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CompletedNCT06955364PAMIISUpdated May 2, 2025

Development Study of Pain Monitoring and Injury Impact Scale

An observational study in Sports Injuries, Social Impact and Psychological Impact of Injury, sponsored by Gazi University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Gazi University · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
268
Ages
13 Years and older
Sex
All
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Study 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, 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).

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Conditions studied

  • Sports Injuries
  • Social Impact
  • Psychological Impact of Injury

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Keywords

  • Pain monitoring
  • Scale development
  • Performance
  • Participation
03

In context

Athletic Injuries

273 studies on the registry are indexed under Athletic Injuries; 43 are open to participants now.

This study's enrollment of 268 is above the median of 100 across 103 observational studies indexed under Athletic Injuries.

Browse Athletic Injuries studies →

Lead sponsor

Gazi University is the lead sponsor of 548 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All athletes who regularly participate in a sporting activity for more than six months, aged 13 or over, and Turkish-speaking.

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

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or illiteracy
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
268 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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

    Time frame: Baseline

  3. 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.

    Time frame: one week later

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Study locations

2 sites
  • Ankara Medipol University
    Ankara, Çankaya 006450, Turkey (Türkiye)
  • Gazi University
    Ankara, Çankaya 006450, Turkey (Türkiye)
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References and documents

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 20710023 ↗
  • Meeuwisse 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 41306359 ↗
  • Özal 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 data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in Feb 2023, 8 months.

Of 40 non-industry observational studies under Athletic Injuries, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 8 months is above that.

Counting every sponsor, half of 40 studies reached it within 7 months; a quarter within 2 and three quarters within 11.

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

Registered
Apr 21, 2025
First posted
May 2, 2025
StartActual
Jun 8, 2022
Primary completionActual
Feb 14, 2023
CompletionActual
May 23, 2023
Last update
May 2, 2025
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 May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06955364
Lead sponsor
Gazi University
Responsible party
Şeyda ÖZAL (Principal Investigator (Master of Science degree Physiotherapist), Gazi University) — Principal investigator
First posted
May 2, 2025
Start date
Jun 8, 2022
Primary completion
Feb 14, 2023
Completion
May 23, 2023
Last update
May 2, 2025

Study contacts

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
Melek Gülşah ŞAHİN, Professor
study chair · Gazi University

Oversight

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

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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