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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05492929
Other study ID # vesile18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date July 5, 2022

Study information

Verified date August 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date July 5, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Presence of major depression or psychosis - Having a communication barrier - Being transferred to another unit - Leaving work voluntarily

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The deep breathing group
The deep breathing group
4-7-8 breathing technique
4-7-8 breathing technique Group

Locations

Country Name City State
Turkey Atatürk University Erzurum Palandöken

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Change from State and Trait Anxiety Inventory at 24 hours
Primary 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. Change from Quality of Life at 24 hours
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