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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Sprains; Motor Coordination or Function; Developmental Disorder
• Intervention / Treatment: Behavioral: Self-Hypnosis; Behavioral: Ankle Education

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Athens, Ohio, United States, 45701
      • Ohio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-hypnosis; The audio-guided self-hypnosis practice was sourced from the Reveri App (reveri.com), developed by Dr. David Spiegel, and entitled "Hypnosis Prep for Workout"	Behavioral: Self-Hypnosis; Participants listened to an 8-minute audio-guided self-hypnosis related to improving their physical performance; Behavioral: Ankle Education; Participants listened to an 8-minute video on ankle sprain diagnosis, prognosis, and treatment
Active Comparator: Ankle Education; The ankle education video, entitled "Ankle Sprain Rehab Exercises" was sourced from the Physio Tutors YouTube channel	Behavioral: Self-Hypnosis; Participants listened to an 8-minute audio-guided self-hypnosis related to improving their physical performance; Behavioral: Ankle Education; Participants listened to an 8-minute video on ankle sprain diagnosis, prognosis, and treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle disability measure 1	Identification of Functional Ankle Instability, used for eligibility screening	T0, Baseline/Enrollment
Ankle disability measure 2	Functional Ankle Ability Measure	T0, Baseline/Enrollment
Interoceptive awareness measure 1	Mindful Presence - Bodily Awareness	T0, Baseline/Enrollment
Interoceptive awareness measure 2	Multidimensional Assessment of Interoceptive Awareness (MAIA-2)	T0, Baseline/Enrollment
Emotional Distress-Anxiety	PROMIS Emotional Distress-Anxiety item bank	T0, Baseline/Enrollment
Kinesiophobia	Tampa Scale of Kinesiophobia (TSK-11)	T0, Baseline/Enrollment
Pain self-efficacy	Pain Self-Efficacy Questionnaire (PSEQ-10)	T0, Baseline/Enrollment

Collaborators and Investigators

• Sponsor: Ohio University
• Investigators: Principal Investigator: Nicholas Karayannis, MPT, PhD, Ohio University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Heart rate variability; Interoceptive awareness
• Additional Relevant MeSH Terms: Mental Disorders; Wounds and Injuries; Leg Injuries; Neurodevelopmental Disorders; Ankle Injuries; Developmental Disabilities
• Other Study ID Numbers: 23-X-71

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No