Video Aided Mindful Deep Breathing for Pain Management

NCT04812158 | Completed

• 3 other identifiers: VAMDB01INTI-FHLS-04-01-2016EMOTIV, 6251/L29
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Musculoskeletal Pain; Ankle Injuries; Joint Instability

Keywords

Mindfulness; Breathing; Rehabilitation; Athletes; Physiotherapy; Electroencephalography

Outcome Measures

Primary Outcomes (7)

• Change from baseline ankle stability by Cumberland Ankle Instability Tool (CAIT), 9-item scores at week 3, week 6 and week 12

  Cumberland Ankle Instability Tool (CAIT), is a reliable and valid tool to assess the balance of participants with ≤27 in the CAIT tool over 30, where lower scores represent "poor" ankle stability and higher scores represent "better" ankle stability. Change =(Week 3 score - Baseline, Week 6 score - Baseline, Week 12 score - Baseline)

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

• Change from baseline dynamic ankle stability by Y-balance test (YBT) scores at week 3, week 6 and week 12

  Y balance test (YBT) is a valid and reliable tool to measure participants' dynamic balance of affected ankle distance in anterior, posterolateral, and posteromedial directions, where lower scores represent "poor" ankle stability and higher scores represent "better" ankle stability. Change =(Week 3 score - Baseline, Week 6 score - Baseline, Week 12 score - Baseline)

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

• Change from baseline in pain by visual analog scale (VAS) at week 3, week 6 and week 12

  A visual analog scale (VAS) is a valid and reliable self-reported tool to record participants' pain intensity on a 10 cm line to point out the pain level. The point at 0 cm represents "no pain" and 10 cm represents "worst pain", where higher scores represent better ankle stability. Change =(Week 3 score - Baseline, Week 6 score - Baseline, Week 12 score - Baseline)

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

• Change from baseline in pain by Brief Pain Inventory (BPI) at week 3, week 6 and week 12

  Brief Pain Inventory (BPI) is a valid and reliable tool to record participants pain intensity and interference with the 4- items (worst pain, least pain, average pain, and pain right now) to measure the pain intensity, and 7 -items (general activity, mood, walking, normal work, relations, sleep, enjoyment of life) to assess the pain interference. The participants are instructed to report the pain intensity from 0 (no pain) to 10 (as pain bad as the participants can imagine). Similarly, the pain interference is recorded from 0 (does not interfere) to 10 (completely interferes). Change =(Week 3 score - Baseline, Week 6 score - Baseline, Week 12 score - Baseline)

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

• Change from baseline ankle stability by Functional ankle disability index (FADI ), 34-item scores at week 3, week 6 and week 12

  Functional ankle disability index (FADI) is a validated tool to assess participant's balance during general daily activity and sports-specific functions, where lower scores represent "poor" ankle stability and higher scores represent "better" ankle stability. Change =(Week 3 score - Baseline, Week 6 score - Baseline, Week 12 score - Baseline)

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

• Change from baseline attention by Mindful Attention Awareness Scale (MAAS), 15-item scores at week 3, week 6 and week 12

  The changes in the mind adaptation of participants are obtained from the Likert scale rating from 1(almost always) to 6 (almost never), MAAS is a reliable tool. Change =(Week 3 score - Baseline, Week 6 score - Baseline, Week 12 score - Baseline)

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

• Change from baseline attention by Oxford Happiness Questionnaire (OHQ), 29-item scores at week 3, week 6 and week 12

  The participants' happiness level is assessed using the reliable tool Oxford Happiness Questionnaire (OHQ), which consists of a 29-item questionnaire. The OHQ score will be recorded on 6 points Likert scale from 1 (strongly disagree) to 6 (strongly agree). Change =(Week 3 score - Baseline, Week 6 score - Baseline, Week 12 score - Baseline)

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

Secondary Outcomes (5)

• Change from baseline Alpha waves by Non-invasive wireless electroencephalogram (EEG) at week 3, week 6, and week 12

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

• Change from baseline Beta waves by Non-invasive wireless electroencephalogram (EEG) at week 3, week 6, and week 12

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

• Change from baseline Theta waves by Non-invasive wireless electroencephalogram (EEG) at week 3, week 6, and week 12

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

• Change from baseline delta waves by Non-invasive wireless electroencephalogram (EEG) at week 3, week 6, and week 12

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

• Change from baseline gamma waves by Non-invasive wireless electroencephalogram (EEG) at week 3, week 6, and week 12

  Baseline, 3 Weeks,6 Weeks, 12 Weeks

Study Arms (3)

Control group

ACTIVE COMPARATOR

participants in the control group receive gold standard physiotherapy intervention 5 times a week for 6 weeks

Other: standard ankle physiotherapy or rehabilitation for chronic ankle instability

Experimental group

EXPERIMENTAL

3 min video-aided mindful deep breathing (VAMDB) or visual guiding on deep breathing with 6 deep breath per minute along with standard physiotherapy (SP) protocol and the control group was given standard physiotherapy (SP) protocol 5 times a week for 6 weeks

Other: standard ankle physiotherapy or rehabilitation for chronic ankle instability

Healthy control

NO INTERVENTION

Active healthy participants who engaged in regular collegial sports

Interventions

standard ankle physiotherapy or rehabilitation for chronic ankle instability OTHER

6 weeks of combined interventions of video aided mindful deep breathing and standard ankle physiotherapy in rehabilitating the chronic ankle instability for participants with chronic ankle instability

Also known as: Video aided mindful deep breathing with standard ankle physiotherapy or rehabilitation for chronic ankle instability

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: The brain signals response differs between the genders and the relative power of beta and theta waves found to be dominant in males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• CAIT scores ≤27
• age ranging from 18 to 25
• male participants
• previous history of ankle sprains
• referred chronic ankle instability for physiotherapy

You may not qualify if:

• history of previous surgery
• under pain-relieving medicine
• under deep breathing or meditation
• bilateral ankle sprains
• acute musculoskeletal injuries of lower limb

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (1)

INTI physiotherapy centre, Nilai

Seremban, Negeri Sembilan, 71800, Malaysia

Location

Related Publications (1)

• Ramalingam V, Cheong SK, Lee PF. Effect of six-week short-duration deep breathing on young adults with chronic ankle instability-a pilot randomized control trial. BMC Sports Sci Med Rehabil. 2023 Nov 15;15(1):155. doi: 10.1186/s13102-023-00758-5.

  PMID: 37968738 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain; Ankle Injuries; Joint Instability; Respiratory Aspiration

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leg Injuries; Wounds and Injuries; Joint Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 23, 2021
• Study Start: January 15, 2018
• Primary Completion: February 19, 2019
• Study Completion: February 19, 2019
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)