Postoperative ComplicationsNCT05492929
The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques on Anxiety and Quality of Life
A study testing The deep breathing group and 4-7-8 breathing technique in people with Postoperative Complications, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study aims to determine the effects of the deep breathing exercise and the 4-7-8 breathing technique applied to patients after bariatric surgery on their anxiety and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- The deep breathing group and 4-7-8 breathing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 5 Jul 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older - 65 years or younger
- Being on the 1st postoperative day
- Have had bariatric surgery
- No communication barrier
- Have an ASA Score I or II
Who cannot join
- Presence of major depression or psychosis
- Having a communication barrier
- Being transferred to another unit
- Leaving work voluntarily
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life
Aim: This study aims to determine the effects of the deep breathing exercise and the 4-7-8 breathing technique applied to patients after bariatric surgery on their anxiety and quality of life.
Materials and Methods: The study was conducted between January and June 2022 at Ankara Lokman Hekim Akay Hospital Endocrinology and Metabolic Diseases Clinic. The research was carried out using the pre-test post-test randomized controlled experimental research design with a control group. A total of 90 patients (30 patients in the deep breathing group, 30 patients in the 4-7-8 breathing group, and 30 patients in the control group) who met the research inclusion criteria were included in the study. While routine care was applied to the control group, 1 group was given deep breathing training, and the other group was given 4-7-8 breathing training. Personal Information Form, the Obesity-Specific Quality of Life Questionnaire, Status, and the State-Trait Anxiety Inventory were used for data collection. In the evaluation of the data, number, percentage, mean, standard deviation, Kolmogorov Smirnov test, chi- square, dependent samples t-test, ANOVA, Tukey's test, Pearson Correlation analysis, and Cronbach's alpha Reliability Coefficient were used.
Read the detailed description
Obesity is a disease whose prevalence is increasing all over the world, reducing the quality and duration of life. Obesity affects the quality of life in all areas, including physiological, psychological, social and environmental aspects. Obesity causes anxiety, depression, low self-esteem and low body image in individuals. Obesity Bariatric surgery is considered to be the most effective and permanent method for weight loss in the treatment of cancer.
In the first month after bariatric surgery, unexpected conditions such as bleeding, thromboembolism, anastomotic leakage, and atelectasis may develop. In obese individuals, lung compliance decreases due to increased pulmonary blood volume and collapse in the peripheral airways. At the same time, excess adipose tissue accumulated in the chest wall and abdomen compresses the thorax and diaphragm, reducing lung volume. Positioning to relieve breathing, in-bed rotation movements, deep breathing and coughing exercises are the most important parts of nursing care, and interventions to prevent pulmonary complications in the postoperative period.
Anxiety is the whole of the natural reactions developed by the body and mind in the face of a situation or stimulus that disturbs the individual and endanger the existence. In everyday language, anxiety is expressed as anxiety and distress.
Gariepy et al. In a review by, it was seen that there is a positive relationship between obesity and anxiety disorders in general. Studies have shown that patients who are suitable for bariatric surgery among obese individuals have high levels of anxiety and depression, and generally have psychiatric disorders.
Anxiety seriously affects the quality of life negatively. The general picture that emerged in a study shows that anxiety impairs quality of life and social functionality in many areas of life. Brown and Roose found that anxiety and depression negatively affect quality of life psychologically and socially. In a study conducted by Çivi et al., when the mean quality of life scores and depression levels were compared, the mean quality of life scores of individuals with depression were found to be significantly lower than those without depression. In the study of Voelkerin and in the systematic review of Kolotkin and Andersen, it was stated that obesity reduces the quality of life. It is necessary to reduce the symptoms of depression and anxiety, to lose weight in a healthy way and to increase the quality of life.
In a study conducted by Ergen, it is recommended that respiratory exercises be routinely applied for the management of anxiety in the postoperative period. In a study by Yekta on mastectomy candidates, rhythmic breathing was found to be effective in reducing anxiety. Yusuf et al. In a study conducted by, it was determined that deep breathing exercise after surgery is an effective, inexpensive, easy and safe method in reducing the level of anxiety.
