Effects of Reflexology and Cold Application Before Chest Tube Removal in CABG Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Being under 18 years of age
Using inotropic drugs
Having a history of chronic pain
Having a history of alcohol or drug use
Trial design
Design model
Parallel
Treatments tested in this trial
Reflexology
BehavioralA 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
BehavioralA 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
Treatment groups
108 Participants
are divided into 3 treatment groupsGroup A: Reflexology GroupExperimental treatment 1 intervention
Group B: Cold Application GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline (T1: initial), pre-procedure after intervention (T2: 40 minutes after initial), and 30 minutes post-procedure (T3).Secondary outcomes
1
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.
Time frame
30 minutes post-procedure (T3).2
Physiological Parameters (Systolic Blood Pressure)
Systolic blood pressure will be measured in mmHg using a non-invasive, calibrated blood pressure monitor to evaluate the physiological response of the patients.
Time frame
Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).3
Physiological Parameters (Diastolic Blood Pressure)
Diastolic blood pressure will be measured in mmHg using a non-invasive blood pressure monitor.
Time frame
Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).4
Physiological Parameters (Heart Rate)
Heart rate will be measured in beats per minute (bpm) using a pulse oximeter or cardiac monitor.
Time frame
Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).Sponsors and contacts
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Source ClinicalTrials.gov