Sports InjuriesPAMIISNCT06955364
Development Study of Pain Monitoring and Injury Impact Scale
An observational study of Sports Injuries and Social Impact, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
This study introduced and validated the Pain Monitoring and Injury Impact Scale for Athletes (PAMIIS), developed to address the lack of a comprehensive tool in Turkish for assessing injury-related pain and its multidimensional impact on athletes.The development process involved expert consultations, literature review… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sports Injuries, Social Impact, Psychological Impact of Injury
- How many people
- 268 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Jun 2022to 23 May 2023
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All athletes who regularly participate in a sporting activity for more than six months, aged 13 or over, and Turkish-speaking.
Who may be able to join
- Engaged in regular participation in any form of sporting activity for a minimum duration of six months
- Aged 13 years or older
- Had sufficient proficiency in the Turkish language to comprehend and respond to the study materials
- Voluntarily agreed to participate in the study, with informed consent obtained
Who cannot join
- Pregnancy or illiteracy
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Medipol University
Ankara, Çankaya, 006450
Gazi University
Ankara, Çankaya, 006450
About this study
Official title: A New Measurement Tool for Investigation of Pain Monitoring and Post-Injury Effects in Athletes
This study introduced and validated the Pain Monitoring and Injury Impact Scale for Athletes (PAMIIS), developed to address the lack of a comprehensive tool in Turkish for assessing injury-related pain and its multidimensional impact on athletes.The development process involved expert consultations, literature review, and feedback from athletes, resulting in a 37-item pool that was refined through pilot testing. Psychometric analyses conducted with 148 athletes demonstrated strong internal consistency, high test-retest reliability, and substantial correlations with established tools such as the Visual Analog Scale, OSTRC-O, and OSTRC-H. The final scale structure, consisting of 32 items across four subscales, was confirmed through both exploratory and confirmatory factor analyses. PAMIIS is a psychometrically sound instrument for systematically monitoring athletes' health status and documenting the short- and long-term consequences of sports injuries.
Read the detailed description
ABSTRACT Aims: In Turkish, there is no valid and reliable measurement tool for monitoring the health status of athletes and evaluating the effects of injuries on them from various dimensions. With this study, we aimed to develop a measurement tool to detect pain associated with sports injuries and to investigate the consequences of injury. We created a measurement tool called Pain Monitoring and Injury Impact Scale for Athletes-PAMIIS, which consists of a Pain Detection Diagram and an Injury Impact Scale.
Methods: PAMIIS was designed and improved upon expert, partner, and participant opinions and a literature review. Initially, a pool of 37 items was created. The content and scope of the tool were checked with a pilot test on 30 athletes. In the main test phase, 148 participants (200 sample) were tested for item consistency, and 55 athletes (70 sample) were retested for stability to determine reliability. For concurrent validity, PAMIIS sub-scores were compared with the Visual Analog Scale, the Oslo Sports Trauma Research Center Overuse Injury Questionnaire (OSTRC-O), and the Oslo Sports Trauma Research Center on Health Problems (OSTRC-H) scores. Scale structure revealed with Exploratory Factor Analysis (EFA) for the construct validity. In the final phase, 90 (122 sample) athletes were administered the restructured scale, and its construct was tested with Confirmatory Factor Analysis (CFA).
- Keywords
- Pain monitoring, Scale development, Performance, Participation
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Study (pretest) Group | In the pilot study, the comprehensibility and feedback forms were administered to 30 athletes from various branches to assess the content and face validity of PAMIIS. | |
| Main Testing Group | The new version of PAMIIS was administered to 148 athletes for consistency and construct validity with Exploratory Factor Analysis (EFA). OSTRC-O and OSTRC-H questionnaires were also applied to investigate the concurrent validity of PAMIIS. | |
| Retest Group | The scale was reapplied to 55 athletes in the main test group one week later to check its reproducibility. | |
| Final Test Group | The remodeled PAMIIS was applied to the 90 athletes for Confirmatory Factor Analysis (CFA) of the PAMIIS to ensure its construct validity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Monitoring and Injury Impact Scale (PAMIIS)
It is a two-tiered, self-reported scale designed to determine the health level of athletes through pain symptoms in all body parts and to investigate the physical, psychological, and social effects of injury on the athlete. The first tier of the scale includes a diagram that enables health monitoring and screening for athletes. This section involves querying the athlete about the presence of pain, if any, its localization, intensity, onset, progression, and its relationship with training. This section is designed to be repeated weekly in pain-free athletes to monitor changes in their condition. If the athlete is already injured or a painful condition is detected in the first tier, he is prompted to proceed to the second tier. Here, the Performance, Participation, Psychological, and Social impacts resulting from the injury are thoroughly investigated. An athlete gets a minimum of 0 and a maximum of 128 points on the injury impact scale. Higher points show worse health conditions.
