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

Ankle Sprains Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06390072
• Other study ID #: 23-X-71
• Status: Completed
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: November 27, 2023

Study information

• Verified date: April 2024
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Developmental Disabilities
• Motor Coordination or Function; Developmental Disorder

Intervention

Behavioral:
• Self-Hypnosis
Participants listened to an 8-minute audio-guided self-hypnosis related to improving their physical performance
• Ankle Education
Participants listened to an 8-minute video on ankle sprain diagnosis, prognosis, and treatment

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

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