Development Study of Pain Monitoring and Injury Impact Scale

NCT06955364 | Completed

• 1 other identifier: GaziUnivrs
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 2

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.

Conditions

Sports Injuries; Social Impact; Psychological Impact of Injury

Keywords

Pain monitoring; Scale development; Performance; Participation

Outcome Measures

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.

  Baseline

Secondary Outcomes (3)

• Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury (OSTRC-O)

  Baseline

• Oslo Sports Trauma Research Centre questionnaires on Health Problems (OSTRC-H)

  Baseline

• Pain Monitoring and Injury Impact Scale (PAMIIS)

  one week later

Study Arms (4)

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

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or illiteracy

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Ankara Medipol University

Ankara, Çankaya, 006450, Turkey (Türkiye)

Location

Gazi University

Ankara, Çankaya, 006450, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 20710023 BACKGROUND

• Meeuwisse WH. Assessing causation in sport injury: a multifactorial model. LWW; 1994. p. 166-170.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 41306359 BACKGROUND

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Şeyda YILMAZ ÖZAL, Assistant Professor

  Ankara Medipol University

  PRINCIPAL INVESTIGATOR

• Nihan KARATAŞ, Professor

  Gazi University

  STUDY DIRECTOR

• Nevin ATALAY GÜZEL, Professor

  Gazi University

  STUDY CHAIR

• Melek Gülşah ŞAHİN, Professor

  Gazi University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Master of Science degree Physiotherapist)

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 2, 2025
• Study Start: June 8, 2022
• Primary Completion: February 14, 2023
• Study Completion: May 23, 2023
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)