Musculoskeletal InjuryNCT06605170
Reliability and Validity of the Traumatic Injuries Distress Scale to Turkish
An observational study of Musculoskeletal Injury and Trauma Injury, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
The Traumatic Injuries distress Scale is a patient-reported measure that assesses suffering following non-catastrophic musculoskeletal injuries. The original English version demonstrated acceptable accuracy in predicting recovery trajectories up to 12 months later. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Musculoskeletal Injury, Trauma Injury
- What is being tested?
- Questionnaire
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2024to 22 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those who have suffered traumatic musculoskeletal injuries that do not require surgery or inpatient treatment
Who may be able to join
- At least 18 years old,
- Having good reading and writing skills in Turkish,
- Having suffered a traumatic musculoskeletal injury that does not require surgery or inpatient treatment
- At least 2 and at most 4 weeks have passed since the injury
Who cannot join
- Those with organ disease
- Those with blood clotting disorders
- Those with neuromuscular disorders
- Those with rheumatoid diseases
- Those with cancer
- Those with systemic diseases such as uncontrollable psychopathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation, Cross-cultural Adaptation, Reliability and Validity of the Traumatic Injuries Distress Scale to Turkish
The Traumatic Injuries distress Scale is a patient-reported measure that assesses suffering following non-catastrophic musculoskeletal injuries. The original English version demonstrated acceptable accuracy in predicting recovery trajectories up to 12 months later. This study aimed to determine the cultural adaptation, validity and reliability of the Turkish version of TIDS-TR in young and physically active patients with hip pain.
Read the detailed description
The Traumatic Injuries distress Scale (TIDS) is commonly used to measure methods of coping with various forms of Traumatic Injuries. TIDS is a self-report questionnaire developed by David M. Walton et al. in 2016 to assess the magnitude of stress experienced as a result of recent musculoskeletal trauma. It is administered between 2 days and 4 weeks after injury and is used to estimate the likelihood of recovery within 6 to 12 months. Each item in the TIDS questionnaire, which consists of 12 items, is scored as 0, 1, or 2, and the total score is at least 0 and at most 24. The total TIDS score is interpreted as low risk (≤ 3), medium or unknown risk (4 to 10), and high risk (≥ 11) according to the score obtained. TIDS consists of three subscales: 1) uncontrolled pain (4 items), 2) negative affect (6 items), and 3) intrusion/hyperarousal (2 items). Each of the subscales has guiding features for clinicians to determine treatment priorities such as pain management, cognitive or psychological intervention, and stress management techniques. It is recommended that when the uncontrolled pain subscale score is 3 and above, the applications should be aimed at symptom control, when the negative affect score is 3 and above, the applications should be aimed at correcting negative mood, and when the intrusion/hyperarousal score is 1 and above, the applications should be aimed at treating anxiety and post-traumatic stress disorder.
The questionnaires validity and reliability were examined, and good findings were found, leading to the tools widespread use. The purpose of this study was to translate and culturally adapt the original English version of the TIDS into Turkish, as well as to evaluate the instruments validity and reliability in patients with traumatic musculoskeletal injury.
- Conditions
- Musculoskeletal Injury, Trauma Injury
- Being tested
- Questionnaire
- Keywords
- TIDS, Reliability, Validity, TIDS-TR
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Translate and culturally adapt the original English version of the traumatic injuries distress scale to Turkish
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of the patients
Age will be recorded.
Measured: 4 weeks
Gender of the patients
Gender will be recorded.
Measured: 4 weeks
body mass index of the patients
body mass index will be recorded.
Measured: 4 weeks
education level of the patients
education level will be recorded.
Measured: 4 weeks
employment status of the patients
employment status will be recorded.
Measured: 4 weeks
duration of pain of the patients
duration of pain will be recorded.
Measured: 4 weeks
duration, type and location of pain of the patients
duration, type and location of pain will be recorded.
Measured: 4 weeks
type of injury of the patients
type of injury will be recorded.
Measured: 4 weeks
mechanism of injury of the patients
mechanism of injury will be recorded.
Measured: 4 weeks
Traumatic Injuries Distress Scale
Traumatic Injuries Distress Scale questionnaire will be filled out under the supervision of a physiotherapist.
Measured: 4 weeks
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) questionnaire will be filled out under the supervision of a physiotherapist.
Measured: 4 weeks
Short Form-12 (SF-12)
Short Form-12 (SF-12) questionnaire will be filled out under the supervision of a physiotherapist.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start30 Sep 2024
- Primary completion15 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Mahmut GÜNAY, Uludag University
- Investigators
- Selim Mahmut GÜNAY, Dr, Study chair, Uludağ University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605170
- Sponsor's protocol ID
- 2020-13/21
- Status last verified
- Dec 2024
- First submitted
- 12 Sep 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Walton DM, Krebs D, Moulden D, Wade P, Levesque L, Elliott J, MacDermid JC. The Traumatic Injuries Distress Scale: A New Tool That Quantifies Distress and Has Predictive Validity With Patient-Reported Outcomes. J Orthop Sports Phys Ther. 2016 Oct;46(10):920-928. doi: 10.2519/jospt.2016.6594. Epub 2016 Sep 3.