Measured: Baseline
Secondary outcomes (3)
Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury (OSTRC-O)
The "Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury" is a self-reported outcome measure. It queries sports participation, training volume, sports performance, and pain for a selected body location-e.g. knee taking into account the last seven days. A severity score is between 0-100 points. Higher points show worse health conditions.
Measured: Baseline
Oslo Sports Trauma Research Centre questionnaires on Health Problems (OSTRC-H)
"Oslo Sports Trauma Research Centre questionnaires on Health Problems" is a self-reported outcome measure. It is applied to determine the effects of general health problems on sports participation, training volume, sports performance, and pain for the last seven days. A severity score is between 0 and 100 points. Higher points show worse health conditions
Measured: Baseline
Pain Monitoring and Injury Impact Scale (PAMIIS)
It is a two-tiered, self-reported scale designed to determine the health level of athletes through pain symptoms in all body parts and to investigate the physical, psychological, and social effects of injury on the athlete. The first tier of the scale includes a diagram that enables health monitoring and screening for athletes. This section involves querying the athlete about the presence of pain, if any, its localization, intensity, onset, progression, and its relationship with training. This section is designed to be repeated weekly in pain-free athletes to monitor changes in their condition. If the athlete is already injured or a painful condition is detected in the first tier, he is prompted to proceed to the second tier. Here, the Performance, Participation, Psychological, and Social impacts resulting from the injury are thoroughly investigated. An athlete gets a minimum of 0 and a maximum of 128 points on the injury impact scale. Higher points show worse health conditions.
Measured: one week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start8 Jun 2022
- Primary completion14 Feb 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sports InjuriesStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyda ÖZAL, Gazi University
- Investigators
- Şeyda YILMAZ ÖZAL, Assistant Professor, Principal investigator, Ankara Medipol UniversityNihan KARATAŞ, Professor, Study director, Gazi UniversityNevin ATALAY GÜZEL, Professor, Study chair, Gazi UniversityMelek Gülşah ŞAHİN, Professor, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955364
- Sponsor's protocol ID
- GaziUnivrs
- Acronym
- PAMIIS
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maffulli N, Longo UG, Gougoulias N, Caine D, Denaro V. Sport injuries: a review of outcomes. Br Med Bull. 2011;97:47-80. doi: 10.1093/bmb/ldq026. Epub 2010 Aug 14.
PubMed 20710023Meeuwisse WH. Assessing causation in sport injury: a multifactorial model. LWW; 1994. p. 166-170.
Yilmaz Ozal S, Kafa N, Yuksel F, Guzel N. Turkish translation and validation of the Oslo Sports Trauma Research Center (OSTRC) Questionnaires. Malawi Med J. 2025 Apr 2;37(1):44-50. doi: 10.4314/mmj.v37i1.7. eCollection 2025 Mar.
PubMed 41306359Özal Ş, Kafa N, Güzel NA, Development of a measurement tool for investigation of pain monitoring and post-injury effects in athletes, Gazi University Institute of the Health Science PhD thesis 2023/4
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Measurement Tool for Investigation of Pain Monitoring and Post-Injury Effects in Athletes
- ClinicalTrials.gov ID
- NCT06955364
- Acronym / sponsor ID
- PAMIIS / GaziUnivrs
- Keywords
- Pain monitoring, Scale development, Performance, Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 2 May 2025 (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.
This study introduced and validated the Pain Monitoring and Injury Impact Scale for Athletes (PAMIIS), developed to address the lack of a comprehensive tool in Turkish for assessing injury-related pain and its multidimensional impact on athletes.The development process involved expert consultations, literature review, and feedback from athletes, resulting in a 37-item pool that was refined through pilot testing. Psychometric analyses conducted with 148 athletes demonstrated strong internal consistency, high test-retest reliability, and substantial correlations with established tools such as the Visual Analog Scale, OSTRC-O, and OSTRC-H. The final scale structure, consisting of 32 items across four subscales, was confirmed through both exploratory and confirmatory factor analyses. PAMIIS is a psychometrically sound instrument for systematically monitoring athletes' health status and documenting the short- and long-term consequences of sports injuries.
Detailed description
ABSTRACT Aims: In Turkish, there is no valid and reliable measurement tool for monitoring the health status of athletes and evaluating the effects of injuries on them from various dimensions. With this study, we aimed to develop a measurement tool to detect pain associated with sports injuries and to investigate the consequences of injury. We created a measurement tool called Pain Monitoring and Injury Impact Scale for Athletes-PAMIIS, which consists of a Pain Detection Diagram and an Injury Impact Scale.
