Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000574246
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
16/04/2018
Date last updated
16/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of Sleep and Life Qualities of Individuals with Low Back Pain;
Single-Centered, Prospective Observational Study
Scientific title
Assessment and measurement of Sleep and Life Qualities of Individuals with Low Back Pain by PSQI and RMDQ;Single-Centered, Prospective Observational Study
Secondary ID [1] 293767 0
none
Universal Trial Number (UTN)
U1111-1207-5601
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 306168 0
Impairment of Life Qualities 306605 0
Impairment of Sleep 306606 0
Condition category
Condition code
Anaesthesiology 305279 305279 0 0
Pain management
Neurological 305280 305280 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Fifty adult patients aged between 18 and 65 were included in the study. Questionnaires were distributed to the patients in polyclinic of the pain and according to the results of these questionnaires, patients were divided into two groups with good sleep quality (group 1: PSQI 5 and higher) and with poor sleep quality (group 2: those with PSQI below 5). The Sociodemographic Form, Short Form 36 (SF-36), The Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ) and the Pittsburgh Sleep Quality Index (PSQI) were used in the evaluation of the data within one hour.
In present study there are two arm.
Arm 1: Patients with good sleep quality.
Arm 2: Patients with poor sleep quality.
Intervention code [1] 300026 0
Early Detection / Screening
Comparator / control treatment
Comparator/control treatment. We will compare between patients with a good sleep quality and with poor sleep quality in the same group on low back pain. .
Control group
Active

Outcomes
Primary outcome [1] 304437 0
We will create an observational study to evaluate the quality of sleep of patients having applied to pain clinic with complaint of low back pain by using the Pittsburgh Sleep Quality Index (PSQI).
Timepoint [1] 304437 0
Only one measurement. The patients with low back pain appling to pain clinic were given questionnaires and taken 15 minutes later.
Secondary outcome [1] 344189 0
We will create an observational study to evaluate the quality of life of patients having applied to pain clinic with complaint of low back pain by using The Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ) questionnaires.
Timepoint [1] 344189 0
Only one measurement. The patients with low back pain appling to pain clinic were given questionnaires and taken 15 minutes later.

Eligibility
Key inclusion criteria
Key inclusion criteria
1-Aged 18 - to 65 years old
2-Presence of low back pain
3-No chronic psychiatric illness
4-No liver failure.
5- No renal failure.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-chronic psychiatric diseases
2-metabolic diseases

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
All data will be analyzed by the Statistical Package for the Social Sciences (SPSS) version 16 (SPSS Inc., Chicago, IL, USA). In the comparison of the means between the groups, the t-test will be used when the normal distribution characteristics are provided; in the other case Mann-Whitney U test and Kruskal Wallis; in the comparison of the ratios between the groups, the chi square test; Spearman or Pearson correlation tests will be used according to the convenience of the distribution for the correlation analysis.The data will be evaluated at a 95% confidence interval..

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/04/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 9489 0
Turkey
State/province [1] 9489 0
Diyarbakir

Funding & Sponsors
Funding source category [1] 298383 0
Self funded/Unfunded
Name [1] 298383 0
Erhan Gökçek
Country [1] 298383 0
Turkey
Primary sponsor type
Individual
Name
Erhan Gökçek
Address
Diyarbakir State Hospital, departman of anesthesiology, Yenisehir Mahallesi, Dr. Seref Inal Öz Cad., Yenisehir/Diyarbakir post code:21100
Country
Turkey
Secondary sponsor category [1] 297509 0
None
Name [1] 297509 0
Address [1] 297509 0
Country [1] 297509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299377 0
Diyarbakir Gazi Yasargil Education and Training Hospital
Ethics committee address [1] 299377 0
Diyarbakir Gazi Yasargil Egitim Arastirma Hastanesi etik kurulu Talaytepe Mahallesi, Elazig Yolu Üzeri 10.Km, Kayapinar Üçkuyular/Kayapinar/Diyarbakir post code:21010
Ethics committee country [1] 299377 0
Turkey
Date submitted for ethics approval [1] 299377 0
15/12/2017
Approval date [1] 299377 0
29/12/2017
Ethics approval number [1] 299377 0
2017/90

Summary
Brief summary
In this study, it is aimed to evaluate the sleep and quality of life of the individuals who’ve applied to pain clinic with complaints of low back pain. This prospective observational study will be carried out at the pain clinic in Diyarbakir State Hospital between April and June 2018. Fifty adult patients aged between 18 and 65 were included in the study. Questionnaires were distributed to the patients in polyclinic of the pain and according to the results of these questionnaires, patients were divided into two groups with good sleep quality (group 1: PSQI 5 and higher) and with poor sleep quality (group 2: those with PSQI below 5). The Sociodemographic Form, Short Form 36 (SF-36), The Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ) and the Pittsburgh Sleep Quality Index (PSQI) were used in the evaluation of the data.The results of the study show that it is important to evaluate individuals with low back pain in terms of the quality of sleep and life.
Arm 1: Patients with the quality of good sleep.
Arm 2: Patients with the quality of poor sleep.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80222 0
Dr Erhan Gökçek
Address 80222 0
Diyarbakir State Hospital, departman of anesthesiology, Yenisehir Mahallesi, Dr. Seref Inal Öz Cad., Yenisehir/Diyarbakir post code:21100
Country 80222 0
Turkey
Phone 80222 0
+905074453164
Fax 80222 0
+90412 228 9193
Email 80222 0
gokcekerhan_44@hotmail.com
Contact person for public queries
Name 80223 0
Dr Erhan Gökçek
Address 80223 0
Diyarbakir State Hospital, departman of anesthesiology, Yenisehir Mahallesi, Dr. Seref Inal Öz Cad., Yenisehir/Diyarbakir post code:21100
Country 80223 0
Turkey
Phone 80223 0
+905074453164
Fax 80223 0
+90412 228 9193
Email 80223 0
gokcekerhan_44@hotmail.com
Contact person for scientific queries
Name 80224 0
Dr Erhan Gökçek
Address 80224 0
Diyarbakir State Hospital, departman of anesthesiology, Yenisehir Mahallesi, Dr. Seref Inal Öz Cad., Yenisehir/Diyarbakir post code:21100
Country 80224 0
Turkey
Phone 80224 0
+905074453164
Fax 80224 0
+90412 228 9193
Email 80224 0
gokcekerhan_44@hotmail.com

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No Supporting Document Provided



Results publications and other study-related documents

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