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

NCT05396027 | Unknown

• 1 other identifier: IPSR/RMC/UTARRF/2020-C2/L05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychophysiology; Visually Impaired Persons; Physiological Phenomena; Psychological Stress

Keywords

Guided Deep Breathing; Visual Impairment; Physical Disability; Mental Stress

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Change in Go/no-go task performance assessed by the Auditory Go/no-go task

  Baseline, 14 days

Study Arms (2)

Control Group

NO INTERVENTION

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

Experimental Group with Audio-guided deep breathing

EXPERIMENTAL

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

Other: Audio-guided deep breathing

Interventions

Audio-guided deep breathing OTHER

2 weeks of audio-guided deep breathing for participants (healthy and physically disabled)

Experimental Group with Audio-guided deep breathing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (1)

Tunku Abdul Rahman University

Cheras, Kajang, Selangor, 43000, Malaysia

Location

MeSH Terms

Conditions

Stress, Psychological; Vision Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Poh Foong Lee, PhD

CONTACT

+60390860288; leepf@utar.edu.my

Soo Keng Cheong, MBBS,MRCP

CONTACT

cheongsk@utar.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not know which study group they are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)