Introduction
Cardiovascular disease represents a critical health issue globally [1]. Coronary artery disease (CAD) stands as a primary contributor to mortality worldwide, with its prevalence steadily increasing. A common intervention for CAD is coronary artery bypass grafting (CABG) surgery [2]. Bacher and Mana prognosticate that by 2024, approximately 400 000 CABG procedures will be performed annually [3]. 
Despite the advantageous outcomes associated with CABG, anxiety is a frequent companion to this surgical procedure [4]. Anxiety often correlates with various physiological responses, including heightened metabolism, compromised cardiovascular functionality, and a weakened immune response. Such reactions may present as tachycardia, difficulties in respiration, hypertension, and variations in body temperature. The hypertensive state induced by anxiety may raise the risks of suture hemorrhage and even the rupture of graft anastomosis after CABG surgery [5]. Management strategies for anxiety can be categorized into pharmacological and non-pharmacological approaches. While pharmacological treatments may offer relief, they often bring along adverse effects, such as disturbances in vital functions (like blood pressure, respiration, and heart rate [HR]), as well as drowsiness, nausea, or vomiting, ultimately escalating healthcare operational costs. In recent years, there has been a growing interest in non-pharmacological methods for reducing anxiety due to their simplicity, cost-efficiency, non-invasive nature, and fewer side effects compared to medication. Common non-pharmacological interventions comprise music therapy, aromatherapy, muscle relaxation techniques, and massage therapy, with foot reflexology emerging as a widely practiced modality grounded in reflexology principles [6-8].
Research has demonstrated the beneficial effects of reflexology in mitigating pain, headaches, anxiety, pre-and post-natal symptoms, migraines, cardiovascular complications, gastrointestinal disorders, wound healing, and regulating blood sugar levels. Reflexologists advocate that there are specific reflex points on the extremities that correspond to distinct regions, organs, and glands within the body. This technique mitigates stress and anxiety by calming the sympathetic nervous system’s fluctuations [9-13]. Previous studies have shown that reflexology applied to the feet, hands, and ears can effectively lower systolic blood pressure (SBP) and diastolic blood pressure (DBP), HR, and respiratory rate (RR) in mechanically ventilated patients [14, 15]. Nevertheless, few empirical studies have investigated the effects of foot reflexology massage on anxiety and physiological indices in individuals undergoing CABG. Some studies indicate that foot reflexology may be advantageous in alleviating anxiety and promoting stability in patients facing various complications [16, 17]. Conversely, other research suggests that the influence of foot reflexology on physiological indices in CABG patients is minimal [18, 19]. 
In light of the conflicting results concerning the effects of foot reflexology massage on anxiety and physiological indices, combined with the notable occurrence of anxiety following CABG, this study investigates the effects of foot reflexology massage on both anxiety and physiological indices in patients undergoing CABG.

