Clinical trial NCT06955364: Development Study of Pain Monitoring and Injury Impact Scale
Official title: A New Measurement Tool for Investigation of Pain Monitoring and Post-Injury Effects in Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sports Injuries
Social Impact
Psychological Impact of Injury
Keywords: Pain monitoring
Scale development
Performance
Participation
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 268
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

Brief 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.

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).

Eligibility criteria: 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:

* Pregnancy or illiteracy

Primary outcomes:
measure: Pain Monitoring and Injury Impact Scale (PAMIIS)
timeFrame: Baseline
Secondary outcomes:
measure: Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury (OSTRC-O)
timeFrame: Baseline
measure: Oslo Sports Trauma Research Centre questionnaires on Health Problems (OSTRC-H)
timeFrame: Baseline
measure: Pain Monitoring and Injury Impact Scale (PAMIIS)
timeFrame: one week later
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Medipol University
state: Çankaya
city: Ankara
country: Turkey
facility: Gazi University
state: Çankaya
Study officials:
affiliation: Ankara Medipol University
name: Şeyda YILMAZ ÖZAL, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Nihan KARATAŞ, Professor
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Nevin ATALAY GÜZEL, Professor
role: STUDY_CHAIR
affiliation: Gazi University
name: Melek Gülşah ŞAHİN, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: Meeuwisse WH. Assessing causation in sport injury: a multifactorial model. LWW; 1994. p. 166-170.
citation: 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
citation: Seyda, Y. O., Nihan, K., Fuat, Y., & Nevin, G. (2025). Turkısh translatıon and valıdatıon of the Oslo Sports Trauma Research Center (OSTRC) Questıonnaıres. Malawi Medical Journal, 37(1), 44-50.