Holding the breath for a while allows the body to renew its oxygen. The 4-7-8 breathing technique provides the needed oxygen support to organs and tissues and helps to expel CO2. In the 4-7-8 breathing technique, inhale for 4 seconds, hold the breath for 7 seconds and exhale for 8 seconds. Such practices reduce anxiety by both distracting and providing relaxation by oxygenating and expelling the CO2 accumulated in the body.30 There is only one study on the 4-7-8 breathing technique. In the study of Pandekar et al., it was seen that the 4-7-8 breathing technique was effective in reducing anxiety and depression in moderate COPD patients.
It is the nurse's responsibility to provide a comfortable environment for the patient and to increase the quality of life standards. In addition, many studies show that the rate of use of non-pharmacological methods, which are the responsibility of nurses, is low. In this study, we predict that non-pharmacological deep breathing exercises and 4-7-8 breathing techniques will help reduce anxiety and increase the quality of life of patients undergoing bariatric surgery. It is the first study on the subject. This study was carried out to determine the effect of deep breathing exercise and 4-7-8 breathing technique on anxiety level and quality of life after bariatric surgery.
- Conditions
- Postoperative Complications
- Being tested
- The deep breathing group, 4-7-8 breathing technique
- Keywords
- 4-7-8 breathing technique, anxiety, bariatric surgery, deep breathing exercise, quality of life
- Medical subject headings
- Postoperative Complications, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The deep breathing groupOther
The deep breathing group
4-7-8 breathing techniqueOther
4-7-8 breathing technique Group
| Study group | Role | What they receive |
|---|---|---|
| The deep breathing group | Experimental | The deep breathing group was administered the nightly state and trait anxiety scale and SAAQ before the operation, and then they were informed about the deep breathing exercise. Between the 1st and 6th hours of the postoperative period, deep breathing exercise was performed, with 10 breaths per hour. At the end of the 6th hour, the state anxiety scale and SSWS were administered. Receives: Other: The deep breathing group |
| 4-7-8 breathing technique Group | Experimental | The nightly state and trait anxiety scale and the PSSQ were applied to the 4-7-8 breathing group before the operation, and then they were given information about the 4-7-8 breathing technique. Between the 1st and 6th hours postoperatively, the 4-7-8 breathing technique was applied for 1 set (4 breaths) every hour. At the end of the 6th hour, the state anxiety scale and SSWS were administered. Receives: Other: 4-7-8 breathing technique |
| control group | No intervention | In the control group, the nightly state and trait anxiety scale and PSSQ were applied before the operation. At the end of the 6th hour postoperatively, without any application, the state anxiety scale and PSSQ were applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State and Trait Anxiety Inventory
The state anxiety scale requires the person to answer at a certain moment and under certain conditions, while the trait anxiety scale requires the person to answer according to how he or she usually feels.
This scale, which is a self-evaluation scale, consists of state anxiety and trait anxiety sections. It consists of a total of 40 questions, 20-20 in both. This scale is likert type and is graded as 'not at all-somewhat-very-completely'. The points that can be obtained from this inventory are minimum 20 and maximum 80 points.
The scores obtained from the scale are interpreted as increasing the level of anxiety as it approaches 80, and the low level of anxiety as it approaches 20. It is interpreted in the same way when sorting by percentile.
Measured: Change from State and Trait Anxiety Inventory at 24 hours
Obese-Specific Quality of Life Scale
This scale is a 17-item Likert-type scale scored between 0-6. According to the numerical increase order, it is expressed as 'Not at all, Hardly at all, Little, Moderate, Quite, A lot, Extremely'. The scale has no sub-dimensions. The scores obtained from all items of the scale are added together and 17 is subtracted from the obtained score. This score is divided by 102 and multiplied by 100. It is interpreted as the higher the score, the higher the quality of life, and the lower the score, the lower the quality of life.
Measured: Change from Quality of Life at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Jan 2022
- Primary completion1 Apr 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vesile Eskici Ilgin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492929
- Sponsor's protocol ID
- vesile18
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8.