Materials and Methods
This study was designed as a quasi-experimental clinical trial involving patients undergoing CABG in the surgical unit at Dr. Heshmat Hospital in Rasht City, Iran. The data were collected through convenience sampling. The sample size was calculated using G*Power software, version 3.1.9.2 [20]. This calculation was performed for a one-way analysis of variance, aimed at achieving a power of 0.8, an α level of 0.05, and a moderate effect size related to anxiety scores (f=0.4). This process indicated that a minimum sample size of 37 patients was necessary. Accounting for a 5% attrition rate due to potential dropouts and technical complications, a total of 40 patients were recruited for participation.
The inclusion criteria for the study included patients aged 20 to 80 years, those undergoing non-emergency surgeries, individuals with healthy feet, and without any history of cardiac pacemaker implantation, substance (alcohol or drug) abuse, chronic pain, visual or auditory impairments, or existing depression and anxiety. Moreover, the participants were required to abstain from analgesic or sedative medications for 3 h before the intervention, and should not have experienced any disorder during surgery or hospitalization that might influence their anxiety levels [20]. Sampling was conducted through the block randomization method via 2019 Sealed Envelope Ltd [21], employing blocks of size 6 for three groups: Foot reflexology massage, routine care, and a control group.
Data collection was accomplished using a two-part questionnaire. The first section gathered demographic information and physiological metrics, while the second section utilized the Spielberger anxiety questionnaire. The researchers reported favorable reliability for the 6-item Spielberger questionnaire, with a reliability coefficient of α=0.86 [22]. Responses were evaluated using a 4-point likert scale (“not at all,” “somewhat,” “moderately,” and “very high”) for each item. The test scores ranged from 6 to 24, with scores of 6-11 indicating mild anxiety, 12-17 indicating moderate anxiety, and 18-24 classified as severe anxiety. The correlation between the short form and the full version of the questionnaire yielded a coefficient of 0.96. The scoring system of the anxiety questionnaire was designed to provide multiple options for each statement, allowing participants to select the choice that most accurately reflected their feelings. A higher score on this questionnaire signified increased anxiety severity [22].
Following the acquisition of the ethics code (IR.GUMS.REC.1399.041) from the Vice Chancellor for Research at Guilan University of Medical Sciences, the study’s objectives and the massage technique were explained to the participants in collaboration with a specialist physician, and written informed consent was obtained. A licensed massage therapist performed the foot reflexology massage. On the first day of the patients’ transfer to the surgical ward, anxiety levels were assessed and documented in all three groups using the Spielberger questionnaire and physiological metrics (SBP, DBP, HR, RR, and arterial oxygen saturation [SaO2]) through the VISTA vital sign monitoring device.
In the experimental group, foot reflexology massage was carried out. The procedure involved washing the hands with warm water, applying sweet almond oil, and massaging the soles of the feet, with a particular focus on key reflex points. The intervention was administered for 15 min on each leg (the right leg first, followed by the left leg), culminating in a total duration of 30 min. During 10-min post-intervention, the patient’s anxiety levels and physiological metrics were reassessed and recorded. In the control group, no intervention was implemented, and both anxiety levels and physiological indicators were measured twice, with a 30-min interval between assessments. For the placebo group, superficial heel massage was conducted without any applied pressure, and after 10 minutes, anxiety and physiological parameters were recorded once again.
Continuous variables were expressed as Mean±SD, while categorical variables were presented as frequency (percentage). The analysis of covariance, complemented by the Bonferroni test, was employed to compare the groups while adjusting for pre-test scores. Additionally, effect sizes were reported as partial Eta squared (η²p) for the analysis of covariance [23]; η²p values of 0.01, 0.06, and 0.14 were classified as low, moderate, and high effect sizes, respectively. Data analysis was performed using the SPSS software, version 16.0 (SPSS Inc., Chicago, IL, USA), with a P<0.05 considered statistically significant.

Results
A total of 140 patients were assessed for eligibility, with 120 patients successfully randomized into the study. The randomization process began in October 2020, concluding in March 2021. Follow-up data were fully available for all 120 participants (100%), facilitating their inclusion in the intention-to-treat analysis (Figure 1). 




Demographics and clinical characteristics
Table 1 presents the demographic and clinical features of the participants. The mean age of the patients was 58.38±9.03 years, with a mean body mass index of 27.97±3.26 kg/m². Among the participants, 64.2% were male, 99.2% were married, and 73.3% lived in urban areas. A significant proportion of the sample reported smoking (58.3%), while 53.5% were self-employed. Additionally, 64.2% had a history of diabetes mellitus, and 52.5% had a history of cardiovascular disease. Demographic and clinical characteristics were uniformly balanced across the groups.



Anxiety scores
Before the intervention, a comparison of mean anxiety scores among the control, superficial foot massage, and reflexology foot massage groups revealed no significant differences. Post-intervention results showed that the mean anxiety score in the experimental group was (15.32±3.59), which marked a significant decrease from the pre-intervention mean anxiety score (20.38±3.91; d=1.674, P<0.001, t=10.46). The placebo group exhibited a similar trend, with a post-intervention mean anxiety score of (20.65±2.78), lower than the pre-intervention score of (21.28±2.74; d=0.342, P=0.039, t=2.14). In contrast, the control group showed no significant change in mean anxiety scores, with pre-intervention scores (21.58±3.21) and post-intervention scores (21.52±3.20; d=0.160, P=0.323, t=1.00). Based on Cohen’s d values, the effect size in the reflexology foot massage group was classified as high, whereas the superficial foot massage group exhibited a lower effect size (Table 2).



Blood pressure measurements
Post-intervention, the experimental group demonstrated a significant decrease in mean SBP, recorded at (121.68±15.71), compared to the pre-intervention level of (132.02±18.89) (d=1.504, P<0.001, t=9.39). The placebo group also showed a significant reduction in SBP after the intervention (125.20±14.34), compared to pre-intervention (127.22±14.12; d=0.535, P=0.002, t=3.34). However, no significant differences were seen in the control group, where SBP measurements before (119.05±17.26) and after intervention (116.72±18.15) showed no substantial change (d=0.156, P=0.336, t=0.97). The effect sizes, according to Cohen’s d values, were categorized as high and moderate for the reflexology and superficial foot massage groups, respectively. The mean DBP in the experimental group post-intervention (74.82±11.66) was significantly lower than the pre-intervention measure (78.92±11.13; d=0.911, P<0.001, t=5.69). In both the placebo and control groups, no significant changes in DBP were recorded (Table 3).



