Post Operative Pain Clinical Trial
— TapingOfficial title:
Investigation of The Effect of Kinesiology Tape on Pain, Respiratory Function and Respiratory Muscle Strength After Thoracotomy-A Randomized Controlled Study
Verified date | November 2022 |
Source | Akdeniz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Effective pain control after thoracotomy increases the patient's respiratory functions and related quality of life, reduces the length of hospital stay and the amount of analgesia use. Kinesiology taping has been used in sports injuries for many years and has been used in recent years to reduce pain after major surgery. This study was conducted to examine the effect of kinesiology taping on pain, respiratory function and respiratory muscle strength in patients who underwent thoracotomy.In this prospective randomized controlled experimental study, individuals between the ages of 20-75 who underwent thoracotomy with posterolateral thoracotomy and who agreed to participate in the study were included. Unlike the control group, kinesiology taping was applied to the study group for 7 days after surgery. Pain, respiratory functions, respiratory muscle strength, amount of analgesic drug use, and quality of life were evaluated preoperatively, postoperative day 0, before tape application, postoperative 1st day, postoperative 2nd day, postoperative 7th day and postoperative 1st month.
Status | Completed |
Enrollment | 88 |
Est. completion date | November 1, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: - Who underwent thoracotomy with a posterolateral thoracotomy incision - Who agreed to participate in the study, were aged 20-75 years - Who had no known cerebrovascular disease - Who had no morbid obesity and heart disease that would interfere with the study - Who had no cognitive and cognitive impairments that would interfere with communication Exclusion Criteria: - Who had chest trauma, thoracotomy or tube thoracostomy - Who had not complying with the pulmonary function test - Who are allergic to the tape |
Country | Name | City | State |
---|---|---|---|
Turkey | Neriman Temel Aksu | Antalya |
Lead Sponsor | Collaborator |
---|---|
Akdeniz University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Pain Score | The Visual Analog Scale (VAS) was used as a one-dimensional scale for pain assessment. VAS is a self-administered, one-dimensional measure of pain intensity widely used in various adult populations. The VAS is a 10 cm long line in which participants mark the point they believe best represents the severity of pain. Always "0" means no pain, while "10" means excruciating pain.
When asked, patients touch a point corresponding to their degree of pain, and this mark indicates the degree of pain on the scale. Higher scores indicate greater pain severity. Preoperative, postoperative day 0, pre-taping, postoperative 1st day, postoperative 2nd day, postoperative 7th day and postoperative 1st month were evaluated. |
Change from Baseline Pain Score at 4 weeks. | |
Primary | Change of Pulmonary Function | Pulmonary function testing was performed using a digital spirometer (Pony FX, COSMED Inc., Italy) with subjects in a comfortable 90-degree sitting position.This test was repeated 3 times for each patient and the best value was recorded. A 1-minute rest period was given between each test. Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), 1 second forced expiratory volume to forced vital capacity (FEV1/FVC), peak expiratory flow (PEF), 25-75% forced expiratory flow (FEF25-75) have been recorded. The tests were performed preoperatively, postoperative day 0, before tape application, postoperative day 1, postoperative day 2, postoperative day 7, and postoperative 1 month. | Change from Baseline Pulmonary Function at 4 weeks. | |
Primary | Change of Respiratory Muscle Strength | Respiratory muscle strength was evaluated by measuring maximal inspiratory and maximal expiratory pressures with a portable intraoral pressure measuring device (Pony FX, COSMED Inc., Italy). During the measurements, participants were verbally encouraged for maximum performance. The maneuvers were repeated at least 5 times at intervals of at least 30 seconds, and the best among the measurements with a 5-10% difference was selected for analysis. MIP and MEP values were determined as cmH2O. The tests were performed preoperatively, postoperative day 0, before tape application, postoperative day 1, postoperative day 2, postoperative day 7, and postoperative 1 month. | Change from Baseline Pulmonary Strenght at 4 weeks. | |
Primary | Change of Quality of Life | The Short Form-36 (SF-36) quality of life scoring was used to evaluate the quality of life of the patients. SF-36 is a questionnaire with 8 subscales that gives information about the health status and quality of life of the person. SF-36 was translated into Turkish in 1999. Confirmation studies were conducted in different patient groups.The tests were applied in the preoperative period, at the postoperative 1st month. | Change from Baseline Quality of Life at 4 weeks. | |
Secondary | Height in Meters | The height of all subjects in meters (m) will be noted before the surgery. | Initial assessment before surgery | |
Secondary | Weight in Kilograms | The weight of all subjects in kilograms (kg) will be noted before the surgery. | Initial assessment before surgery | |
Secondary | Body Mass Index (BMI) in kg/m^2 | Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2. | Initial assessment before surgery. |
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