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RecruitingNCT07696260Updated Aug 12, 2026

Evaluation of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia

An observational study in Chronic Coccydynia and Alexithymia, sponsored by Marmara University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Marmara University · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Affective Symptoms with a site in Turkey — 4 open to participants now, 5 under way, none of them phase 3. Affective Symptoms · Turkey.

Started
2026
with 5 others
Observational
5 of 15
2 open now
Registered
11th of 15
by date
Lead sponsor
3 of 15
Marmara University

Among the 15 studies in Affective Symptoms with a site in Turkey, this one is one of 6 that started in 2026, is one of 5 observational ones, and was the 11th registered.

By phase

15 studies; the count open now beside each. This study's row is marked.

No phase10 · 2 open
Observationalthis study5 · 2 open

By the year they started

First in 2016; this study’s year is marked. 6 started in 2026.

Size and results

Median enrollment 65 across the 10 interventional studies, 70 across the 5 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 15 studies in Affective Symptoms with a site in Turkey, or all of them as a file.
02

Study summary

This study aims to investigate the prevalence and levels of alexithymia in patients diagnosed with chronic coccydynia (tailbone pain lasting for 3 months or longer) and to explore its relationship with various clinical and psychological parameters. Chronic coccydynia can significantly impair daily activities, functionality, and reduce quality of life. Participants in this prospective, observational study will be evaluated during their routine visits to the pain management clinic. Evaluation of the participants will be performed using validated self-report questionnaires, including the Toronto Alexithymia Scale (TAS-20) for alexithymia, the Hospital Anxiety and Depression Scale (HADS) for mood symptoms, the Childhood Trauma Questionnaire (CTQ-33) for early life adverse experiences, the Visual Analog Scale (VAS) for pain intensity, and the 12-Item Short Form Health Survey (SF-12) for quality of life. The primary objective of the study is to determine how alexithymia relates to pain severity, duration, emotional symptoms, childhood trauma history, and overall quality of life in this specific population. The results of this pilot study may help strengthen the biopsychosocial approach in the evaluation of chronic coccydynia and optimize future multidisciplinary treatment strategies.

Read the detailed description

Chronic coccydynia is a persistent pain condition localized to the coccygeal region, often exacerbated by sitting and significantly impairing daily activities, functionality, and health-related quality of life. While biomechanical and structural variables play a substantial role in its etiology, the pain can become chronic, making it difficult to explain solely through structural changes. Chronic pain is a complex phenomenon that interacts bidirectionally with cognitive-emotional processes and stress response systems. Within this framework, alexithymia-characterized by difficulty identifying and describing emotions-has been recognized as a psychological trait associated with higher pain intensity and functional interference in chronic pain populations.

The relationship between chronic pain, anxiety, depressive symptoms, and early adverse life events such as childhood trauma is also clinically critical, as these factors can amplify pain perception and restriction of activities. Despite these known associations in general chronic pain conditions, studies comprehensively evaluating alexithymia levels alongside pain duration, mood symptoms, childhood trauma history, and quality of life specifically within the coccydynia population remain limited. This gap in the literature underscores the importance of systematically examining the biopsychosocial components of chronic coccydynia to help optimize multidisciplinary treatment planning.

This prospective, observational cohort study aims to investigate the presence and levels of alexithymia in patients with chronic coccydynia (≥3 months) and to analyze its relationship with clinical and psychological variables. Patients presenting with tailbone pain will be evaluated at the multidisciplinary clinics. Following written informed consent, data collection will be completed in a single session utilizing a comprehensive battery of validated psychometric instruments. These include the Visual Analog Scale (VAS) for pain intensity, the 20-item Toronto Alexithymia Scale (TAS-20), the Hospital Anxiety and Depression Scale (HADS), the 33-item Childhood Trauma Questionnaire (CTQ-33), and the 12-item Short-Form Health Survey (SF-12). The findings are expected to contribute to the early identification of high-risk patient subgroups and strengthen the integration of supportive psychosocial interventions into future chronic pain management protocols.

03

Conditions studied

  • Chronic Coccydynia
  • Alexithymia

Keywords

  • Chronic coccydynia
  • Alexithymia
  • Childhood Trauma
  • Chronic Pain
  • Quality of Life
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients aged 18 and older who present to the algology outpatient clinic and meet the diagnostic criteria for chronic coccydynia lasting for 3 months or longer.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Being older than 18 years of age

  • Volunteering to participate in the study and providing written
  • Being literate and having the mental capacity to comprehend the questionnaires
  • Having no active, treated severe psychiatric disorder (such as schizophrenia or bipolar affective disorder)

Exclusion criteria

Exclusion Criteria:

  • - Cognitive impairment or communication barriers that compromise the capacity to consent
  • Active psychotic disorder or manic episode
  • Suspected self-harm or suicide risk during the clinical interview
  • Distinct secondary causes of pain such as , active infection, or acute fracture
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • Chronic Coccydynia Patients

    Patients aged 18 and older who present to the algology outpatient clinic with a diagnosis of chronic coccydynia lasting for 3 months or longer. Participants will undergo a single-time biopsychosocial assessment using validated psychometric scales including TAS-20, HADS, CTQ-33, VAS, and SF-12 during their routine evaluation.

06

What researchers measure

Primary outcomes

  1. Toronto Alexithymia Scale (TAS-20) Score

    A 20-item self-report questionnaire used to evaluate the presence and severity of alexithymia. It assesses three subscales: difficulty identifying feelings, difficulty describing feelings, and externally-oriented thinking. Total scores range from 20 to 100, where higher scores indicate a higher level of alexithymia.

    Time frame: Baseline (Single-time assessment during the clinical interview)

Secondary outcomes

  1. Visual Analog Scale (VAS) for Pain

    A 10-cm horizontal scale used to measure pain intensity. Scores range from 0 (no pain) to 10 (worst possible pain). Participants indicate their current tailbone pain level on this line.

    Time frame: Baseline (Single-time assessment)

  2. Hospital Anxiety and Depression Scale (HADS) Score

    A 14-item self-report questionnaire consisting of two subscales: anxiety (7 items) and depression (7 items). Each subscale is scored from 0 to 21, where higher scores reflect greater severity of anxiety or depression. Cut-off scores are 10 for anxiety and 7 for depression.

    Time frame: Baseline (Single-time assessment)

  3. Childhood Trauma Questionnaire (CTQ-33) Score

    A 33-item scale evaluating retrospective childhood and adolescent adverse experiences. It assesses emotional abuse, physical abuse, sexual abuse, emotional neglect, physical neglect, and overprotection-control. Total scores range from 25 to 150, with higher scores representing more severe childhood trauma.

    Time frame: Baseline (Single-time assessment)

  4. Short Form Health Survey (SF-12) Score

    A 12-item health-related quality of life survey consisting of 8 domains. Total and component scores range from 0 to 100, where higher scores indicate better health-related quality of life.

    Time frame: Baseline (Single-time assessment)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2026
First posted
Jul 10, 2026
StartActual
Mar 20, 2026
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07696260
Lead sponsor
Marmara University
Responsible party
Haner Direskeneli (Professor, MD, Marmara University) — Principal investigator
First posted
Jul 10, 2026
Start date
Mar 20, 2026
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Aug 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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