The Relationship of Disability With Depression, Anxiety and Sleep Quality in Patients With Coccygodynia

Depression Clinical Trial

Official title:

The Relationship of Disability With Depression, Anxiety and Sleep Quality in Patients With Coccygodynia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05047380
• Other study ID #: 2021-06/20
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: September 2021
• Source: Sivas Cumhuriyet University
• Contact: Emel Güler, MD
• Phone: +905356492951
• Email: dremelguler[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Pain of the sacrococcygeal region is called coccygodynia This painful clinical picture, which causes a decrease in the quality of life, also causes disability. Coccycodynia has been associated with hysteria, neurosis, and depression. In some studies, it has been reported that it should be evaluated in somatization in coccygodynia. There are a few studies examining the relationship between coccygodynia and psychiatric disorders.There is no study in the literature examining coccygodynia and sleep. There may be a relationship between pelvic floor muscle spasm in the etiology of coccygodynia and sleep quality. In this study, it is aimed to investigate the relationship between disability severity and anxiety, depression and sleep quality in patients with coccygodynia.

Description:

Coccygodynia often develops from an inappropriate sitting position or when standing up from a sitting position. In the advanced stages of coccygodynia the pain becomes continuous. Pain can be triggered by walking or standing for a long time. Patients may experience sacrococcygeal pain in the supine position and during sleep. It has been argued that the coexistence of coccygodynia and psychiatric disease is caused by the excessive activity of the pelvic region nerves. In addition, it has been stated that stress, depression and fear may lead to increased spasm in the pelvic floor muscles.It is stated in the literature that 62.9-75% of patients with chronic pain have at least one psychiatric disorder. The most common psychiatric comorbidities in patients with chronic pain are; major depression, somatoform disorders, and generalized anxiety disorder. The relationship between pain and psychological variables has been attributed to the fact that the sensorial pathways of pain and mood regulation are located in the same region of the brain. In addition, common neurotransmitters such as serotonin, norepinephrine and dopamine are present in the pathophysiology of depression and pain.There is a bidirectional relationship between sleep and pain. In recent studies; It has been reported that sleep disorder causes pain development rather than the effect of pain on sleep disorder.

54 patients with coccydynia will be recruited prospectively according to the appropriate inclusion and exclusion criteria.Within the scope of the study, the age, gender, duration of symptoms, etiology of coccygodynia, and severity of pain will be recorded. The Oswestry Disability Index scale will be filled in to assess the severity of disability resulting from pain in the patient. Pain severity will be evaluated with the Visual Analog Scale (VAS). Depression and anxiety assessment will be made with Beck Depression Scale and Beck Anxiety Scale, respectively. Sleep quality will be evaluated with the Pittsburg Sleep Quality Index.

The data will be entered into the SPSS (version: 22.0) IBM SPSS statistical package program. Arithmetic mean, standard deviation, min-max, median values will be given in the data obtained by measurement. Percentage and frequency distribution will be given in the data obtained by counting. In statistical evaluations, parametric tests will be used for normally distributed data, and non-parametric tests will be used for data not normally distributed. Relationships will be compared according to the Pearson or Spearman correlation coefficient. Chi-square test will be applied to categorical data. P<0.05 will be considered significant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed with coccygodynia

• Agreement to take part in the study 18 to 70 years old

Exclusion Criteria:

• Presence of cognitive impairment that would limit answering the questions in the questionnaires

• History of psychotic disorder

• History of neurological disease (cerebrovascular accident, polyneuropathy, parkinson's, dementia, epilepsy),

• History of rheumatological disease, fibromyalgia and malignancy

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Chronic Pain
• Depression
• Depressive Disorder
• Pain, Chronic
• Sleep
• Sleep Hygiene

Intervention

Behavioral:
• Owstery Disability Scale for disability Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, VAS for pain, Pittsburgh Sleep Quality Scale for sleep quality
All assessments will be made using questionairres. The Oswestry Disability Index scale will be filled in to assess the severity of disability resulting from pain in the patient. Pain severity will be evaluated with the Visual Analog Scale (VAS). Depression and anxiety assessment will be made with Beck Depression Scale and Beck Anxiety Scale, respectively. Sleep quality will be evaluated with the Pittsburg Sleep Quality Index.

Locations

Country	Name	City	State
Turkey	Emel Guler	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Sivas Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Hanley EN, Ode G, Jackson Iii BJ, Seymour R. Coccygectomy for patients with chronic coccydynia: a prospective, observational study of 98 patients. Bone Joint J. 2016 Apr;98-B(4):526-33. doi: 10.1302/0301-620X.98B4.36641. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and depression	Beck Depression Scale will be used in depression interrogation. =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.	The study will be completed in 9 months.
Primary	Sleep quality	Sleep quality will be questioned with The Pittsburgh Sleep Quality Index. Those who score ?5 have poor sleep quality, and those who score =5 have "good sleep quality".	The study will be completed in 9 months.

External Links

•   preoperative psychiatric disorders were detected in most of the patients who underwent coccygectomy.