Methods: PAMIIS was designed and improved upon expert, partner, and participant opinions and a literature review. Initially, a pool of 37 items was created. The content and scope of the tool were checked with a pilot test on 30 athletes. In the main test phase, 148 participants (200 sample) were tested for item consistency, and 55 athletes (70 sample) were retested for stability to determine reliability. For concurrent validity, PAMIIS sub-scores were compared with the Visual Analog Scale, the Oslo Sports Trauma Research Center Overuse Injury Questionnaire (OSTRC-O), and the Oslo Sports Trauma Research Center on Health Problems (OSTRC-H) scores. Scale structure revealed with Exploratory Factor Analysis (EFA) for the construct validity. In the final phase, 90 (122 sample) athletes were administered the restructured scale, and its construct was tested with Confirmatory Factor Analysis (CFA).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pilot Study (pretest) Group | – | –In the pilot study, the comprehensibility and feedback forms were administered to 30 athletes from various branches to assess the content and face validity of PAMIIS. |
| Main Testing Group | – | –The new version of PAMIIS was administered to 148 athletes for consistency and construct validity with Exploratory Factor Analysis (EFA). OSTRC-O and OSTRC-H questionnaires were also applied to investigate the concurrent validity of PAMIIS. |
| Retest Group | – | –The scale was reapplied to 55 athletes in the main test group one week later to check its reproducibility. |
| Final Test Group | – | –The remodeled PAMIIS was applied to the 90 athletes for Confirmatory Factor Analysis (CFA) of the PAMIIS to ensure its construct validity |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All athletes who regularly participate in a sporting activity for more than six months, aged 13 or over, and Turkish-speaking.
Key inclusion criteria (4 listed)
- Engaged in regular participation in any form of sporting activity for a minimum duration of six months
- Aged 13 years or older
- Had sufficient proficiency in the Turkish language to comprehend and respond to the study materials
- Voluntarily agreed to participate in the study, with informed consent obtained
Key exclusion criteria (1 listed)
- Pregnancy or illiteracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Monitoring and Injury Impact Scale (PAMIIS)
Time frame: Baseline
It is a two-tiered, self-reported scale designed to determine the health level of athletes through pain symptoms in all body parts and to investigate the physical, psychological, and social effects of injury on the athlete. The first tier of the scale includes a diagram that enables health monitoring and screening for athletes. This section involves querying the athlete about the presence of pain, if any, its localization, intensity, onset, progression, and its relationship with training. This section is designed to be repeated weekly in pain-free athletes to monitor changes in their condition. If the athlete is already injured or a painful condition is detected in the first tier, he is prompted to proceed to the second tier. Here, the Performance, Participation, Psychological, and Social impacts resulting from the injury are thoroughly investigated. An athlete gets a minimum of 0 and a maximum of 128 points on the injury impact scale. Higher points show worse health conditions.
3 secondary outcomes
Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury (OSTRC-O)
Time frame: Baseline
Oslo Sports Trauma Research Centre questionnaires on Health Problems (OSTRC-H)
Time frame: Baseline
Pain Monitoring and Injury Impact Scale (PAMIIS)
Time frame: one week later
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 2 May 2025.
- Background: PubMed 20710023Maffulli N, Longo UG, Gougoulias N, Caine D, Denaro V. Sport injuries: a review of outcomes. Br Med Bull. 2011;97:47-80. doi: 10.1093/bmb/ldq026. Epub 2010 Aug 14.
- BackgroundMeeuwisse WH. Assessing causation in sport injury: a multifactorial model. LWW; 1994. p. 166-170.
- Background: PubMed 41306359Yilmaz Ozal S, Kafa N, Yuksel F, Guzel N. Turkish translation and validation of the Oslo Sports Trauma Research Center (OSTRC) Questionnaires. Malawi Med J. 2025 Apr 2;37(1):44-50. doi: 10.4314/mmj.v37i1.7. eCollection 2025 Mar.
- Results publicationÖzal Ş, Kafa N, Güzel NA, Development of a measurement tool for investigation of pain monitoring and post-injury effects in athletes, Gazi University Institute of the Health Science PhD thesis 2023/4
- Individual participant dataSharing planned: No
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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.
Şeyda YILMAZ ÖZAL, Assistant Professor principal investigator
Ankara Medipol University
Nihan KARATAŞ, Professor study director
Gazi University
Nevin ATALAY GÜZEL, Professor study chair
Gazi University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Injuries and Social Impact, run by Gazi University at 2 sites 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 1 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 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pain Monitoring and Injury Impact Scale (PAMIIS) (time frame: Baseline). 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 NCT06955364, which also lists 4 linked publications.
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 2 May 2025.