Effect of Elastic Therapeutic Taping on Post-Sternotomy Pain in Coronary Artery Bypass Graft Surgery

NCT06910215 | Completed

• 1 other identifier: AIBU-FTR-AO-03
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Sternotomy; Pain Management; Coronary Artery Bypass; Postoperative Pain

Keywords

Postoperative Pain; Sternotomy; Kinesio Tape; Anxiety; Sleep Quality; Coronary Artery Bypass

Outcome Measures

Primary Outcomes (1)

• Pain Intensity (Visual Analog Scale - VAS)

  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).

  Baseline, 12 hours, 24 hours, and 48 hours after intervention

Secondary Outcomes (9)

• Oxygen Saturation (SpO₂)

  Baseline, 12 hours, 24 hours, and 48 hours after intervention

• Sleep Quality (VAS)

  Baseline, 24 hours, and 48 hours after intervention

• Anxiety Level (VAS)

  Baseline, 12 hours, 24 hours, and 48 hours post-intervention

• Functional Mobility (Timed Up and Go Test)

  Baseline, 12 hours, 24 hours, and 48 hours after intervention

• Analgesic Use

  0-48 hours post-intervention

Study Arms (3)

Elastic Therapeutic Taping Group

EXPERIMENTAL

Participants in this group will receive elastic therapeutic taping (kinesio taping) applied bilaterally 3 cm lateral to the sternotomy incision site. The tape will be applied with standardized tension and technique by a trained physiotherapist within 24 hours post-CABG surgery. The tape will remain in place for 48 hours. The goal is to assess the therapeutic effect of kinesio taping on postoperative pain and related outcomes.

Other: Elastic therapeutic taping

Placebo Taping Group

PLACEBO COMPARATOR

Participants in this group will receive placebo taping to the same area (3 cm lateral to the sternotomy incision), using the same type of tape but without any tension or therapeutic intent. The tape will be applied by the same trained team, in an identical manner visually, but with no mechanical stretch. The tape will also remain in place for 48 hours. This will help control for the placebo effect of the taping procedure.

Other: Placebo Elastic Therapeutic Taping

Psychosocial Support Group

SHAM COMPARATOR

Participants in this group will receive elastic therapeutic tape applied to unrelated regions of the body (e.g., shoulder, back, or intercostal muscles) not associated with the surgical area. The purpose is to account for contextual or psychosocial effects of receiving an intervention. The tape will be applied without therapeutic intent for the surgical pain, and will stay in place for 48 hours.

Other: Therapeutic Taping on Non-Surgical Areas

Interventions

Placebo Elastic Therapeutic Taping OTHER

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.

Placebo Taping Group

Therapeutic Taping on Non-Surgical Areas OTHER

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

Psychosocial Support Group

Elastic therapeutic taping OTHER

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.

Elastic Therapeutic Taping Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 4, 2025
• Study Start: January 22, 2025
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data will be made available beginning 6 months after publication of the primary results and will remain available for up to 3 years upon request.
• Access Criteria: Researchers may request access to the de-identified individual participant data (IPD) and supporting documents (e.g., protocol, SAP, ICF, analytic code) by submitting a written proposal that includes a clear research question and analysis plan. Requests should be sent to the Principal Investigator via institutional email. All requests will be reviewed by the research team and relevant ethics committee. If approved, data will be shared under a formal data use agreement. Data will be provided through a secure, password-protected digital platform.

Locations

TU (1)