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Study of Effectiveness of Audio Guided Deep Breathing on Improving the Quality of Life of Physically Disabled Group

Primary Purpose

Psychophysiology, Visually Impaired Persons, Physiological Phenomena

Status
Not yet recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Audio-guided deep breathing
Sponsored by
Universiti Tunku Abdul Rahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychophysiology focused on measuring Guided Deep Breathing, Visual Impairment, Physical Disability, Mental Stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Visual Acuity in the better-seeing eye worse than 6/12, according to the criteria of the World Health Organization (for visually impaired only).
  • hair length of at least 1 cm long
  • have consistent internet and computer/laptop/mobile phone access

Exclusion Criteria:

  • fail to meet the above-listed inclusion criteria
  • those who are unable to take deep breathing for 5 minutes or more
  • having taken or on drug prescription and medication
  • those who with a medical condition for the past two weeks other than visual impairment
  • other long-term diseases or medical condition impacting physical disability
  • those who do smoking

Sites / Locations

  • Tunku Abdul Rahman University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Experimental Group with Audio-guided deep breathing

Arm Description

Participants (healthy or physically disabled) in the control group do not require to perform audio-guided deep breathing for 14 days continuously

Participants (healthy or physically disabled) in the interventional group need to perform 5 mins audio-guided deep breathing with 6 deep breaths per minute for 14 days continuously

Outcomes

Primary Outcome Measures

Change from baseline stress by Perceived Stress Scale (PSS)
PSS is an international instrument that is designed to evaluate the individual's stress level. It requires participants to rate their feeling and thoughts in the past month in the different cases provided. The rating is described as a scale of 0 (never) to 4 (very often). If the summated score is high, it is always associated with a higher level of perceived stress.
Change from baseline quality of life by World Health Organization Quality of Life - BREF (WHO-BREF)
WHO-BREF consists of 26 items that are divided into four domains namely physical health, psychological, social relationships and environment to measure participants' quality of life. The scores follow five-point Likert Scales where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". Higher scores indicate higher quality of life.
Change from baseline mindfulness level by Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
CAMS-R is a ten-item scales designed to measure one's mindfulness approach to relate their feeling, emotion and thought. It is presented in four Likert scales from 1 (Rarely/Not at all) to 4 (Almost always) which require the participant to rate how applicable each item is to them.
Change from baseline Alpha waves by Non-invasive electroencephalogram (EEG)
The 32- channel electrodes were placed in compliance with the International 10-20 System nomenclature. The increase or decrease in Alpha wave EEG recordings of the participants are recorded in eyes closed for 1 min
Change from baseline Beta waves by Non-invasive electroencephalogram (EEG)
The 32- channel electrodes were placed in compliance with the International 10-20 System nomenclature. The increase or decrease in Beta wave EEG recordings of the participants are recorded in eyes closed for 1 min
Change from baseline Theta waves by Non-invasive electroencephalogram (EEG)
The 32- channel electrodes were placed in compliance with the International 10-20 System nomenclature. The increase or decrease in Theta wave EEG recordings of the participants are recorded in eyes closed for 1 min
Change from baseline hair cortisol level by hair cortisol analysis
Hair samples will be collected from the participants. Scissors and hair clips will be used to collect hair samples closed to the scalp surface. Each hair sample will be stored in an envelope and labelled with a unique identification code according to the protocol provided by the laboratory appointed. Hair cortisol will be weighted, disinfected and pulverized into fine hair powder. Extraction methods will be applied to the samples by incubation and extraction solvent. The concentration will be measured using a commercially available ELISA kit
Change from baseline tidal volume by digital spirometer.
An electronic digital spirometer will be used to measure tidal volume. The participant will need to breathe out through a one-way valve disposable mouthpiece attached to the spirometer.
Change from baseline heart rate variability (HRV) by mobile HRV measurement software
A mobile HRV measurement software will be applied to measure the HRV of each participant. HRV Changes will be taken after the intervention for 14 days continuously. Change = (Day 14 - baseline, Day 7 - baseline, progressive changes (Day 1 - 14))
Change from baseline by Rosenberg's Self-Esteem Scale
Rosenberg's Self-esteem scale is a ten-item scale designed to measure one's positive and negative values towards themselves. In other words, it is used to measure individual self-esteem. All answers are in 4-Likert Scales format from 1 (strongly disagree) to 4 (strongly agree). Higher scores indicate higher self-esteem.

