AnxietyNCT04704765
Abdominal Breathing Training on Reducing Anxiety
A study testing abdominal breathing training in people with Anxiety, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The research purpose is to investigate the effectiveness of abdominal breathing training on reducing anxiety. This study is an experimental research design. Using a randomized controlled trial approach. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- abdominal breathing training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Apr 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Who are over 20 years old.
- The score of Beck anxiety inventory at lease of 8.
- Agree to participate in the study and have filled out a written consent form.
Who cannot join
- Inpatients.
- COPD patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Abdominal Breathing Training on Reducing Anxiety
The research purpose is to investigate the effectiveness of abdominal breathing training on reducing anxiety. This study is an experimental research design. Using a randomized controlled trial approach. The patients receiving the intervention of abdominal breathing training were in the experimental group, while those who did not receive it were in the control group.
Read the detailed description
The aim of the study is to investigate the effectiveness of the abdominal breathing training on reducing anxiety. Using an experimental randomized controlled trial approach. The experimental group receiving abdominal breathing training, and control group without training. The effectiveness assessment used the Beck anxiety inventory, required to be completed by both the experimental group and control group. This study performed the pre-and-post assessments. This study performed the pre-test before the implementation of abdominal breathing training, and performed the post-test at Week 4 and Week 8 the end of abdominal breathing training. During this period, they received the abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day). When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time).
- Conditions
- Anxiety
- Being tested
- abdominal breathing training
- Keywords
- Abdominal Breathing Training, Anxiety, Effectiveness
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal breathing trainingOther
The abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day). When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time).
| Study group | Role | What they receive |
|---|---|---|
| The effectiveness of receiving abdominal breathing training | Experimental | The patients receiving the intervention of abdominal breathing training were in the experimental group. The experimental group received the abdominal breathing training for a total of 8 weeks. During this period, they received the abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day). When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time). The control group without training. Receives: Other: abdominal breathing training |
| The effectiveness of not receiving abdominal breathing training | No intervention | The control group who did not receive abdominal breathing training. The effectiveness assessment used the Beck anxiety inventory and physiological index (heart beats, breath and blood pressure), required to be completed by the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck anxiety inventory
The total items of Beck anxiety inventory are 21. The score of each item is from 0-3. The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety
Measured: pretest
Beck anxiety inventory
The total items of Beck anxiety inventory are 21. The score of each item is from 0-3. The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety
Measured: post-test at Week 4
Beck anxiety inventory
The total items of Beck anxiety inventory are 21. The score of each item is from 0-3. The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety
Measured: post-test at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start21 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using an experimental randomized controlled trial approach. The experimental group receiving abdominal breathing training, and control group without training. The effectiveness assessment used the Beck anxiety inventory, required to be completed by both the experimental group and control group. This study performed the pre-and-post assessments. This study performed the pre-test before the implementation of abdominal breathing training, and performed the post-test at Week 4 and Week 8 the end of abdominal breathing training.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuan-Yi Huang, National Taipei University of Nursing and Health Sciences
- Investigators
- Xuan-Yi Huang, DNSc, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704765
- Sponsor's protocol ID
- 20200105R
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cahalin LP, Braga M, Matsuo Y, Hernandez ED. Efficacy of diaphragmatic breathing in persons with chronic obstructive pulmonary disease: a review of the literature. J Cardiopulm Rehabil. 2002 Jan-Feb;22(1):7-21. doi: 10.1097/00008483-200201000-00002.
PubMed 11839992Chen YF, Huang XY, Chien CH, Cheng JF. The Effectiveness of Diaphragmatic Breathing Relaxation Training for Reducing Anxiety. Perspect Psychiatr Care. 2017 Oct;53(4):329-336. doi: 10.1111/ppc.12184. Epub 2016 Aug 23.
PubMed 27553981Gosselink RA, Wagenaar RC, Rijswijk H, Sargeant AJ, Decramer ML. Diaphragmatic breathing reduces efficiency of breathing in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1995 Apr;151(4):1136-42. doi: 10.1164/ajrccm.151.4.7697243.
PubMed 7697243Hopper SI, Murray SL, Ferrara LR, Singleton JK. Effectiveness of diaphragmatic breathing for reducing physiological and psychological stress in adults: a quantitative systematic review. JBI Database System Rev Implement Rep. 2019 Sep;17(9):1855-1876. doi: 10.11124/JBISRIR-2017-003848.
PubMed 31436595
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Abdominal Breathing Training on Reducing Anxiety
- ClinicalTrials.gov ID
- NCT04704765
- Acronym / sponsor ID
- 20200105R
- Conditions
- Anxiety
- Keywords
- Abdominal Breathing Training, Anxiety, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research purpose is to investigate the effectiveness of abdominal breathing training on reducing anxiety. This study is an experimental research design. Using a randomized controlled trial approach. The patients receiving the intervention of abdominal breathing training were in the experimental group, while those who did not receive it were in the control group.
