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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06390072
Enrollment
24
Registered
2024-04-29
Start date
2023-09-25
Completion date
2023-11-27
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains, Motor Coordination or Function; Developmental Disorder

Keywords

Interoceptive awareness, Heart rate variability, Anxiety

Brief summary

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.

Interventions

BEHAVIORALSelf-Hypnosis

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

BEHAVIORALAnkle Education

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

Sponsors

Ohio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This basic experimental pilot study involved a randomized cross-over design of two brief interventions with a 1:1 allocation ratio

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Balance test 1Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2Biodex Stability System
Balance test 2Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2Y-Balance test
Heart rate variabilityThrough the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2HRV was captured for 5 minutes using a three-lead electrocardiogram at the beginning of each of the two lab sessions

Secondary

MeasureTime frameDescription
Interoceptive awareness measure 2T0, Baseline/EnrollmentMultidimensional Assessment of Interoceptive Awareness (MAIA-2)
Emotional Distress-AnxietyT0, Baseline/EnrollmentPROMIS Emotional Distress-Anxiety item bank
Ankle disability measure 1T0, Baseline/EnrollmentIdentification of Functional Ankle Instability, used for eligibility screening
Pain self-efficacyT0, Baseline/EnrollmentPain Self-Efficacy Questionnaire (PSEQ-10)
KinesiophobiaT0, Baseline/EnrollmentTampa Scale of Kinesiophobia (TSK-11)
Ankle disability measure 2T0, Baseline/EnrollmentFunctional Ankle Ability Measure
Interoceptive awareness measure 1T0, Baseline/EnrollmentMindful Presence - Bodily Awareness

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026