PubMed 36480101
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life
- ClinicalTrials.gov ID
- NCT05492929
- Acronym / sponsor ID
- vesile18
- Conditions
- Postoperative Complications
- Keywords
- 4-7-8 breathing technique, anxiety, bariatric surgery, deep breathing exercise, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 9 Aug 2022 (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.
Aim: This study aims to determine the effects of the deep breathing exercise and the 4-7-8 breathing technique applied to patients after bariatric surgery on their anxiety and quality of life.
Materials and Methods: The study was conducted between January and June 2022 at Ankara Lokman Hekim Akay Hospital Endocrinology and Metabolic Diseases Clinic. The research was carried out using the pre-test post-test randomized controlled experimental research design with a control group. A total of 90 patients (30 patients in the deep breathing group, 30 patients in the 4-7-8 breathing group, and 30 patients in the control group) who met the research inclusion criteria were included in the study. While routine care was applied to the control group, 1 group was given deep breathing training, and the other group was given 4-7-8 breathing training. Personal Information Form, the Obesity-Specific Quality of Life Questionnaire, Status, and the State-Trait Anxiety Inventory were used for data collection. In the evaluation of the data, number, percentage, mean, standard deviation, Kolmogorov Smirnov test, chi- square, dependent samples t-test, ANOVA, Tukey's test, Pearson Correlation analysis, and Cronbach's alpha Reliability Coefficient were used.
Detailed description
Obesity is a disease whose prevalence is increasing all over the world, reducing the quality and duration of life. Obesity affects the quality of life in all areas, including physiological, psychological, social and environmental aspects. Obesity causes anxiety, depression, low self-esteem and low body image in individuals. Obesity Bariatric surgery is considered to be the most effective and permanent method for weight loss in the treatment of cancer.
In the first month after bariatric surgery, unexpected conditions such as bleeding, thromboembolism, anastomotic leakage, and atelectasis may develop. In obese individuals, lung compliance decreases due to increased pulmonary blood volume and collapse in the peripheral airways. At the same time, excess adipose tissue accumulated in the chest wall and abdomen compresses the thorax and diaphragm, reducing lung volume. Positioning to relieve breathing, in-bed rotation movements, deep breathing and coughing exercises are the most important parts of nursing care, and interventions to prevent pulmonary complications in the postoperative period.
Anxiety is the whole of the natural reactions developed by the body and mind in the face of a situation or stimulus that disturbs the individual and endanger the existence. In everyday language, anxiety is expressed as anxiety and distress.
Gariepy et al. In a review by, it was seen that there is a positive relationship between obesity and anxiety disorders in general. Studies have shown that patients who are suitable for bariatric surgery among obese individuals have high levels of anxiety and depression, and generally have psychiatric disorders.
Anxiety seriously affects the quality of life negatively. The general picture that emerged in a study shows that anxiety impairs quality of life and social functionality in many areas of life. Brown and Roose found that anxiety and depression negatively affect quality of life psychologically and socially. In a study conducted by Çivi et al., when the mean quality of life scores and depression levels were compared, the mean quality of life scores of individuals with depression were found to be significantly lower than those without depression. In the study of Voelkerin and in the systematic review of Kolotkin and Andersen, it was stated that obesity reduces the quality of life. It is necessary to reduce the symptoms of depression and anxiety, to lose weight in a healthy way and to increase the quality of life.
In a study conducted by Ergen, it is recommended that respiratory exercises be routinely applied for the management of anxiety in the postoperative period. In a study by Yekta on mastectomy candidates, rhythmic breathing was found to be effective in reducing anxiety. Yusuf et al. In a study conducted by, it was determined that deep breathing exercise after surgery is an effective, inexpensive, easy and safe method in reducing the level of anxiety.
Holding the breath for a while allows the body to renew its oxygen. The 4-7-8 breathing technique provides the needed oxygen support to organs and tissues and helps to expel CO2. In the 4-7-8 breathing technique, inhale for 4 seconds, hold the breath for 7 seconds and exhale for 8 seconds. Such practices reduce anxiety by both distracting and providing relaxation by oxygenating and expelling the CO2 accumulated in the body.30 There is only one study on the 4-7-8 breathing technique. In the study of Pandekar et al., it was seen that the 4-7-8 breathing technique was effective in reducing anxiety and depression in moderate COPD patients.
