The Relationship of Psychological Factors and Sleep Quality With the Severity of Carpal Tunnel Syndrome

Sponsor
Cumhuriyet University (Other)
Overall Status
Completed
CT.gov ID
NCT05047367
Collaborator
(none)
149
1
6.2
24.1

Study Details

Study Description

Brief Summary

The most common entrapment neuropathy symptoms, the diagnosis of CTS, is determined by examination findings and by means of the results of electro-diagnostic test. With an increase in disease severity, trap neuropathy, whose symptoms are more pronounced at night, negatively affects the daily life of the person. Deterioration in sleep quality may cause depression and anxiety. Conflicting results have been found in the studies related to these findings. However, no study was found in which daytime sleepiness was evaluated in terms of CTS. The investigators aim in this study is to evaluate the relationship between CTS severity and depression, anxiety, sleep quality and daytime sleepiness.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: cross-sectional survey study

Detailed Description

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy with an incidence of 2.7-4%. CTS, resulting from compression of the median nerve in the wrist, clinically progresses with tingling, numbness matching the nerve trace, and motor deficit in the presence of progressive nerve damage. Accordingly, the incidence of neuropathic pain is increasing. In addition to these symptoms mentioned, electro-diagnostic tests are used for diagnostic purposes and to determine the severity of nerve compression, and as a result, there are different types of classification, but most commonly CTS is classified as mild, moderate and severe. This classification is of great importance for the regulation of the follow-up and treatment protocol and making the association of existing complaints with the disease. Studies have shown that approximately 80% of CTS patients wake up at night due to numbness in the hand, resulting in deterioration in sleep quality. Impairment of sleep quality may cause increased sympathetic nervous system activity and awakening of physical and psychological stressors. Deterioration in sleep quality may cause depression and anxiety. Conflicting results have been found in the studies related to these findings. However, no study was found in which daytime sleepiness was evaluated in terms of CTS. The investigators aim in this study is to evaluate the relationship between CTS severity and depression, anxiety, sleep quality and daytime sleepiness. This study;149 patients with a diagnosis of CTS were prospectively included in the study. Electro-diagnostic test results were used to determine the severity of the disease. In this context, Boston CTS rating scale was used to evaluate the functional and symptomatic effects, Pittsburgh sleep quality scale and Epworth sleepiness scale were used to evaluate sleep quality and daytime sleepiness, and pain DETECT questionnaire was used to evaluate pain type.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
149 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Relationship of Psychological Factors and Sleep Quality With the Severity of Carpal Tunnel Syndrome
Actual Study Start Date :
Jan 13, 2021
Actual Primary Completion Date :
Jul 19, 2021
Actual Study Completion Date :
Jul 20, 2021

Arms and Interventions

Arm Intervention/Treatment
single-group studies

A total of 149 patients diagnosed with CTS, 126 female and 23 male, were included in the study

Behavioral: cross-sectional survey study
Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, Visual Analogue Scale and PainDETECT Questionnaire for pain, Pittsburgh Sleep Quality Scale and Epworth Sleepiness Scale for sleep quality
Other Names:
  • all patients were filled out forms for sleep quality and psychological evaluation
  • Outcome Measures

    Primary Outcome Measures

    1. Severity of Carpal Tunnel Syndrome [study completion,an average of six months]

      Electromyography evaluation of patients

    2. The correlation between severity of Carpal Tunnel Syndrome and psychological evaluation [study completion,an average of six months]

      Beck Depression Scale, Beck Anxiety Scale will be used for psychological evaluation. ≤9 points are classified as normal,10-16 points as mild depression,17-29 points as moderate depression, and 30-63 points as severe depression.Beck Anxiety Scale will be used in anxiety interrogation. ≤9 points are classified as normal, 10-18 points as mild anxiety, 19-29 points as moderate anxiety, and 30-63 points as severe anxiety.

    3. The correlation between severity of Carpal Tunnel Syndrome and pain intensity [study completion,an average of six months]

      Visual Analog Scale will be used for pain intensity.It is scored between 0-10. =: no pain 10: defined as the most severe pain

    4. The correlation between severity of Carpal Tunnel Syndrome and neuropathic pain [study completion,an average of six months]

      PainDETECT Questionnaire will be used for neuropathic pain evaluation.The questionnaire score ranges from 0-35 points, and a score of 19 and above indicates the presence of neuropathic pain.

    5. The correlation between severity of Carpal Tunnel Syndrome and sleep quality [study completion,an average of six months]

      Pittsburgh Sleep Quality Scale will be used for sleep quality. Those who score ˃5 have poor sleep quality, and those who score ≤5 have "good sleep quality"

    6. The correlation between severity of Carpal Tunnel Syndrome and sleepiness [study completion,an average of six months]

      Epworth Sleepiness Scale will be used for sleepiness. It is scored between 0-28. As the total score increases, sleepiness increases.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients aged 18-75 years diagnosed with CTS.

    • Patients who were mentally able to respond to the assessment questionnaires were also included

    Exclusion Criteria:
    • Clinical diagnosis of cervical radiculopathy/plexopathy findings

    • Pregnancy

    • Diabetes mellitus

    • thyroid diseases

    • amyloidosis

    • collagen tissue diseases

    • Obstructive sleep apnea

    • History of the upper extremity trauma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emel Guler Sivas Turkey

    Sponsors and Collaborators

    • Cumhuriyet University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emel Güler, Asst Prof, Cumhuriyet University
    ClinicalTrials.gov Identifier:
    NCT05047367
    Other Study ID Numbers:
    • 2021-01/39
    First Posted:
    Sep 17, 2021
    Last Update Posted:
    Sep 27, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Emel Güler, Asst Prof, Cumhuriyet University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 27, 2021