Coronary Artery Bypass, Pain Management, Postoperative Pain, Sternotomy
Conditions
Keywords
Postoperative Pain, Sternotomy, Kinesio Tape, Anxiety, Sleep Quality, Coronary Artery Bypass
Brief summary
This research study aims to find out whether elastic therapeutic taping can help reduce pain after heart surgery, specifically coronary artery bypass grafting (CABG), which is done using a surgical cut through the breastbone (sternotomy). This type of surgery often causes pain that makes it hard for patients to breathe deeply, move around, or recover quickly. Managing this pain in a safe and effective way is important for better healing and quality of life. Elastic therapeutic taping is a method where special stretchy tape is applied to the skin to reduce pain and support the muscles. It is already used for other conditions like back or shoulder pain. In this study, researchers want to see if this taping method can also help people recover better after heart surgery by lowering pain, helping movement, and improving sleep and emotional well-being. A total of 195 participants who had planned (elective) CABG surgery will be included in the study. People will be placed into one of three groups: One group will get real elastic tape applied near the surgical area. One group will get fake (placebo) tape that looks the same but has no medical effect. One group will get a different kind of supportive treatment in other body areas. Neither the patients nor the people measuring the results will know which group each person is in. This is called a double-blind randomized controlled trial, which is the best way to get reliable results. The researchers will check each participant's pain levels using a visual scale, and will also look at other things like oxygen levels, sleep quality, anxiety, how well they move, and how much pain medicine they use. These checks will happen several times in the first two days after surgery. The taping is safe and non-invasive. Some people may experience mild skin irritation, but no serious side effects are expected. Participation is voluntary, and people can leave the study at any time. No payments will be made to participants, and all medical services related to the study will be free of charge. This study is supported by Bolu Abant Izzet Baysal University. The results may help offer a new, drug-free option for managing pain after heart surgery and may improve patients' recovery experience.
Detailed description
This randomized, controlled, double-blind clinical trial is designed to assess the efficacy of elastic therapeutic taping in reducing post-sternotomy pain in patients undergoing elective coronary artery bypass grafting (CABG) via median sternotomy. The study will be conducted at a single tertiary care center and will enroll 195 participants aged 18-75 years. Participants will be randomized into three equal groups (n = 65 per group) using a computer-generated block randomization method. Allocation concealment will be maintained using sealed opaque envelopes. The interventions will be applied within 6-8 hours after extubation in the intensive care unit, and participants will be followed for 48 hours post-intervention. Intervention Details: Elastic Therapeutic Taping Group: Kinesio tape will be applied bilaterally, approximately 3 cm lateral to the sternotomy incision. The tape will be applied using standardized protocols with 25-35% stretch, following the muscle facilitation technique for pain relief and proprioceptive input. Placebo Taping Group: Identical tape will be applied in the same locations, but without any stretch, and without following therapeutic taping principles. This group controls for the tactile and visual stimulus of taping. Sham Taping (Contextual Support) Group: Tape will be applied to non-surgical, compensatory areas (e.g., shoulders, paravertebral region, or intercostal muscles) using a standard method, but in locations unrelated to the surgical site. This group is intended to control for the psychological and contextual effects of physical touch and therapist interaction. All taping procedures will be performed by certified kinesio taping practitioners. The tape will remain in place for 48 hours unless early removal is required due to adverse skin reactions. Blinding: The study employs a double-blind design. Participants, outcome assessors, and data analysts will be blinded to group allocation. Intervention providers will not be involved in outcome assessment or data analysis. Data Collection and Monitoring: Primary and secondary outcome data will be collected at baseline (prior to intervention), and at 12, 24, and 48 hours post-intervention. Adherence to the intervention and any adverse events (e.g., skin irritation, allergic reaction) will be recorded. A dedicated safety officer will monitor for protocol adherence and unexpected complications. Statistical Plan: All analyses will follow an intention-to-treat approach. Descriptive statistics will summarize baseline characteristics. Normality will be assessed using the Shapiro-Wilk test. Between-group differences at each time point will be analyzed using one-way ANOVA or Kruskal-Wallis test. Repeated measures ANOVA or Friedman test will be used for within-group temporal comparisons. Bonferroni correction will adjust for multiple comparisons. Effect sizes (Cohen's d, partial eta squared) will be calculated. Ethical Considerations: The study protocol has been approved by the relevant institutional ethics committee. Written informed consent will be obtained from all participants. No experimental drugs or devices will be used. The tape used is CE-certified for medical use. The study adheres to the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. This study aims to provide high-quality evidence on the effectiveness of elastic therapeutic taping as a non-pharmacological intervention for managing early postoperative pain and improving recovery outcomes in CABG patients.