Secondary Outcome Measures

Change in Go/no-go task performance assessed by the Auditory Go/no-go task
Performance on go/no-go task as measured by reaction time, omission error, commission error and reaction time variability

Full Information

First Posted
May 24, 2022
Last Updated
June 1, 2022
Sponsor
Universiti Tunku Abdul Rahman
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1. Study Identification

Unique Protocol Identification Number
NCT05396027
Brief Title
Study of Effectiveness of Audio Guided Deep Breathing on Improving the Quality of Life of Physically Disabled Group
Official Title
Study of Effectiveness of Audio Guided Deep Breathing on Improving the Quality of Life of Physically Disabled Group
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Tunku Abdul Rahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Diaphragmatic breathing brings different advantages to improve physical and mental health but it could be difficult for the physically disabled group to follow the practice by themselves especially those with vision impairment. Therefore, guided deep breathing is desirable to address their needs but these are rarely analyzed in the previous literature. This research aims to study the physiological impacts and psychological health of audio-guided deep breathing on physically disabled groups. The psychological changes will be assessed by Perceived Stress Scale (PSS), World Health Organization Quality of Life (WHO-BREF) and Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Besides, physiological parameters such as tidal volume, electroencephalography, hair cortisol level and heart rate variability are measured non-invasively to evaluate the impact of audio-guided deep breathing. Furthermore, auditory Go-No Go Task will be adopted as a neuropsychological test in determining changes in response control and sustained attention in this study as well. Eventually, the pre-and post-interventional data will be analyzed and processed to study the effect of audio-guided deep breathing on these special groups.
Detailed Description
Background: Diaphragmatic breathing is also known as deep breathing as the breathing process is always associated with belly expansion, diaphragm contraction, and deep inhalation and exhalation which results in greater intake of blood gases and reduced respiratory frequency that is in contrast to the normal breathing cycle. Some of the studies revealed the potentiality of deep breathing in enhancing social adaption, emotional balance, stress management and physiological stability. The advantages of deep breathing also have been reported extensively in ancient eastern religions, including yoga, meditation and Tai Chi Chuan (TCC). The positive outcomes of deep breathing have evoked scientific interest in the investigation of the causal relationship between deep breathing practice and physiological behaviours. Since deep breathing is voluntary respiration which is opposed to natural breathing, it will give rise to certain degrees of physiological changes unavoidably. Physiological changes including tidal volume, heart rate variability, electroencephalography and hair cortisol level have been reported in the previous works of literature. Literature Review: Effect of Deep Breathing on Pulmonary Function To achieve optimal oxygen saturation level, tidal volume and respiratory rate are the two primary components of respiratory measurement responsible for the purpose. Tidal volume is the amount of air-filled in each breathing cycle. Under relaxed conditions, these two parameters change interchangeably to optimize oxygen intake. Since deep breathing is involuntary breathing, it inevitably brings changes to the pulmonary parameters. For example, some researchers found out that tidal volume and other pulmonary parameters such as forced expiratory volume and forced vital capacity increased after ten minutes of deep breathing compared to normal chest breathing. Some authors also agreed that the deep breathing technique showed improvement in pulmonary function in a healthy subject. Effect of Deep Breathing on Heart Rate Variability Heart Rate Variability (HRV) is modulated by autonomic nervous system and further divided into two branches: sympathetic and parasympathetic pathways. The sympathetic nervous system is concerned with critical events such as respiratory failure and survival challenges that causes blood pressure and heart rate to increase. This is known as the "fight-or-flight" reaction. In contrast, the parasympathetic nervous system focuses on the resting and conservation of energy that acts in opposition to the sympathetic pathway. They work together dynamically giving rise to HRV and serving as a measurable index of autonomic control. It was reported that breathing can influence cardiopulmonary function that indirectly reflects HRV. Inhalation and exhalation alter the heart rate which is known as respiratory sinus arrhythmia (RSA). In other words, inhalation reduces R-R intervals in electrocardiogram (ECG) and increases during exhalation. Slow and deep breathing which has lower respiratory frequency is found to augment cardiorespiratory synchronization and elevate HRV. Most of the studies reported that slow and deep breathing can bring positive effects to HRV that is associated with stress, diabetes mellitus and rheumatoid arthritis. The analysis of HRV can be divided into time-domain and frequency-domain analyses. In frequency-domain analysis, there are high-frequency spectrum (HF) (0.14 Hz - 0.40 Hz) and low-frequency spectrum (LF) (0.04 Hz - 0.15 Hz) that refer to parasympathetic and sympathetic activities respectively. On the other hand, time-domain analysis, for instance, root mean square of the variation in R-R interval (RMSSD), N-N interval standard deviation (SDNN) and average R-R intervals standard deviation (SDANN) are begin measured as the units. One of the studies suggested that LF increased at