change scores to differentiate between patients who have and have not improved (dichotomized), according to the Pittsburgh Sleep Quality Index (PSQI) delta scores of Item 6 (sleep quality). Using the ROC curve, the responsiveness will be described in terms of sensitivity and specificity. We will consider an AUC of at least 0.70 to be adequate. The optimal cut off point will be computed using the Youden index.
Time frame
At 3 months (week 12) after treatment (surgical or conservative)3
Field-testing of the Single-item Sleep Quality Scale (SQS) final translated version for construct validity
SQS construct validity. Outcome: the construct validity will be calculated through Spearman\'s correlation coefficient between SQS score (from 0 to 10) and the questionnaire item 6 (sleep quality) of the Pittsburgh Sleep Quality Index (PSQI). The strength of the relationship will be described as excellent (0.81-1.0), very good (0.61-0.80), good (0.41-0.60), fair (0.21-0.40), and poor (0.20-0.0).
Time frame
At week 1, before treatment.4
Pilot-testing of the Single-item Sleep Quality Scale (SQS) pre-final translated version for content validity
SQS content validity Outcome: the content validity ratio (CVR). CVR will be calculated as follows: CVR= \[ne - (N/2)\] / (N/2), where ne is the number of experts indicating an item "essential," and N is the total number of experts. Therefore, considering the sample size (n=20) for pilot testing and the recognized Lawshe\'s CVR critical values, a CVR value of 0.50 is expected (corresponding to a 75% of agreement).
Time frame
Within 8 weeks from the enrollment of the patients. Patients will be recruited immediately after their outpatient examination and they will fill in the SQS once.Sponsors and contacts
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Source ClinicalTrials.gov