Interventions
OTHERElastic therapeutic taping
Elastic therapeutic taping is a non-invasive method that uses a specially designed elastic cotton tape applied directly to the skin. In this study, it is used to support pain management after open-heart surgery (CABG via sternotomy). The tape is applied near the surgical site to gently lift the skin, which may help reduce pain, improve circulation, and support healing. The application is done by a trained physiotherapist following a standardized taping protocol. The tape remains on the skin for up to 48 hours.
OTHERPlacebo Elastic Therapeutic Taping
In this group, the same type of elastic tape used in the therapeutic group is applied to the skin near the surgical area, but without any stretch or therapeutic technique. The tape does not provide physical support or intended therapeutic effects. It is used to help researchers understand whether any improvements are due to the taping itself or simply from receiving an intervention. The tape remains in place for up to 48 hours and is applied by trained personnel using a standardized, non-therapeutic method.
OTHERTherapeutic Taping on Non-Surgical Areas
In this group, elastic therapeutic tape is applied to body areas not directly related to the surgery, such as the shoulder, back, or rib area. The purpose is not to treat pain at the surgical site, but to simulate the experience of receiving a physical intervention. This approach helps researchers understand the potential impact of attention, expectation, or psychological support related to being part of a study. The tape is applied gently without therapeutic intent and stays on for up to 48 hours
Sponsors
Abant Izzet Baysal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years * Undergoing elective coronary artery bypass graft (CABG) surgery via sternotomy * Able to understand and communicate effectively * Willing to provide informed consent
Exclusion criteria
* Presence of dermatological conditions or open wounds in the sternotomy area * History of allergy to elastic therapeutic tape or adhesive materials * Diagnosis of neurological or psychiatric conditions that may affect pain perception * Currently taking medications that significantly alter pain sensitivity (e.g., neuropathic pain medications) * Participation in another interventional clinical study within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (Visual Analog Scale - VAS) | Baseline, 12 hours, 24 hours, and 48 hours after intervention | Change in pain intensity will be assessed using the Visual Analog Scale (VAS), a 100 mm horizontal line where participants rate their pain from 0 (no pain) to 100 (worst imaginable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality (VAS) | Baseline, 24 hours, and 48 hours after intervention | Participants will rate their sleep quality using a Visual Analog Scale (0 = very poor, 100 = excellent). |
| Anxiety Level (VAS) | Baseline, 12 hours, 24 hours, and 48 hours post-intervention | Participants will rate their anxiety level using a Visual Analog Scale (0 = no anxiety, 100 = extreme anxiety). |
| Functional Mobility (Timed Up and Go Test) | Baseline, 12 hours, 24 hours, and 48 hours after intervention | Time (in seconds) taken by participants to rise from a chair, walk 3 meters, turn around, walk back, and sit down. |
| Analgesic Use | 0-48 hours post-intervention | Total dosage of analgesic medication used during the first 48 hours post-surgery. |
| Oxygen Saturation (SpO₂) | Baseline, 12 hours, 24 hours, and 48 hours after intervention | Peripheral oxygen saturation measured using a pulse oximeter to assess potential respiratory improvement. |
| Fatigue Severity (VAS) | Baseline,12 hours, 24 hours, and 48 hours post-intervention | Participants will rate their level of fatigue on a 100 mm Visual Analog Scale, where 0 indicates no fatigue and 100 indicates extreme fatigue. |
| Pain Intensity While Coughing (VAS) | Baseline, 12 hours, 24 hours, and 48 hours post-intervention | Pain experienced during coughing will be measured using a 100 mm Visual Analog Scale, where 0 represents no pain and 100 represents worst possible pain. |
| Pain Intensity at Rest (VAS) | Baseline, 12 hours, 24 hours, and 48 hours post-intervention | Participants will rate their resting pain intensity using a 100 mm Visual Analog Scale (VAS), where 0 is no pain and 100 is worst pain imaginable. |
| Length of Hospital Stay | From the date of surgery until hospital discharge, assessed up to 30 days postoperatively. | Number of days from the date of surgery to the date of hospital discharge, as documented in the patient's medical record. |
Countries
Turkey (Türkiye)
Outcome results
None listed