Pulse rate analysis
The mean pulse rate in the experimental group post-intervention (84.40±9.90) was significantly lower than pre-intervention (89.58±10.46; d=1.129, P<0.001, t=7.05). The placebo group also exhibited a significant reduction, with a post-intervention pulse rate (80.25±8.72) compared to (81.52±9.52) before the intervention (d=0.582, P<0.001, t=3.63). Conversely, no significant difference in mean pulse rate was observed in the control group (79.02±8.07 pre-intervention vs 79.05±8.51 post-intervention; d=0.015, P=0.925, t=0.09). Effect sizes, as per Cohen’s d values, were rated as high and moderate for the reflexology and superficial foot massage groups, respectively (Table 4).



RR and oxygen saturation
After the intervention, the mean RR in the experimental group (19.58±0.93) was notably lower than the pre-intervention rate (20.50±1.20; d=0.727, P<0.001, t=4.54). The placebo group did not demonstrate a significant change in RRs before (19.82±1.22) and after (19.68±1.31) intervention (d=0.285, P=0.083, t=1.79). Similar results were observed in the control group, with pre-intervention (19.62±1.08) and post-intervention (19.65±1.08) rates showing no significant differences (d=0.160, P=0.323, t=1.00). The medium effect size was determined in the foot reflexology massage group for RR.
Lastly, the mean SaO2 after the intervention in the experimental group (95.85±2.30) significantly exceeded the pre-intervention measurement (94.75±2.61; d=0.989, P<0.001, t=6.17). Conversely, neither the placebo group (mean SaO2 before=95.40±2.10 vs SaO2 after=95.60±1.92) nor the control group (before=95.90±1.60 vs after=95.85±1.64) displayed significant changes in SaO2 levels (Table 5).



Discussion 
This investigation focused on the effects of foot reflexology massage on anxiety levels and physiological parameters (SBP and DBP, HR, RR, and SaO2) in patients undergoing CABG. The cohort was predominantly male (64.2%) with a mean age of 58.38±9.03 years. Notably, 58.3% of participants had a smoking history, and 62.4% reported a history of diabetes.

Anxiety reduction
The results demonstrated significant reductions in mean anxiety scores in both the foot reflexology and superficial foot massage groups post-intervention (P<0.05). In contrast, the control group showed no significant change, suggesting that both reflexology and superficial massage effectively alleviate anxiety in CABG patients.
Adjusted mean anxiety scores revealed that the foot reflexology group had significantly lower scores compared to both the control and superficial foot massage groups. No notable differences were observed between the superficial massage and control groups. These findings are consistent with those of Abbaszadeh’s study, who also indicated that foot reflexology has a significant impact on reducing anxiety levels compared to control groups [26]. Similarly, research by Bagheri [16] and Shahsavari [18] corroborates these findings, reporting substantial reductions in anxiety levels due to foot reflexology among patients undergoing CABG, coronary artery angiography, and bronchoscopy, respectively. Furthermore, Rigi [22] and Hasavari [27] observed a significant decrease in anxiety levels among patients receiving reflexology massage, with no significant differences noted in the control group. Conversely, studies by Kavei [28] and Gunnarsdottir [29] reported that foot reflexology had no significant impact on anxiety in patients undergoing CABG and mechanical ventilation. The limitations of Gunnarsdottir’s study, particularly its small sample size of 9 patients, may undermine its reliability. Kavei’s timing of the reflexology intervention, shortly after intensive care unit admission when patients were still under the effects of anesthetics, could have influenced results, as participants had not yet completely regained consciousness, potentially increasing anxiety levels [28]. 
Thus, our research highlights foot reflexology massage as a beneficial approach to promoting relaxation and reducing anxiety in patients undergoing CABG.

