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

April 26, 2024 updated by: Ohio University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ankle disability measure 1
Time Frame: T0, Baseline/Enrollment
Identification of Functional Ankle Instability, used for eligibility screening
T0, Baseline/Enrollment
Ankle disability measure 2
Time Frame: T0, Baseline/Enrollment
Functional Ankle Ability Measure
T0, Baseline/Enrollment
Interoceptive awareness measure 1
Time Frame: T0, Baseline/Enrollment
Mindful Presence - Bodily Awareness
T0, Baseline/Enrollment
Interoceptive awareness measure 2
Time Frame: T0, Baseline/Enrollment
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
T0, Baseline/Enrollment
Emotional Distress-Anxiety
Time Frame: T0, Baseline/Enrollment
PROMIS Emotional Distress-Anxiety item bank
T0, Baseline/Enrollment
Kinesiophobia
Time Frame: T0, Baseline/Enrollment
Tampa Scale of Kinesiophobia (TSK-11)
T0, Baseline/Enrollment
Pain self-efficacy
Time Frame: T0, Baseline/Enrollment
Pain Self-Efficacy Questionnaire (PSEQ-10)
T0, Baseline/Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicholas Karayannis, MPT, PhD, Ohio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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