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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reflexology Group | Experimental | Patients in this group will receive foot reflexology for 40 minutes (20 minutes for each foot) before chest tube removal. |
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| Cold Application Group | Experimental | Patients in this group will receive cold application using a cold pack (13x13 cm) at the tube site for 20 minutes before chest tube removal. |
|
| Control Group | No Intervention | Patients in this group will receive standard clinical care and monitoring, with no additional interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflexology | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Post-Procedural Pain | Pain severity will be measured using a Visual Analog Scale (VAS), where 0 represents 'no pain' and 10 represents 'the most severe pain imaginable.' Higher scores indicate greater pain intensity. | Baseline (T1: initial), pre-procedure after intervention (T2: 40 minutes after initial), and 30 minutes post-procedure (T3). |
| Measure | Description | Time Frame |
|---|---|---|
| State Anxiety Level | Anxiety levels will be measured using the State-Trait Anxiety Inventory (STAI). The state scale consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety. | 30 minutes post-procedure (T3). |
| Physiological Parameters (Systolic Blood Pressure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| neriman yükseltürk şimşek, assistant prof. | Contact | 0312 3042242 | nerimansimsek@ankara.edu.tr | |
| yasemin özkan, phd | Contact | 03123042232 | yasemininceozkan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| neriman yükseltürk şimşek, assistant prof | ankara u | Principal Investigator |
| yasemin özkan | Gulhane Training and Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulhane Training and Research Hospital | Recruiting | Ankara | 06010 | Turkey (Türkiye) |
Individual participant data will not be shared to protect participant privacy and confidentiality.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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This is a three-arm, randomized, parallel-controlled trial. The study uses a pre-test and post-test design with one intervention group (reflexology and cold application combined) and one control group (standard care).
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"Due to the nature of the interventions (foot reflexology and cold application), masking of participants and investigators was not possible. However, the data will be analyzed objectively.
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| Cryotherapy alone | Behavioral | 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 |
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Systolic blood pressure will be measured in mmHg using a non-invasive, calibrated blood pressure monitor to evaluate the physiological response of the patients. |
| Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3). |
| Physiological Parameters (Diastolic Blood Pressure) | Diastolic blood pressure will be measured in mmHg using a non-invasive blood pressure monitor. | Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3). |
| Physiological Parameters (Heart Rate) | Heart rate will be measured in beats per minute (bpm) using a pulse oximeter or cardiac monitor. | Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3). |
| Respiratory Rate | Respiratory rate will be measured as the number of breaths per minute by observing the patient's chest movements for one full minute | Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3). |
| Oxygen Saturation (SpO2) (%) | Oxygen saturation will be measured as a percentage (%) using a non-invasive pulse oximeter device attached to the patient's finger. | Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3). |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |