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

NCT ID: NCT05047380

Last Updated: 2021-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coccyx Injuries Pain, Chronic Anxiety Depression Sleep Sleep Hygiene

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

coccycodinia group

A total of 54 patients diagnosed with coccycodinia

Owstery Disability Scale for disability Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, VAS for pain, Pittsburgh Sleep Quality Scale for sleep quality

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cumhuriyet University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emel Güler

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emel Güler, MD

Role: PRINCIPAL_INVESTIGATOR

Cumhuriyet University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Emel Guler

Sivas, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Emel Güler, MD

Role: CONTACT

+905356492951

Hanzade A Ünal-Artık, MD

Role: CONTACT

+905057179039

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

emel guler

Role: primary

+905356492951

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27037436 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/27037436/

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-06/20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Podcast Training on Birth Fear in Couples
NCT06929975 ENROLLING_BY_INVITATION NA
Showering During Labor
NCT05529823 COMPLETED NA