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
| Registry | NCT07528482 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 108 (Actual) |
| Sponsor | Ankara University (Other) |
| Conditions | Pain, Acute Post-Operative, Anxiety, Chest Tube Removal, Coronary Artery Bypass |
| Interventions | Reflexology, Cryotherapy alone (Behavioral) |
| Dates | start 2025-12-15, primary completion 2026-04-08, completion 2026-05-04, first posted 2026-04-14, last updated 2026-10-21 |
| Locations | 1 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
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Reflexology Group | Experimental | Behavioral: Reflexology | Participants in this group received foot reflexology for 20 minutes (10 minutes per foot) before chest tube removal. |
| Cold Application Group | Experimental | Behavioral: Cryotherapy alone | Participants 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 Group | No intervention | Patients in this group will receive standard clinical care and monitoring, with no additional interventions. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Gulhane Training and Research Hospital | Ankara, Ankara | Turkey (Türkiye) |