Trials / Recruiting
RecruitingNCT07528482
Effects of Reflexology and Cold Application Before Chest Tube Removal in CABG Patients
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- Sponsor
- Ankara University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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 |
| BEHAVIORAL | 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 |
Timeline
- Start date
- 2025-12-15
- Primary completion
- 2026-05-04
- Completion
- 2026-05-04
- First posted
- 2026-04-14
- Last updated
- 2026-04-14
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07528482. Inclusion in this directory is not an endorsement.