Breathing Exercises Clinical Trial
Official title:
The Effect of Breathing Exercise on Pain, Anxiety, and Depression
NCT number | NCT04225169 |
Other study ID # | CankiriKU |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 23, 2019 |
Est. completion date | August 28, 2019 |
Verified date | January 2020 |
Source | Çankiri Karatekin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: After total knee replacement (TKR) surgery, patients often experience intense
levels of pain, stress, and anxiety that can adversely affect postoperative recovery.
Diaphragmatic breathing exercise (DBE) may help patients manage pain and emotional distress.
Aim: The aim of this study was to investigate the effect of DBE on pain, anxiety, and
depression in patients undergoing TKR.
Methods: The study population consisted of patients who underwent TKR surgery in the
orthopedic ward of Çankırı State Hospital between May and August 2019. The study sample
included a total of 38 patients satisfying the inclusion criteria. Stratified randomization
was used to assign the patients into sex-matched intervention group (n=19) and control group
(n=19). Patients in the intervention group were also trained in the DBE procedure. Pain
scores were evaluated at 1, 2, 4, 8, 12, and 24 hours postoperatively, while the anxiety and
depression was applied on the postoperative day 2. Data were analyzed using descriptive
statistics, Chi-square test, and Mann-Whitney U test.
Status | Completed |
Enrollment | 38 |
Est. completion date | August 28, 2019 |
Est. primary completion date | July 23, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Having total knee replacement Exclusion Criteria: - Dementia, - Alzheimer's disease, - Chronic obstructive pulmonary disease, - Psychiatric disorders, - hearing problems that prevented communication |
Country | Name | City | State |
---|---|---|---|
Turkey | Cankiri Karatekin University | Cankiri |
Lead Sponsor | Collaborator |
---|---|
Çankiri Karatekin University |
Turkey,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of mean postoperative pain scores of patients in the intervention and control groups | Visuel Analog Scale (VAS) This one-dimensional measure of pain intensity is a reliable and easily applicable scale that is widely accepted in the literature. VAS is used to convert nonmeasurable variables into numeric values. The 10-cm scale is labeled 0 ("no pain") at one end and 10 ("extreme pain") at the other, with values indicated at each cm in between | The intervention and control groups completed the VAS (Visuel Analog Scale) was applied at postoperative 1, 2, 4, 8, 12, and 24 hours | |
Primary | Comparison of mean postoperative anxiety and depression scores of patients in the intervention and control groups | Hospital Anxiety Depression Scale (HADS) The scale consists of 14 items, 7 of which assess signs of depression and 7 that assess signs of anxiety. Responses are evaluated on 4-point Likert-type scale scored between 0 and 3. However, responses to the even-numbered items decrease in severity and are scored from 3 to 0, while responses to the odd-numbered items are scored from 0 to 3. The sum of the odd-numbered items gives the anxiety score and the sum of the even-numbered items gives the depression score. The total score is not calculated. Minimum score 0, maximum score 42 higher scores mean a worse outcome. | HADS (Hospital Anxiety Depression Scale) was used on postoperative day 2 |
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