Physiological parameter analysis
The study also found significant reductions in mean SBP in both the intervention and placebo groups post-intervention (P<0.05), with the intervention group exhibiting significantly lower SBP than both control and placebo groups. Abbaszadeh similarly reported that foot reflexology significantly affects SBP compared to control groups [24]. Additional studies corroborated these results, indicating that foot reflexology reduces cardiovascular parameters in healthy individuals and lowers SBP in patients with multiple sclerosis [29, 30]. Korhan also found that reflexology decreased BP, RR, and HR in mechanically ventilated patients [31]. However, Ebadi, Jones, and Rollinson reported minimal impacts of foot reflexology on physiological parameters in CABG patients and other conditions [18, 19, 32]. The reliability of Ebadi’s findings may be compromised due to the timing of the intervention, as it was administered merely one hour after intensive care unit admission, while patients were still under anesthetic influence. The results of Rollinson and Jones may also have been affected by their small sample size (12 patients). Therefore, foot reflexology massage appears promising in mitigating complications by reducing SBP in CABG patients.
The present findings show that the mean DBP in the intervention group significantly decreased (P<0.05), while no notable changes were observed in the placebo and control groups. Abbaszadeh similarly noted significant effects of foot reflexology on DBP compared to controls [26]. However, conflicting conclusions were presented by Padial and Somchock, who reported increased DBP due to foot reflexology [33, 34]. Khoshtarash’s research found no significant changes in DBP following reflexology after cesarean section [35].
In terms of HR, significant decreases were observed in both the intervention and placebo groups post-intervention, while no significant differences were noted in the control group. The adjusted mean HR in the intervention group was significantly lower than in both the placebo and control groups, mirroring findings from Abbaszadeh’s study, which found that foot reflexology had no significant influence on HR compared to control groups [26]. Padial reported increased HR in healthy people due to foot reflexology, while Khoshtarash found no significant differences in HR after cesarean sections [33, 35]. Improved measurement tools may yield diverse results regarding these variables.
An analysis of mean RR showed a significant decrease in the intervention group post-intervention (P<0.05), with no significant differences in the placebo and control groups. The adjusted mean RR was statistically lower in the intervention group compared to the placebo and control groups (P<0.001 and P=0.003, respectively). Wang’s study noted significant decreases in both HR and RR following reflexology intervention [36]. Further corroboration comes from Abbaszadeh, who indicated that foot reflexology significantly affected patient RR levels. Babatabar’s findings also showed notable reductions in HR and RR following reflexology in open-heart surgery patients [37]. In contrast, Bozorgzad found no statistically significant differences in physiological parameters across groups in his study on pain intensity after CABG [38].

Oxygen saturation changes
The current study found that mean SaO2 levels significantly increased in the intervention group, with no notable differences within the placebo and control groups. Abbaszadeh also noted significant influences of foot reflexology massage on average SaO2 levels compared to controls [26]. However, Babatabar’s study showed no significant differences in SaO2 during chest tube removal across various measured intervals (immediacy, 5 min, 10 min, and 15 min post-intervention) [37].

Conclusion
This study provides evidence that anxiety levels and physiological indices (SBP, DBP, HR, RR, and SaO2) significantly decreased in the reflexology group among patients who underwent CABG surgery. The implementation of foot reflexology massage as an accessible and cost-effective intervention can enhance patient care, accelerate recovery post-CABG, and potentially reduce hospitalization duration and overall treatment costs.
Several factors, including patient demographics and clinical conditions, can influence reflexology outcomes. As such, caution should be exercised when interpreting these findings, and further exploration is warranted in this field to validate these results.

Ethical Considerations

Compliance with ethical guidelines
This study received approval from the Ethics Committee of Guilan University of Medical Sciences, Rasht, Iran (Ethics Code: IR.GUMS.REC.1399.041). All patients were informed about the study’s aims and voluntarily participated. The trial was registered at Ranian Registry of Clinical Trials (Trial Registration Number: IRCT20080825001083N10).

Funding
This article is based on the master’s thesis of Mehri Shahidi, approved by the Department of Medical Surgical Nursing, School of Nursing and Midwifery, Guilan University of Medical Sciences, with support from the Deputy of Research and Technology of Guilan University of Medical Sciences. 

Authors' contributions
Conceptualization: Majid Pourshaikhian and, Mohammad Taghi Moghadamnia; Methodology, and Data Analysis: Saman Maroufizadeh; Validation: Saman Maroufizadeh, Mehri Shahidi; Research: Mehri Shahidi and, Negar Pourvakhshoori;  Writing the Initial Draft, and Supervision: Majid Pourshaikhian; Editing and Final Approval of the Manuscript: Negar Pourvakhshoori, Project Management: Majid Pourshaikhian and, Mohammad Taghi Moghadamnia.

Conflict of interest
The authors declare no conflict of interest.

Acknowledgments
The authors express their thanks to the patients who took part in this study.



 

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