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

NCT06390072 | Completed

• 1 other identifier: 23-X-71
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprains; Motor Coordination or Function; Developmental Disorder

Keywords

Interoceptive awareness; Heart rate variability; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Ankle disability measure 1

  T0, Baseline/Enrollment

• Ankle disability measure 2

  T0, Baseline/Enrollment

• Interoceptive awareness measure 1

  T0, Baseline/Enrollment

• Interoceptive awareness measure 2

  T0, Baseline/Enrollment

• Emotional Distress-Anxiety

  T0, Baseline/Enrollment

Study Arms (2)

Self-hypnosis

EXPERIMENTAL

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; Behavioral: Ankle Education

Ankle Education

ACTIVE COMPARATOR

The ankle education video, entitled "Ankle Sprain Rehab Exercises" was sourced from the Physio Tutors YouTube channel

Behavioral: Self-Hypnosis; Behavioral: Ankle Education

Interventions

Self-Hypnosis BEHAVIORAL

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

Ankle Education; Self-hypnosis

Ankle Education BEHAVIORAL

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

Ankle Education; Self-hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Ankle Injuries; Developmental Disabilities; Anxiety Disorders

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nicholas Karayannis, MPT, PhD

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 29, 2024
• Study Start: September 25, 2023
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

US (1)