It is the nurse's responsibility to provide a comfortable environment for the patient and to increase the quality of life standards. In addition, many studies show that the rate of use of non-pharmacological methods, which are the responsibility of nurses, is low. In this study, we predict that non-pharmacological deep breathing exercises and 4-7-8 breathing techniques will help reduce anxiety and increase the quality of life of patients undergoing bariatric surgery. It is the first study on the subject. This study was carried out to determine the effect of deep breathing exercise and 4-7-8 breathing technique on anxiety level and quality of life after bariatric surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The deep breathing group | Experimental | Other: The deep breathing groupThe deep breathing group was administered the nightly state and trait anxiety scale and SAAQ before the operation, and then they were informed about the deep breathing exercise. Between the 1st and 6th hours of the postoperative period, deep breathing exercise was performed, with 10 breaths per hour. At the end of the 6th hour, the state anxiety scale and SSWS were administered. |
| 4-7-8 breathing technique Group | Experimental | Other: 4-7-8 breathing techniqueThe nightly state and trait anxiety scale and the PSSQ were applied to the 4-7-8 breathing group before the operation, and then they were given information about the 4-7-8 breathing technique. Between the 1st and 6th hours postoperatively, the 4-7-8 breathing technique was applied for 1 set (4 breaths) every hour. At the end of the 6th hour, the state anxiety scale and SSWS were administered. |
| control group | No intervention | –In the control group, the nightly state and trait anxiety scale and PSSQ were applied before the operation. At the end of the 6th hour postoperatively, without any application, the state anxiety scale and PSSQ were applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older - 65 years or younger
- Being on the 1st postoperative day
- Have had bariatric surgery
- No communication barrier
- Have an ASA Score I or II
Key exclusion criteria (4 listed)
- Presence of major depression or psychosis
- Having a communication barrier
- Being transferred to another unit
- Leaving work voluntarily
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 |
|---|---|---|
| The deep breathing groupThe deep breathing group | Other | The deep breathing group |
| 4-7-8 breathing technique4-7-8 breathing technique Group | Other | 4-7-8 breathing technique Group |
Primary outcome
State and Trait Anxiety Inventory
Time frame: Change from State and Trait Anxiety Inventory at 24 hours
The state anxiety scale requires the person to answer at a certain moment and under certain conditions, while the trait anxiety scale requires the person to answer according to how he or she usually feels. This scale, which is a self-evaluation scale, consists of state anxiety and trait anxiety sections. It consists of a total of 40 questions, 20-20 in both. This scale is likert type and is graded as 'not at all-somewhat-very-completely'. The points that can be obtained from this inventory are minimum 20 and maximum 80 points. The scores obtained from the scale are interpreted as increasing the level of anxiety as it approaches 80, and the low level of anxiety as it approaches 20. It is interpreted in the same way when sorting by percentile.
Obese-Specific Quality of Life Scale
Time frame: Change from Quality of Life at 24 hours
This scale is a 17-item Likert-type scale scored between 0-6. According to the numerical increase order, it is expressed as 'Not at all, Hardly at all, Little, Moderate, Quite, A lot, Extremely'. The scale has no sub-dimensions. The scores obtained from all items of the scale are added together and 17 is subtracted from the obtained score. This score is divided by 102 and multiplied by 100. It is interpreted as the higher the score, the higher the quality of life, and the lower the score, the lower the quality of life.
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 9 Aug 2022.
- Derived from this study: PubMed 36480101Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The deep breathing group and 4-7-8 breathing technique in people with Postoperative Complications, run by Ataturk University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 9 Aug 2022. 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 Turkey (Türkiye). 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?
State and Trait Anxiety Inventory (time frame: Change from State and Trait Anxiety Inventory at 24 hours). The study lists 2 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 NCT05492929, which also lists 1 linked publication.
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 9 Aug 2022.