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

April 10, 2026 updated by: Neriman Yükseltürk Simşek, Ankara University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reflexology Group
Patients in this group will receive foot reflexology for 40 minutes (20 minutes for each foot) before chest tube removal.
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
Experimental: Cold Application Group
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.
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
No Intervention: Control Group
Patients in this group will receive standard clinical care and monitoring, with no additional interventions.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes post-procedure (T3).
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.
Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).
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.
Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).
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.
Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).
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
Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).
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.
Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: neriman yükseltürk şimşek, assistant prof, ankara u
  • Study Chair: yasemin özkan, Gulhane Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Estimated)

May 4, 2026

Study Completion (Estimated)

May 4, 2026

Study Registration Dates

First Submitted

April 4, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect participant privacy and confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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