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NCT Number: NCT07528482

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

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.

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Key information

Conditions

Pain, Acute Post-Operative Anxiety Anxiety Disorders Chest Tube Removal Coronary Artery Bypass Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location status: Recruiting

Location contact

neriman Yükseltürk Şimşek, Assistant prof.

CONTACT

[email protected]

03123042242

yasemin özkan, PHD

SUB_INVESTIGATOR

yasemin özkan, phd

CONTACT

[email protected]

03123042241

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. Severity of Post-Procedural Pain

    Time frame: Baseline (T1: initial), pre-procedure after intervention (T2: 40 minutes after initial), and 30 minutes post-procedure (T3).

    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.

Secondary outcomes

  1. State Anxiety Level

    Time frame: 30 minutes post-procedure (T3).

    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.

  2. Physiological Parameters (Systolic Blood Pressure)

    Time frame: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).

    Systolic blood pressure will be measured in mmHg using a non-invasive, calibrated blood pressure monitor to evaluate the physiological response of the patients.

  3. Physiological Parameters (Diastolic Blood Pressure)

    Time frame: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).

    Diastolic blood pressure will be measured in mmHg using a non-invasive blood pressure monitor.

  4. Physiological Parameters (Heart Rate)

    Time frame: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).

    Heart rate will be measured in beats per minute (bpm) using a pulse oximeter or cardiac monitor.

  5. Respiratory Rate

    Time frame: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).

    Respiratory rate will be measured as the number of breaths per minute by observing the patient's chest movements for one full minute

  6. Oxygen Saturation (SpO2) (%)

    Time frame: Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).

    Oxygen saturation will be measured as a percentage (%) using a non-invasive pulse oximeter device attached to the patient's finger.

Study contacts

Contact information is provided by the study sponsor or research team.

neriman yükseltürk şimşek, assistant prof.

CONTACT

[email protected]

0312 3042242

yasemin özkan, phd

CONTACT

[email protected]

03123042232

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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