once after five minutes of deep breathing whereas SDNN and RMSSD changes are insignificant. Conversely, a pilot study on the impact of different deep breathing duration reported showed that normalized HF power is smaller than the control group without deep breathing. This study suggested that depression score is lower in the deep breathing groups with lower HF reading. The difference is due to the sympathetic activation being involved when a novel and short exercise was provided whereas long training will shift to parasympathetic activation. Another research also suggested that SDNN increased after deep breathing indicating stress relief. Effect of Deep Breathing on Electroencephalography (EEG) Electroencephalography (EEG) is a well-known screening technique to acquire the scalp electrical behaviour of the brain. The electrical activity is a product of neuron activation in the brain that causes a flow of current. During the event of synaptic activation in the cerebral cortex, the current flow is the one captured by EEG. There have been numerous studies to investigate the application of EEG in neurology and neuropsychology studies due to its strong ability in receiving neurofeedback from the brain from the past until now. The brainwave is classified into four mainly by the amplitude and frequency differences. Alpha waves (8 - 13 Hz) is associated with the mental task, awake or resting that is recorded in the parieto-occipital area. Next, beta waves (14 - 30 Hz) is gathered during mental activity similarly which is presented in the parietal or frontal region while theta waves (4 - 7 Hz) is found when an adult is sleeping or drowsy but it also indicates stress when the adult is waked. The last wave is delta waves (< 3.5 Hz) which shows that an adult is in deep sleep or severe brain damage in waked adult. These brainwaves are shown to correlate with deep breathing. Alpha wave is associated with relaxation and stability while beta wave shows certain degrees of stress and stimulation. For example, it was suggested that slow and deep breathing elevated alpha to the high beta ratio which indicates improvement of mental stability. Similarly, deep breathing, as an important element in mediation and yoga practice also has proposed that it increased alpha power in prior studies. On the other hand, some studies showed that beta activity decreased after slow and deep breathing but some studies oppose the findings. Previous research projects have documented that frontal theta power increased is associated with reduced anxiety as well. Effect of Deep Breathing on Cortisol Level In the event of the stress response, a cascade reaction of hormone occurs at the pituitary gland, hypothalamus and adrenal gland. Glucocorticoids is a compound as a result of the stimulation play an important role in stress coping that could activate a series of physiological responses such as immune activation, inflammatory suppression, reproductive physiology reduction and energy mobilization. Hair cortisol analysis is a relatively novel technique compared to saliva and urine cortisol analysis. Although the mechanism of cortisol deposition is pending further investigation, it is a promising technique with more benefits. It is non-invasive, unlikely to be affected by sampling procedures, lower storage requirement and cortisol production measured has a longer timeframe (months to years). Therefore, it is considered a good biomarker of chronic stress level that has driven several studies such as antenatal stress, relaxation interventions, early childhood and neonates. Deep breathing has been shown to reduce cortisol levels which were reported by previous studies. However, they were using saliva and plasma for the assessment respectively. Similarly, some authors have provided evidence of interventions that are incorporated with deep breathing reported to reduce cortisol levels as well. For example, it was suggested that laughter yoga that involved deep breathing as one of the components has shown a reduction in salivary cortisol levels. For hair cortisol assessment, one study used this technique that stress reduction program with deep breathing component proved that cortisol level was reduced. The relationship between hair cortisol and deep breathing intervention is rarely analyzed in the previous studies. A closer look at the literature on intervention incorporated with a deep breathing exercise, however, reveals a question of whether deep breathing alone was contributing to the reduction of hair cortisol. Therefore, this was an important question to study the effect of deep breathing exercise itself on hair cortisol levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychophysiology, Visually Impaired Persons, Physiological Phenomena, Psychological Stress
Keywords
Guided Deep Breathing, Visual Impairment, Physical Disability, Mental Stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The crossover study design is implemented whereby healthy participants are assigned to the control group whereas visually impaired participants are assigned to the intervention group initially. After 14 days, the same participants cross over from the first session to the second session during the experiment.
Masking
Participant
Masking Description
Participants do not know which study group they are in.
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants (healthy or physically disabled) in the control group do not require to perform audio-guided deep breathing for 14 days continuously
Arm Title
Experimental Group with Audio-guided deep breathing
Arm Type
Experimental
Arm Description
Participants (healthy or physically disabled) in the interventional group need to perform 5 mins audio-guided deep breathing with 6 deep breaths per minute for 14 days continuously
Intervention Type
Other
Intervention Name(s)
Audio-guided deep breathing
Intervention Description
