NCT04812158

Video Aided Mindful Deep Breathing for Pain Management

Completed NA Last updated 23 March 2021

What this trial tests

NA trial testing standard ankle physiotherapy or rehabilitation for chronic ankle instability in Musculoskeletal Pain in 45 participants. Completed in 19 February 2019.

Timeline

15 January 2018

Primary endpoint
19 February 2019

19 February 2019

Quick facts

Lead sponsor	Universiti Tunku Abdul Rahman
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	45
Start date	15 January 2018
Primary completion	19 February 2019
Estimated completion	19 February 2019
Sites	1 location across Malaysia

Drugs / interventions tested

• standard ankle physiotherapy or rehabilitation for chronic ankle instability

Conditions studied

• Musculoskeletal Pain — all drugs for Musculoskeletal Pain →
• Ankle Injuries — all drugs for Ankle Injuries →
• Joint Instability — all drugs for Joint Instability →

Sponsor

Universiti Tunku Abdul Rahman

Who can join

Adults 18 to 25, male only, with Musculoskeletal Pain or Ankle Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic ankle instability (CAI) is the most common musculoskeletal injury in sports and the rate of CAI accounts for 85% of ankle injuries. It has been estimated that 23,000 ankle sprains occur each day in the United States, representing approximately 1 sprain per 10,000 people per day and nearly one in five ankle injuries result in chronic symptoms. Numerous researchers applied mindfulness for improving the performance of various sports such as table tennis, shooting, cricket, archery, golf, swimming, and cycling. Since many of the players do not possess effective pain coping skills, they are at risk for lifelong impairment of their emotional, social, and physical functioning. Mindfulness-centered interventions may well serve to mitigate pain-related disability. Training in mindfulness meditation improves anxiety, depression, stress, and cognition. Mindfulness-related health benefits are associated with enhancements in cognitive control, emotion regulation, positive mood, and acceptance, each of which have been associated with pain modulation. Since mindfulness has been proven effective in managing various health disorders and in enhancing sports performance, our study aims to apply the mindfulness approach in rehabilitating the most common sports injury, CAI. The improvement in CAI due to the mindfulness approach will be assessed by the improvement in pain response through the Cumberland ankle instability tool, Functional ankle disability index (FADI), Visual analog scale (VAS), Brief Pain Inventory (BPI), Y-balance test, Mindfulness attention awareness score (MAAS), Oxford Happiness Questionnaire (OHQ) quantitative electroencephalography (Q-EEG). This study finding will be useful in assessing the effectiveness of mindfulness in rehabilitating CAI and identify the correlation of CAI pain response with VAS \& BPI, quantitative electroencephalography - Q-EEG. In this clinical trial, the investigators wish to use noninvasive methods such as quantitative EEG (electroencephalogram) to find the brainwave patterns during the different stages of mindfulness intervention (pre and post). The outcome of this study will eventually lead to the identification of a better assessment method to indicate the pain response for the appropriate physiotherapy management. The application of mindfulness technique in CAI management and the usage of Q- EEG to assess the pain response in chronic ankle injury athletes are the novel approaches of this research study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of six-week short-duration deep breathing on young adults with chronic ankle instability-a pilot randomized control trial.
   Ramalingam V, Cheong SK, Lee PF. · · 2023 · cited 1× · PMID 37968738 · DOI 10.1186/s13102-023-00758-5