Psychological Stress Clinical Trial
Official title:
Study of Effectiveness of Audio Guided Deep Breathing on Improving the Quality of Life of Physically Disabled Group
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | September 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | Tunku Abdul Rahman University | Cheras | Kajang, Selangor |
Lead Sponsor | Collaborator |
---|---|
Universiti Tunku Abdul Rahman |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 14 days | |
Primary | 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. | Baseline, 14 days | |
Primary | 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. | Baseline, 14 days | |
Primary | 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 | Baseline, 7 days, 14 days | |
Primary | 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 | Baseline, 7 days, 14 days | |
Primary | 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 | Baseline, 7 days, 14 days | |
Primary | 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 | Baseline, 14 days | |
Primary | 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. | Baseline, 7 days, 14 days | |
Primary | 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)) |
Baseline, Day 1 to day 14 | |
Primary | 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. | Baseline, 14 days | |
Secondary | 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 | Baseline, 14 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Completed |
NCT05703087 -
Positive Cueing in Knee Arthroplasty.
|
N/A | |
Completed |
NCT02629016 -
Stress Reduction: A Pilot Study With Adolescents
|
N/A | |
Completed |
NCT02541240 -
Effects of an Intervention to Enhance Resilience in Physical Therapy Students
|
N/A | |
Completed |
NCT01406028 -
Does Emotional Support Decrease In Vitro Fertilization Stress?
|
N/A | |
Completed |
NCT00121160 -
Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
|
Phase 1 | |
Completed |
NCT02621775 -
Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA)
|
N/A | |
Recruiting |
NCT04474418 -
Psychometric Characterization of Patients With Cardiac Arrhythmias
|
||
Completed |
NCT03310112 -
Mindfulness Training in U.S. Army Cohorts
|
N/A | |
Terminated |
NCT03893617 -
Brief Stresses Experimental Study
|
Phase 1 | |
Active, not recruiting |
NCT05542498 -
Promoting Stress Management and Engagement in Introductory Physics Courses With Mindfulness and Relaxation
|
N/A | |
Completed |
NCT02394899 -
Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease
|
N/A | |
Terminated |
NCT00962273 -
The Pandemic Stress Vaccine: A Resource to Enhance the Resilience of Healthcare Workers Facing an Infectious Outbreak
|
N/A | |
Completed |
NCT00451126 -
Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol Response to a TSST
|
N/A | |
Completed |
NCT06051500 -
Psychological and Physiological Effects of Different Objects of Breath Meditation
|
N/A | |
Completed |
NCT02801045 -
Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient
|
N/A | |
Completed |
NCT03308344 -
Mindfulness Training in Military Spouses
|
N/A | |
Recruiting |
NCT06029348 -
Cerebrovascular Health and Resilience in Midlife
|
N/A | |
Completed |
NCT04484649 -
Sleeping Healthy/Living Healthy Development
|
N/A | |
Completed |
NCT05869006 -
The Effect of Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice on Psychological Well-Being and Creativity
|
N/A |