Detailed description
The aim of the study is to investigate the effectiveness of the abdominal breathing training on reducing anxiety. Using an experimental randomized controlled trial approach. The experimental group receiving abdominal breathing training, and control group without training. The effectiveness assessment used the Beck anxiety inventory, required to be completed by both the experimental group and control group. This study performed the pre-and-post assessments. This study performed the pre-test before the implementation of abdominal breathing training, and performed the post-test at Week 4 and Week 8 the end of abdominal breathing training. During this period, they received the abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day). When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using an experimental randomized controlled trial approach. The experimental group receiving abdominal breathing training, and control group without training. The effectiveness assessment used the Beck anxiety inventory, required to be completed by both the experimental group and control group. This study performed the pre-and-post assessments. This study performed the pre-test before the implementation of abdominal breathing training, and performed the post-test at Week 4 and Week 8 the end of abdominal breathing training.
| Arm | Type | Receives |
|---|---|---|
| The effectiveness of receiving abdominal breathing training | Experimental | Other: abdominal breathing trainingThe patients receiving the intervention of abdominal breathing training were in the experimental group. The experimental group received the abdominal breathing training for a total of 8 weeks. During this period, they received the abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day). When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time). The control group without training. |
| The effectiveness of not receiving abdominal breathing training | No intervention | –The control group who did not receive abdominal breathing training. The effectiveness assessment used the Beck anxiety inventory and physiological index (heart beats, breath and blood pressure), required to be completed by the control group. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Who are over 20 years old.
- The score of Beck anxiety inventory at lease of 8.
- Agree to participate in the study and have filled out a written consent form.
Key exclusion criteria (2 listed)
- Inpatients.
- COPD patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal breathing trainingThe abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day). When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time). | Other | The effectiveness of receiving abdominal breathing training |
Primary outcome
Beck anxiety inventory
Time frame: pretest
The total items of Beck anxiety inventory are 21. The score of each item is from 0-3. The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety
Beck anxiety inventory
Time frame: post-test at Week 4
The total items of Beck anxiety inventory are 21. The score of each item is from 0-3. The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety
Beck anxiety inventory
Time frame: post-test at Week 8
The total items of Beck anxiety inventory are 21. The score of each item is from 0-3. The score 0-7 is the least mild anxiety, 8-15 is the mild anxiety, 16-25 is the moderate anxiety, and 26-63 is the severe anxiety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Results publication: PubMed 11839992Cahalin LP, Braga M, Matsuo Y, Hernandez ED. Efficacy of diaphragmatic breathing in persons with chronic obstructive pulmonary disease: a review of the literature. J Cardiopulm Rehabil. 2002 Jan-Feb;22(1):7-21. doi: 10.1097/00008483-200201000-00002.
- Results publication: PubMed 27553981Chen YF, Huang XY, Chien CH, Cheng JF. The Effectiveness of Diaphragmatic Breathing Relaxation Training for Reducing Anxiety. Perspect Psychiatr Care. 2017 Oct;53(4):329-336. doi: 10.1111/ppc.12184. Epub 2016 Aug 23.
- Results publication: PubMed 7697243Gosselink RA, Wagenaar RC, Rijswijk H, Sargeant AJ, Decramer ML. Diaphragmatic breathing reduces efficiency of breathing in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1995 Apr;151(4):1136-42. doi: 10.1164/ajrccm.151.4.7697243.
- Results publication: PubMed 31436595Hopper SI, Murray SL, Ferrara LR, Singleton JK. Effectiveness of diaphragmatic breathing for reducing physiological and psychological stress in adults: a quantitative systematic review. JBI Database System Rev Implement Rep. 2019 Sep;17(9):1855-1876. doi: 10.11124/JBISRIR-2017-003848.
- This article reviews the literature regarding the efficacy of DB in persons with chronic obstructive pulmonary disease (COPD), and reports on the beneficial and detrimental effects of DB in persons with COPD.Link provided by the sponsor.
- The findings provide guidance for providing quality care that effectively reduces the anxiety level of care recipients in clinical and community settings.Link provided by the sponsor.
- Tidal volume, respiratory frequency, and duty cycle did not change significantly during diaphragmatic breathing. Dyspnea sensation tended to increase during diaphragmatic breathing.Link provided by the sponsor.
- The evidence suggests that diaphragmatic breathing may decrease stress as measured by physiologic biomarkers, as well psychological self-report tools.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuan-Yi Huang, DNSc principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal breathing training in people with Anxiety, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck anxiety inventory (time frame: pretest). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704765, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.