Clinical trial NCT06910215: Effect of Elastic Therapeutic Taping on Post-Sternotomy Pain in Coronary Artery Bypass Graft Surgery
Official title: The Effectiveness of Elastic Therapeutic Taping in Pain Management After Sternotomy: A Randomized Controlled Double-Blind Study in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Postoperative Pain
Sternotomy
Pain Management
Coronary Artery Bypass
Keywords: Postoperative Pain
Sternotomy
Kinesio Tape
Anxiety
Sleep Quality
Coronary Artery Bypass
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity (Visual Analog Scale - VAS)
timeFrame: Baseline, 12 hours, 24 hours, and 48 hours after intervention
Secondary outcomes:
measure: Oxygen Saturation (SpO₂)
timeFrame: Baseline, 12 hours, 24 hours, and 48 hours after intervention
measure: Sleep Quality (VAS)
timeFrame: Baseline, 24 hours, and 48 hours after intervention
measure: Anxiety Level (VAS)
timeFrame: Baseline, 12 hours, 24 hours, and 48 hours post-intervention
measure: Functional Mobility (Timed Up and Go Test)
timeFrame: Baseline, 12 hours, 24 hours, and 48 hours after intervention
measure: Analgesic Use
timeFrame: 0-48 hours post-intervention
measure: Length of Hospital Stay
timeFrame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively.
measure: Fatigue Severity (VAS)
timeFrame: Baseline,12 hours, 24 hours, and 48 hours post-intervention
measure: Pain Intensity While Coughing (VAS)
timeFrame: Baseline, 12 hours, 24 hours, and 48 hours post-intervention
measure: Pain Intensity at Rest (VAS)
timeFrame: Baseline, 12 hours, 24 hours, and 48 hours post-intervention
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University
Study officials:
References: