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

NCT07528482 — Not applicable, Completed, 108 participants, Ankara University

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The Effects of Foot Reflexology and Cold Application Administered Before Chest Tube Removal Following Coronary Artery Bypass Graft Surgery on Pain, State Anxiety, and Physiological Parameters: A Randomized Controlled Trial

RegistryNCT07528482
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment108 (Actual)
SponsorAnkara University (Other)
ConditionsPain, Acute Post-Operative, Anxiety, Chest Tube Removal, Coronary Artery Bypass
InterventionsReflexology, Cryotherapy alone (Behavioral)
Datesstart 2025-12-15, primary completion 2026-04-08, completion 2026-05-04, first posted 2026-04-14, last updated 2026-10-21
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Pain, Acute Post-Operative All trials for Anxiety All trials of Reflexology All trials of Cryotherapy alone

-Summary

This randomized controlled trial evaluated the effects of foot reflexology and cold application, administered separately before chest tube removal, on pain, state anxiety, and physiological parameters in patients following coronary artery bypass graft (CABG) surgery. A total of 108 patients were assigned to a foot reflexology group, a cold application group, or a control group receiving routine care. Outcomes were assessed before the intervention, immediately before chest tube removal, and 30 minutes after removal. The study compared changes in these outcomes across the three groups.

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+Detailed description

Detailed Description This three-arm, parallel-group randomized controlled trial evaluated the effects of foot reflexology and cold application administered before chest tube removal on pain, state anxiety, and physiological parameters in patients following coronary artery bypass graft (CABG) surgery.

A total of 108 patients were randomized in a 1:1:1 ratio to the foot reflexology, cold application, or control group, with 36 participants in each group. Participants received a single 20-minute session of foot reflexology (10 minutes per foot), a 20-minute cold application using a 13 × 13 cm cold gel pack placed over gauze on the dressing around the chest tube, or a 20-minute rest period with routine clinical care and no additional nonpharmacological intervention, respectively. Chest tube removal was performed using the same standard clinical procedure in all groups.

Data were collected using a Patient Demographic Information Form, the Visual Analog Scale (VAS) for pain, the State-Trait Anxiety Inventory-State subscale (STAI-I), and a Vital Signs Monitoring Form. Pain, state anxiety, systolic and diastolic blood pressure, pulse rate, respiratory rate, and oxygen saturation were assessed at baseline before the intervention (T1), immediately after the intervention and before chest tube removal (T2), and 30 minutes after removal (T3).

The primary outcome was the VAS pain score at T3. Pain and state anxiety were analyzed using mixed-design ANCOVA, with the corresponding baseline score included as a covariate. Physiological parameters were analyzed using a three-group-by-three-time mixed-design ANOVA. The study assessed whether changes in pain, state anxiety, and physiological parameters differed among the three groups over time.

+Arms and interventions

ArmTypeInterventionsDescription
Reflexology GroupExperimentalBehavioral: ReflexologyParticipants in this group received foot reflexology for 20 minutes (10 minutes per foot) before chest tube removal.
Cold Application GroupExperimentalBehavioral: Cryotherapy aloneParticipants in this group received a 20-minute cold application using a 13 × 13 cm cold gel pack wrapped in gauze and placed over the dressing around the chest tube before removal.
Control GroupNo interventionPatients in this group will receive standard clinical care and monitoring, with no additional 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
  • 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

+Outcome measures

Primary outcomes

  • Pain intensity 30 minutes after chest tube removal [30 minutes after chest tube removal (T3).]: Pain intensity was measured using a 10-cm Visual Analog Scale (VAS), ranging from 0 ("no pain at all") to 10 ("unbearable pain"). Higher scores indicate greater pain intensity.

Secondary outcomes

  • State anxiety score [At baseline before the intervention (T1), immediately after the intervention or waiting period and before chest tube removal (T2), and 30 minutes after chest tube removal (T3).]: State anxiety was assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-I), a 20-item scale with total scores ranging from 20 to 80. Higher scores indicate greater state anxiety.
  • Physiological Parameters (Systolic Blood Pressure) [At baseline before the intervention (T1), immediately after the intervention or waiting period and before chest tube removal (T2), and 30 minutes after chest tube removal (T3).]: Systolic blood pressure was measured in mmHg using a standard bedside monitor.
  • Physiological Parameters (Diastolic Blood Pressure) [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.
  • Physiological Parameters (Pulse rate) [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.
  • Respiratory Rate [At baseline before the intervention (T1), immediately after the 20-minute intervention or waiting period and before chest tube removal (T2), and 30 minutes after chest tube removal (T3).]: Respiratory rate was monitored using a standard bedside monitor and recorded in breaths per minute.
  • Oxygen Saturation (SpO2) (%) [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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria

Aged 18 years or older Undergoing chest tube removal following first-time coronary artery bypass graft (CABG) surgery No history of previous open-heart surgery No systemic analgesic use within 4 hours before the intervention Able to communicate and oriented Willing to participate voluntarily and able to provide written informed consent Exclusion Criteria

Hemodynamic instability or use of inotropic medication History of chronic pain History of alcohol or substance abuse or dependence A diagnosed psychiatric disorder that could affect communication or the ability to complete the study scales Foot lesions, neuropathy, peripheral vascular disease, infection, burns, or open wounds that could prevent reflexology Lower-extremity amputation Local infection or an open wound at the chest tube insertion site that could prevent cold application

+Locations (1)

FacilityCityCountryStatus
Gulhane Training and Research HospitalAnkara, AnkaraTurkey (Türkiye)

+Investigators

  • neriman yükseltürk şimşek, assistant prof, Principal investigator, ankara u
  • yasemin özkan, Study chair, Gulhane Training and Research Hospital