- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07098962
- Original Trial
KinesioTaping for Thoracic Drain Support (KT-Drain)
Effect of KinesioTaping on Pain at Mediastinal-Thoracic Tube Sites After Cardiac Surgery: A Randomized Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain following cardiac surgery is a significant clinical concern that can hinder early mobilization, reduce patient satisfaction, prolong hospital stay, and increase the risk of respiratory complications such as atelectasis and pneumonia. While pharmacological analgesia remains the mainstay of treatment, non-pharmacological adjuncts are increasingly being explored to enhance pain control and reduce reliance on opioids.
KinesioTaping (KT), a method originally developed for musculoskeletal conditions, involves the application of elastic therapeutic tape to the skin with the aim of supporting soft tissue structures, enhancing lymphatic and blood flow, and modulating nociceptive input via stimulation of cutaneous mechanoreceptors. In the context of postoperative care, KT may also help reduce localized edema, support incision sites, and promote a sense of physical stability that contributes to pain relief.
Despite its growing popularity in rehabilitation and sports medicine, the use of KinesioTaping in postoperative settings-particularly in cardiothoracic surgery-remains under-investigated. Limited studies have suggested potential benefits in reducing pain and improving functional outcomes, but current evidence is inconclusive and often methodologically limited.
This prospective, randomized controlled trial aims to evaluate the effectiveness of KinesioTaping when applied around mediastinal and thoracic drain sites in patients undergoing cardiac surgery. The primary objective is to assess postoperative pain levels using validated pain scales (e.g., VAS) in patients receiving KT versus those receiving standard care without taping. Secondary outcomes include opioid consumption, time to ambulation, respiratory function (spirometry or incentive spirometry use), incidence of atelectasis, and patient satisfaction scores.
By providing high-quality evidence on a low-cost, non-invasive, and easily applicable intervention, this study seeks to clarify the potential role of KinesioTaping as an adjunctive tool in postoperative pain management protocols following cardiac surgery.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Kastamonu
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Kastamonu, Kastamonu, Turkey (Türkiye), 37200
- Kastamonu Education and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Elective cardiac surgery cases
- Patients who are stable until the removal of the chest drain
- Patients who do not experience serious complications such as bleeding or neurological problems
Exclusion Criteria:
- Patients undergoing emergency cardiac surgery,
- Patients with early post-cardiac surgery mortality,
- Patients with conditions requiring reoperation, such as bleeding,
- Patients for whom a pain score cannot be measured, such as neurological complications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesiotaping group
In this group, KinesioTaping will be applied alongside routine pain management.
|
In this group, KinesioTaping will be applied around the thoracic drain sites alongside standard analgesic therapy.
This physical therapy technique uses elastic tapes placed on the skin to support healing, reduce pain, and improve patient comfort.
The tapes will remain in place for 2-3 days and will be removed together with the drains.
Other Names:
|
|
Active Comparator: Routine treatment group
This group will be managed with standard hospital-based painkiller administration.
|
Patients in this group will be treated with painkillers consisting of tramadol and dexketoprofen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Day 3 Visual Analogue Scale Pain Score
Time Frame: 3 day
|
Visual analog scale pain score on the 3th day after cardiac surgery. Pain is defined as no pain (0) or unbearable pain (10). 0 = No pain, 1-3 = Mild pain, 4-6 = Moderate pain, 7-10 = Severe pain |
3 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KastamonuUnii
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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