Clinical trial NCT06390072: Project Hypnos: The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprains
Motor Coordination or Function; Developmental Disorder
Keywords: Interoceptive awareness
Heart rate variability
Anxiety
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This basic experimental pilot study involved a randomized cross-over design of two brief interventions with a 1:1 allocation ratio
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Balance test 1
timeFrame: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2
measure: Balance test 2
timeFrame: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2
measure: Heart rate variability
timeFrame: Through the study completion, up to 8 days from baseline assessment. Assessed at pre-intervention and post-intervention for sessions 1 and 2
Secondary outcomes:
measure: Ankle disability measure 1
timeFrame: T0, Baseline/Enrollment
measure: Ankle disability measure 2
timeFrame: T0, Baseline/Enrollment
measure: Interoceptive awareness measure 1
timeFrame: T0, Baseline/Enrollment
measure: Interoceptive awareness measure 2
timeFrame: T0, Baseline/Enrollment
measure: Emotional Distress-Anxiety
timeFrame: T0, Baseline/Enrollment
measure: Kinesiophobia
timeFrame: T0, Baseline/Enrollment
measure: Pain self-efficacy
timeFrame: T0, Baseline/Enrollment
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: Nicholas Karayannis, MPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: