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

NCT07528482 | Recruiting

• 1 other identifier: 2025/15
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Acute Post-Operative; Anxiety; Chest Tube Removal; Coronary Artery Bypass

Keywords

Reflexology; Cold Application; Chest Tube Removal Pain; Non-pharmacological Interventions; Nursing Care

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (6)

• State Anxiety Level

  30 minutes post-procedure (T3).

• Physiological Parameters (Systolic Blood Pressure)

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

• Physiological Parameters (Diastolic Blood Pressure)

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

• Physiological Parameters (Heart Rate)

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

• Respiratory Rate

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

Study Arms (3)

Reflexology Group

EXPERIMENTAL

Patients in this group will receive foot reflexology for 40 minutes (20 minutes for each foot) before chest tube removal.

Behavioral: Reflexology

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.

Behavioral: Cryotherapy alone

Control Group

NO INTERVENTION

Patients in this group will receive standard clinical care and monitoring, with no additional interventions.

Interventions

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

Reflexology Group

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

Cold Application Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Interventions

Musculoskeletal Manipulations; Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• neriman yükseltürk şimşek, assistant prof

  ankara u

  PRINCIPAL INVESTIGATOR

• yasemin özkan

  Gulhane Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

neriman yükseltürk şimşek, assistant prof.

CONTACT

0312 3042242; nerimansimsek@ankara.edu.tr

yasemin özkan, phd

CONTACT

03123042232; yasemininceozkan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: "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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant prof

Model Details: 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).

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 14, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): May 4, 2026
• Study Completion (Estimated): May 4, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)