Effects of Reflexology and Cold Application Before Chest Tube Removal in CABG Patients

Официальное название

Determining the Effects of Reflexology and Cold Application Before Chest Tube Removal on Pain, Anxiety, and Physiological Parameters in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Controlled Study

Обзор

This study aims to evaluate the effects of combined reflexology and cold application on pain, anxiety, and physiological parameters in patients undergoing chest tube removal (CTR) after coronary artery bypass grafting (CABG) surgery. Chest tube removal is an invasive procedure that often causes significant pain and anxiety, which can negatively impact the recovery process. In this randomized controlled trial, patients will be assigned to a combined intervention group (reflexology and cold application) or a control group. The study seeks to provide evidence-based recommendations for non-pharmacological nursing interventions to improve patient comfort and reduce complications during the post-operative period.

Подробное описание

This randomized, controlled, experimental study will be conducted with patients undergoing chest tube removal after CABG at the Gulhane Training and Research Hospital Cardiovascular Surgery Intensive Care Unit. Based on power analysis, a minimum of 108 patients will be enrolled and randomly assigned to three groups (1:1:1 ratio) using block randomization:

Combined Intervention Group: Patients will receive foot reflexology for 40 minutes (20 minutes per foot) and cold application (at -20°C/-30°C using a 13x13 cm cold pack applied over gauze for 20 minutes) immediately before chest tube removal.

Control Group: Patients will receive standard clinical care without additional interventions but will be monitored for their experiences and questions.

Data Collection:

Data will be collected using a Patient Identification Form, a Visual Analog Scale (VAS) for pain, the State-Trait Anxiety Inventory (STAI) for anxiety, and a Vital Signs Follow-up Form for physiological parameters (Blood Pressure, Heart Rate, Respiratory Rate, and Oxygen Saturation).

Procedures and Evaluation:

Measurements will be recorded at three time points: at initial contact (T1), after the intervention but before tube removal (T2), and 30 minutes after tube removal (T3). Statistical analysis will include independent t-tests, Mann-Whitney U, ANOVA, or Kruskal-Wallis tests depending on data distribution. The study aims to test the hypotheses that combined reflexology and cold application significantly reduce pain and anxiety while stabilizing physiological parameters.

Вмешательства

• Поведенческое Reflexology
  A trained researcher will apply foot reflexology for 40 minutes (20 minutes per foot) prior to chest tube removal. The intervention focuses on specific reflex points on the soles, dorsum, and toes of both feet to reduce pain and anxiety
• Поведенческое Cryotherapy alone
  A 13 cm x 13 cm cold pack, frozen for at least 2 hours at -20°C/-30°C, will be applied to the skin at the chest tube insertion site for 20 minutes before removal. The area will be covered with a gauze pad to prevent direct contact with the skin

Первичные конечные точки

• Severity of Post-Procedural Pain [Срок оценки: Baseline (T1: initial), pre-procedure after intervention (T2: 40 minutes after initial), and 30 minutes post-procedure (T3).]

Вторичные конечные точки (6)

• State Anxiety Level [Срок оценки: 30 minutes post-procedure (T3).]
• Physiological Parameters (Systolic Blood Pressure) [Срок оценки: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).]
• Physiological Parameters (Diastolic Blood Pressure) [Срок оценки: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).]
• Physiological Parameters (Heart Rate) [Срок оценки: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).]
• Respiratory Rate [Срок оценки: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).]
• Oxygen Saturation (SpO2) (%) [Срок оценки: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).]

Критерии участия

Критерии включения

• Being 18 years of age or older
• Not having undergone previous open heart surgery
• Not having received analgesics within 4 hours prior to the procedure
• Having a VAS pain score of 3 or higher
• Voluntary participation in the study

Критерии исключения

• Being under 18 years of age
• Using inotropic drugs
• Having a history of chronic pain
• Having a history of alcohol or drug use
• Having a psychiatric illness
• Having skin lesions, burns, or wounds on the feet that would prevent massage application

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Gulhane Training and Research Hospital — Ankara

Идентификаторы

NCT: NCT07528482 · 2025/15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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