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NCT05701618 · ClinicalTrials.gov registry record · NA
Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries
A NA study, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 86
- Enrollment target
NCT05701618: Completed NA study, sponsored by Nationwide Children's Hospital.
NCT05701618 is a NA study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 86 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05701618, a NA study, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 86 participants
- Enrollment target
Study Summary
This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with leg pain. A set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participants. Participants will then complete self-report questionnaires assessing pain, quality of life and functional ability followed by an assessment of physical activity levels assessed with a wearable activity monitor;. Participants will then be randomized into one of two intervention groups (psychologically-informed video education group and a control group). After participants receive their assigned educational intervention, the self-report questionnaires will be re-administered. Participants with leg pain pain will then complete follow-up assessment of their psychological beliefs, pain, quality of life, physical activity levels, and self-reported functional ability through REDcap at 1 week, 4 weeks, 3 months, 6 months, and 1 year.
Primary Outcome
The lower extremity function scale is a 20-item self-report questionnaire used to evaluate functional ability during everyday tasks (0-80). Each item is scored on a 0-4 point scale with higher scores representing greater functional ability. The lower extremity function scale has validity in the adolescent population and has a minimal clinical important difference of 9 points.
Interventions
- OTHER Psychologically Informed Education Video Series
- OTHER Anatomy and biomedical education videos
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2023-01-30 |
| Est. Completion | 2025-06-25 |
| Phase | NA |
What the finished NCT05701618 record still lists
NCT05701618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Psychologically Informed Education Video Series is the first listed.
NCT05701618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05701618 about?
NCT05701618 is a clinical study titled "Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries". This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with leg pain. A set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participants. Participants will...
What is the current status of trial NCT05701618?
This trial is currently completed. It is a NA study. The enrollment target is 86 participants. The study started on 2023-01-30. Estimated completion is 2025-06-25.
What interventions are being tested in trial NCT05701618?
The interventions under investigation include: Psychologically Informed Education Video Series (OTHER), Anatomy and biomedical education videos (OTHER).
Who is sponsoring clinical trial NCT05701618?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05701618's enrollment target sits among peer trials
86 976th of 2000 higher than 1,021 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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