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Completed

NCT Number: NCT06390072

Project Hypnos: The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability

This study will determine the relationship of one's self-reported awareness of their body and their ankle motor control for people with chronic ankle instability. This study will further identify the correlates between certain psychological characteristics (i.e., fear and anxiety) and autonomic nervous system arousal (i.e., heart rate variability). Furthermore, this study will elucidate the potential impact of a brief hypnosis practice on balance performance.

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Key information

Conditions

Ankle Sprains Ankle Injuries Anxiety Disorders Developmental Disabilities Leg Injuries Mental Disorders Motor Coordination or Function; Developmental Disorder Neurodevelopmental Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • History of one significant ankle sprain
  • Experiences of instability in the ankle, determined by a score of > 11 on the Identification of Functional Ankle Instability (IdFAI) questionnaire
  • An overall sensation of disability, determined by a score of < 90% on the Functional Ankle Ability Measure (FAAM) questionnaire

Exclusion criteria

  • If the participant's initial ankle sprain was within the past twelve months or the most recent ankle sprain was within the past three months, the participant was excluded from eligibility
  • A history of lower extremity surgery
  • A fracture to the lower extremity
  • Any acute musculoskeletal injuries to lower extremities in the past three months

Treatment and study plan

Self-hypnosis

Behavioral

Participants listened to an 8-minute audio-guided self-hypnosis related to improving their physical performance

Ankle Education

Behavioral

Participants listened to an 8-minute video on ankle sprain diagnosis, prognosis, and treatment

Primary outcomes

  1. Balance test 1

    Time frame: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2

    Biodex Stability System

  2. Balance test 2

    Time frame: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2

    Y-Balance test

  3. Heart rate variability

    Time frame: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2

    HRV was captured for 5 minutes using a three-lead electrocardiogram at the beginning of each of the two lab sessions

Secondary outcomes

  1. Ankle disability measure 1

    Time frame: T0, Baseline/Enrollment

    Identification of Functional Ankle Instability, used for eligibility screening

  2. Ankle disability measure 2

    Time frame: T0, Baseline/Enrollment

    Functional Ankle Ability Measure

  3. Interoceptive awareness measure 1

    Time frame: T0, Baseline/Enrollment

    Mindful Presence - Bodily Awareness

  4. Interoceptive awareness measure 2

    Time frame: T0, Baseline/Enrollment

    Multidimensional Assessment of Interoceptive Awareness (MAIA-2)

  5. Emotional Distress-Anxiety

    Time frame: T0, Baseline/Enrollment

    PROMIS Emotional Distress-Anxiety item bank

  6. Kinesiophobia

    Time frame: T0, Baseline/Enrollment

    Tampa Scale of Kinesiophobia (TSK-11)

  7. Pain self-efficacy

    Time frame: T0, Baseline/Enrollment

    Pain Self-Efficacy Questionnaire (PSEQ-10)

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Registry information

Official study title

The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability: Enhancing and Limiting Psychological Factors, Perceived and Performance-based Ankle Stability, and Heart-rate Variability

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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