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

NCT05047367 | Completed

• 1 other identifier: 2021-01/39
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Depressive Symptoms; Sleepiness; Anxiety; Sleep; Pain, Neuropathic

Keywords

CTS,Psychological factors,Sleep quality,Daytime Sleepiness

Outcome Measures

Primary Outcomes (6)

• Severity of Carpal Tunnel Syndrome

  Electromyography evaluation of patients

  study completion,an average of six months

• The correlation between severity of Carpal Tunnel Syndrome and psychological evaluation

  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.

  study completion,an average of six months

• The correlation between severity of Carpal Tunnel Syndrome and pain intensity

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

  study completion,an average of six months

• The correlation between severity of Carpal Tunnel Syndrome and neuropathic pain

  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.

  study completion,an average of six months

• The correlation between severity of Carpal Tunnel Syndrome and sleep quality

  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"

  study completion,an average of six months

• The correlation between severity of Carpal Tunnel Syndrome and sleepiness

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

  study completion,an average of six months

Study Arms (1)

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

Interventions

cross-sectional survey study BEHAVIORAL

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

Also known as: all patients were filled out forms for sleep quality and psychological evaluation

single-group studies

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with CTS

You may qualify if:

• Patients aged 18-75 years diagnosed with CTS.
• Patients who were mentally able to respond to the assessment questionnaires were also included

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Emel Guler

Sivas, Turkey (Türkiye)

Location

Related Publications (1)

• Rubin G, Orbach H, Rinott M, Rozen N. Relationship between electrodiagnostic findings and sleep disturbance in carpal tunnel syndrome: A controlled objective and subjective study. J Int Med Res. 2020 Feb;48(2):300060519862673. doi: 10.1177/0300060519862673. Epub 2019 Jul 18.

  PMID: 31319726 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Depression; Sleepiness; Anxiety Disorders; Neuralgia

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: September 17, 2021
• Study Start: January 13, 2021
• Primary Completion: July 19, 2021
• Study Completion: July 20, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

TU (1)