The Relationship of Disability With Depression, Anxiety and Sleep Quality in Patients With Coccygodynia
1 other identifier
observational
54
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedSeptember 27, 2021
September 1, 2021
9 months
August 31, 2021
September 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Study Arms (1)
coccycodinia group
A total of 54 patients diagnosed with coccycodinia
Interventions
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.
Eligibility Criteria
Patients who applied to Sivas Cumhuriyet University Faculty of Medicine, Physical Therapy and Rehabilitation Clinic between 01/08/2021-30/04/2022 and diagnosed with coccygodynia will be included in the study
You may qualify if:
- Diagnosed with coccygodynia
- Agreement to take part in the study 18 to 70 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emel Guler
Sivas, Turkey (Türkiye)
Related 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.
PMID: 27037436BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emel Güler, MD
Cumhuriyet University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 17, 2021
Study Start
August 1, 2021
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
September 27, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share