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临床试验/NCT05396027
NCT05396027Unknown不适用

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

Universiti Tunku Abdul Rahman2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Change from baseline tidal volume by digital spirometer.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Participants do not know which study group they are in.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change from baseline tidal volume by digital spirometer.

时间窗: Baseline, 7 days, 14 days

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 Beta waves by Non-invasive electroencephalogram (EEG)

时间窗: Baseline, 7 days, 14 days

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 mindfulness level by Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

时间窗: Baseline, 14 days

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 Theta waves by Non-invasive electroencephalogram (EEG)

时间窗: Baseline, 7 days, 14 days

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 heart rate variability (HRV) by mobile HRV measurement software

时间窗: Baseline, Day 1 to day 14

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 stress by Perceived Stress Scale (PSS)

时间窗: Baseline, 14 days

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)

时间窗: Baseline, 14 days

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 Alpha waves by Non-invasive electroencephalogram (EEG)

时间窗: Baseline, 7 days, 14 days

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 by Rosenberg's Self-Esteem Scale

时间窗: Baseline, 14 days

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.

Change from baseline hair cortisol level by hair cortisol analysis

时间窗: Baseline, 14 days

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

次要结局

  • Change in Go/no-go task performance assessed by the Auditory Go/no-go task(Baseline, 14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Poh Foong Lee, PhD

Assistant Professor

Universiti Tunku Abdul Rahman

研究点 (2)

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