2 weeks of audio-guided deep breathing for participants (healthy and physically disabled)
Primary Outcome Measure Information:
Title
Change from baseline stress by Perceived Stress Scale (PSS)
Description
PSS is an international instrument that is designed to evaluate the individual's stress level. It requires participants to rate their feeling and thoughts in the past month in the different cases provided. The rating is described as a scale of 0 (never) to 4 (very often). If the summated score is high, it is always associated with a higher level of perceived stress.
Time Frame
Baseline, 14 days
Title
Change from baseline quality of life by World Health Organization Quality of Life - BREF (WHO-BREF)
Description
WHO-BREF consists of 26 items that are divided into four domains namely physical health, psychological, social relationships and environment to measure participants' quality of life. The scores follow five-point Likert Scales where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". Higher scores indicate higher quality of life.
Time Frame
Baseline, 14 days
Title
Change from baseline mindfulness level by Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Description
CAMS-R is a ten-item scales designed to measure one's mindfulness approach to relate their feeling, emotion and thought. It is presented in four Likert scales from 1 (Rarely/Not at all) to 4 (Almost always) which require the participant to rate how applicable each item is to them.
Time Frame
Baseline, 14 days
Title
Change from baseline Alpha waves by Non-invasive electroencephalogram (EEG)
Description
The 32- channel electrodes were placed in compliance with the International 10-20 System nomenclature. The increase or decrease in Alpha wave EEG recordings of the participants are recorded in eyes closed for 1 min
Time Frame
Baseline, 7 days, 14 days
Title
Change from baseline Beta waves by Non-invasive electroencephalogram (EEG)
Description
The 32- channel electrodes were placed in compliance with the International 10-20 System nomenclature. The increase or decrease in Beta wave EEG recordings of the participants are recorded in eyes closed for 1 min
Time Frame
Baseline, 7 days, 14 days
Title
Change from baseline Theta waves by Non-invasive electroencephalogram (EEG)
Description
The 32- channel electrodes were placed in compliance with the International 10-20 System nomenclature. The increase or decrease in Theta wave EEG recordings of the participants are recorded in eyes closed for 1 min
Time Frame
Baseline, 7 days, 14 days
Title
Change from baseline hair cortisol level by hair cortisol analysis
Description
Hair samples will be collected from the participants. Scissors and hair clips will be used to collect hair samples closed to the scalp surface. Each hair sample will be stored in an envelope and labelled with a unique identification code according to the protocol provided by the laboratory appointed. Hair cortisol will be weighted, disinfected and pulverized into fine hair powder. Extraction methods will be applied to the samples by incubation and extraction solvent. The concentration will be measured using a commercially available ELISA kit
Time Frame
Baseline, 14 days
Title
Change from baseline tidal volume by digital spirometer.
Description
An electronic digital spirometer will be used to measure tidal volume. The participant will need to breathe out through a one-way valve disposable mouthpiece attached to the spirometer.
Time Frame
Baseline, 7 days, 14 days
Title
Change from baseline heart rate variability (HRV) by mobile HRV measurement software
Description
A mobile HRV measurement software will be applied to measure the HRV of each participant. HRV Changes will be taken after the intervention for 14 days continuously. Change = (Day 14 - baseline, Day 7 - baseline, progressive changes (Day 1 - 14))
Time Frame
Baseline, Day 1 to day 14
Title
Change from baseline by Rosenberg's Self-Esteem Scale
Description
Rosenberg's Self-esteem scale is a ten-item scale designed to measure one's positive and negative values towards themselves. In other words, it is used to measure individual self-esteem. All answers are in 4-Likert Scales format from 1 (strongly disagree) to 4 (strongly agree). Higher scores indicate higher self-esteem.
Time Frame
Baseline, 14 days
Secondary Outcome Measure Information:
Title
Change in Go/no-go task performance assessed by the Auditory Go/no-go task
Description
Performance on go/no-go task as measured by reaction time, omission error, commission error and reaction time variability
Time Frame
Baseline, 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Visual Acuity in the better-seeing eye worse than 6/12, according to the criteria of the World Health Organization (for visually impaired only). hair length of at least 1 cm long have consistent internet and computer/laptop/mobile phone access Exclusion Criteria: fail to meet the above-listed inclusion criteria those who are unable to take deep breathing for 5 minutes or more having taken or on drug prescription and medication those who with a medical condition for the past two weeks other than visual impairment other long-term diseases or medical condition impacting physical disability those who do smoking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Poh Foong Lee, PhD
Phone
+60390860288
Email
leepf@utar.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Keng Cheong, MBBS,MRCP
Email
cheongsk@utar.edu.my
Facility Information:
Facility Name
Tunku Abdul Rahman University
City
Cheras
State/Province
Kajang, Selangor
ZIP/Postal Code
43000
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Poh Foong Lee, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Based on informed consent, participants data not shared

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Study of Effectiveness of Audio Guided Deep Breathing on Improving the Quality of Life of Physically Disabled Group

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