PubMed 27594662
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cross-cultural Adaptation, Reliability and Validity of the Traumatic Injuries Distress Scale to Turkish
- ClinicalTrials.gov ID
- NCT06605170
- Acronym / sponsor ID
- 2020-13/21
- Conditions
- Musculoskeletal Injury, Trauma Injury
- Keywords
- TIDS, Reliability, Validity, TIDS-TR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Traumatic Injuries distress Scale is a patient-reported measure that assesses suffering following non-catastrophic musculoskeletal injuries. The original English version demonstrated acceptable accuracy in predicting recovery trajectories up to 12 months later. This study aimed to determine the cultural adaptation, validity and reliability of the Turkish version of TIDS-TR in young and physically active patients with hip pain.
Detailed description
The Traumatic Injuries distress Scale (TIDS) is commonly used to measure methods of coping with various forms of Traumatic Injuries. TIDS is a self-report questionnaire developed by David M. Walton et al. in 2016 to assess the magnitude of stress experienced as a result of recent musculoskeletal trauma. It is administered between 2 days and 4 weeks after injury and is used to estimate the likelihood of recovery within 6 to 12 months. Each item in the TIDS questionnaire, which consists of 12 items, is scored as 0, 1, or 2, and the total score is at least 0 and at most 24. The total TIDS score is interpreted as low risk (≤ 3), medium or unknown risk (4 to 10), and high risk (≥ 11) according to the score obtained. TIDS consists of three subscales: 1) uncontrolled pain (4 items), 2) negative affect (6 items), and 3) intrusion/hyperarousal (2 items). Each of the subscales has guiding features for clinicians to determine treatment priorities such as pain management, cognitive or psychological intervention, and stress management techniques. It is recommended that when the uncontrolled pain subscale score is 3 and above, the applications should be aimed at symptom control, when the negative affect score is 3 and above, the applications should be aimed at correcting negative mood, and when the intrusion/hyperarousal score is 1 and above, the applications should be aimed at treating anxiety and post-traumatic stress disorder.
The questionnaires validity and reliability were examined, and good findings were found, leading to the tools widespread use. The purpose of this study was to translate and culturally adapt the original English version of the TIDS into Turkish, as well as to evaluate the instruments validity and reliability in patients with traumatic musculoskeletal injury.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those who have suffered traumatic musculoskeletal injuries that do not require surgery or inpatient treatment
Key inclusion criteria (4 listed)
- At least 18 years old,
- Having good reading and writing skills in Turkish,
- Having suffered a traumatic musculoskeletal injury that does not require surgery or inpatient treatment
- At least 2 and at most 4 weeks have passed since the injury
Key exclusion criteria (6 listed)
- Those with organ disease
- Those with blood clotting disorders
- Those with neuromuscular disorders
- Those with rheumatoid diseases
- Those with cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireTranslate and culturally adapt the original English version of the traumatic injuries distress scale to Turkish | Other | – |
Primary outcome
Age of the patients
Time frame: 4 weeks
Age will be recorded.
Gender of the patients
Time frame: 4 weeks
Gender will be recorded.
body mass index of the patients
Time frame: 4 weeks
body mass index will be recorded.
education level of the patients
Time frame: 4 weeks
education level will be recorded.
employment status of the patients
Time frame: 4 weeks
employment status will be recorded.
duration of pain of the patients
Time frame: 4 weeks
duration of pain will be recorded.
duration, type and location of pain of the patients
Time frame: 4 weeks
duration, type and location of pain will be recorded.
type of injury of the patients
Time frame: 4 weeks
type of injury will be recorded.
mechanism of injury of the patients
Time frame: 4 weeks
mechanism of injury will be recorded.
Traumatic Injuries Distress Scale
Time frame: 4 weeks
Traumatic Injuries Distress Scale questionnaire will be filled out under the supervision of a physiotherapist.
Hospital Anxiety and Depression Scale (HADS)
Time frame: 4 weeks
Hospital Anxiety and Depression Scale (HADS) questionnaire will be filled out under the supervision of a physiotherapist.
Short Form-12 (SF-12)
Time frame: 4 weeks
Short Form-12 (SF-12) questionnaire will be filled out under the supervision of a physiotherapist.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 27594662Walton DM, Krebs D, Moulden D, Wade P, Levesque L, Elliott J, MacDermid JC. The Traumatic Injuries Distress Scale: A New Tool That Quantifies Distress and Has Predictive Validity With Patient-Reported Outcomes. J Orthop Sports Phys Ther. 2016 Oct;46(10):920-928. doi: 10.2519/jospt.2016.6594. Epub 2016 Sep 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim Mahmut GÜNAY, Dr study chair
Uludağ University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Injury and Trauma Injury, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age of the patients (time frame: 4 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06605170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.