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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Pain Intensity (Visual Analog Scale - VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Elastic Therapeutic Taping Group
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.
干预措施: Elastic therapeutic taping (Other)
Placebo Taping Group
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.
干预措施: Placebo Elastic Therapeutic Taping (Other)
Psychosocial Support Group
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.
干预措施: Therapeutic Taping on Non-Surgical Areas (Other)
结局指标
主要结局
Pain Intensity (Visual Analog Scale - VAS)
时间窗: 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).
次要结局
- Oxygen Saturation (SpO₂)(Baseline, 12 hours, 24 hours, and 48 hours after intervention)
- Fatigue Severity (VAS)(Baseline,12 hours, 24 hours, and 48 hours post-intervention)
- Pain Intensity While Coughing (VAS)(Baseline, 12 hours, 24 hours, and 48 hours post-intervention)
- Pain Intensity at Rest (VAS)(Baseline, 12 hours, 24 hours, and 48 hours post-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)
- Length of Hospital Stay(From the date of surgery until hospital discharge, assessed up to 30 days postoperatively.)
研究者
Alp Ozel
Assistant Professor
Abant Izzet Baysal University