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Completed

NCT Number: NCT06955364

Development Study of Pain Monitoring and Injury Impact Scale

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.

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Key information

Conditions

Sports Injuries Athletic Injuries Psychological Impact of Injury Social Impact Wounds and Injuries

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Medipol University, Ankara, Çankaya, Turkey (Türkiye)

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    "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

  3. Pain Monitoring and Injury Impact Scale (PAMIIS)

    Time frame: one week later

    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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

A New Measurement Tool for Investigation of Pain Monitoring and Post-Injury Effects in Athletes

Acronym: PAMIIS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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