Comparing the Effects of Warm Footbath and Foot Reflexology on the Fatigue of Patients Undergoing Radiotherapy: A Randomized Clinical Trial

Abstract

Background and Aim:

Fatigue is a common side effect of radiotherapy. While warm footbath and foot reflexology can both reduce fatigue, it is still unclear which method is more effective in reducing fatigue. This study aimed to compare the effects of warm footbath and foot reflexology on the fatigue of patients undergoing radiotherapy.

Method:

A randomized clinical trial study was conducted on 62 patients undergoing radiotherapy. Eligible patients were randomly assigned to the 2 groups. Patients in the footbath group immersed their feet in 41°C water for 20 minutes every night for 2 weeks starting from the seventh day of radiotherapy. Patients in the reflexology group received 20 minutes of foot reflexology every night for 2 weeks starting from the seventh day of radiotherapy. Fatigue was measured by the Multidimensional Fatigue Inventory (MFI) once on the seventh day of radiotherapy and 3 more times on days 7, 14, and 28 after the start of the intervention. Data were analyzed by SPSS20 and descriptive/inferential statistics.

Results:

The total MFI score of both groups declined significantly over time (P < .001). The reflexology group indicated a significant reduction from 90.9 ± 3.2 in the pre-test to 56.0 ± 3.7 on the 28th day in, while the footbath group indicated it from 90 ± 2.6 in the pre-test to 71.4 ± 2.8 on the 28th day.

Conclusion:

Our results showed that foot reflexology and warm footbath reduced the fatigue of patients undergoing radiotherapy. However, foot reflexology was more effective in reducing the fatigue of patients undergoing radiotherapy than warm footbath. It is recommended that simple and low cost non-pharmacological interventions such as foot reflexology to decrease of side effect of radiotherapy among cancer patients should be widely performed.

Trial registration: Iranian Registry of Clinical Trials (IRCT20190625044009N1).

Introduction

According to a 2019 report published by the World Health Organization (WHO), cancer was a leading cause of death before the age of 70 in 112 out of 183 countries studied, and ranked third or fourth in 23 other countries. ¹ Roughly 52% of all cancer patients undergo radiotherapy during their treatment course. ² Radiotherapy involves using gamma rays, X-rays, or accelerated particles to destroy cancer cells ³ and delivers the appropriate amount of radiation for damaging the cancerous tissue while protecting the surrounding healthy tissues. ⁴

Cancer Related Fatigue (CRF), one of the most common side effects of cancer, differs from other types of fatigue in intensity and persistence, and rest and sleep are ineffective on it. Roughly 65% of all cancer patients experience Cancer Related Fatigue, with the rate reaching to 80%-90% among those undergoing radiotherapy. ⁵

Pharmaceutical and non-pharmacological treatments apply to Cancer Related Fatigue, ⁶ but Mustian et al indicated ⁶ that pharmaceutical treatments were less effective than non-pharmacological (exercise and psychological) interventions. ⁷ Patients themselves must practice many non-pharmacological methods to improve their autonomy.^8-10 Non-pharmacological methods have fewer side effects and negative consequences than pharmacological treatments^11,12; the most widely used non-pharmacological methods are hydrotherapy, biofeedback, aromatherapy, meditation, massage, and acupuncture.^13,14

People usually use hydrotherapy for their relaxation and protection of their health. ¹⁵ Warm footbath, one form of hydrotherapy, involves immersing the feet in water at a temperature of 40°C to 43°C for 10 to 30 minutes, ¹⁶ expands the foot vessels to increase blood circulation and timely brings oxygen and nutrients to the brain that are needed to relieve fatigue. ¹⁷ Sharma et al found that footbath with warm water reduced the fatigue of cancer patients undergoing radiotherapy. ¹⁸

Massage is another non-pharmacological intervention for fatigue alleviation. ¹³ Foot reflexology involves applying pressure by fingers, especially the thumb, on certain reflex points in the feet. Reflexologists argue that applying pressure on these reflex points can affect the physiological responses of certain organs. ¹⁹ This therapy increases patient comfort by inducing physiological changes; pressure on the reflexive areas stimulates hundreds of nerve endings in the soles, releases endorphins and consequently prevents pain transfer, causes comfort, decreases tension, and increases tranquility. ²⁰ Tarrasch et al reported that foot reflexology reduced the fatigue of patients with breast cancer during adjuvant radiation therapy. ²¹

Although both warm footbath and foot reflexology are effective in reducing patient’s fatigue, to the best of our knowledge, no study compared the effects of these two interventions on the fatigue of patients undergoing radiotherapy. Therfore, This study aimed to compare the effects of warm footbath and foot reflexology on the fatigue of patients undergoing radiotherapy.

Material and Methods

Study Design and Participants

This randomized clinical trial study was conducted in Mashhad University of Medical Sciences (Mashhad, Iran) in 2019. The study protocol followed the CONSORT criteria as shown in Figure 1. The subjects were recruited among cancer patients undergoing radiotherapy, who stayed in the guest house affiliated to Reza Oncology and Radiotherapy Center, Mashhad, Iran (Figure 1).

Figure 1.

CONSORT diagram for study.

Inclusion and Exclusion Criteria

The inclusion criteria were conscious patients with non-metastatic cancer aged 18 to 60 years, who scored at least 30 points from the Multidimensional Fatigue Inventory (MFI) questionnaire, had a 28-day radiotherapy course, had contact number for follow-up and stayed in the guest house at Reza Oncology and Radiotherapy Center. The exclusion criteria were patients with peripheral vascular thrombosis; Berger’s disease; diabetes; wound or infection in the foot area; decreased peripheral sensation; neurologic conditions due to foot spasms when immersed in water; for example patients with multiple sclerosis who underwent chemotherapy at the same time; the occurrence of a major stressful event; exacerbation of the disease that required special care; postponement of radiotherapy; metastasis confirmed by diagnostic tests; and changes in treatment protocols.

Sample Size

The sample size was estimated based on the results of similar studies using comparison of means, 95% confidence and 80% test power, so the sample size was calculated to be 29 per group, but ultimately 34 patients were recruited into each group to account for possible dropout rate. Four participants in the footbath group left the study because of exacerbation of their disease and 2 in the reflexology group left the study because of the postponement of radiotherapy, so 62 people, 30 in the footbath group and 32 in the reflexology group, remained in the study (Figure 1).

Randomization

Eligible patients were randomly allocated to the footbath and reflexology groups through drawing random sequences (generated by a randomization website).

Outcome Measures

The primary outcome was the cancer patients’ fatigue which was assessed using the Multidimensional Fatigue Inventory (MFI) scale. A demographic questionnaire was used to collect information about demographic characteristics and disease history of patients (age, gender, marital status, and type of cancer). Since the demographic questionnaire and the informed consent form consisted of clear straight forward questions frequently used in research, this questionnaire was completed with the data collected during interviews or from the medical files of patients. The Multidimensional Fatigue Inventory (MFI) measures fatigue with 20 items in 5 dimensions: General Fatigue (4 items), Physical Fatigue (4 items), Reduced Activity (4 items), Reduced Motivation (4 items), and Mental Fatigue (4 items). ²² The items of the MFI are scored on a 5-point Likert scale from 1 (=yes, it is true) to 5 (=no, it is not true), with items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19 rated in reverse. The total score of each dimension ranges from 4 to 20. The total MFI score, obtained by summing the scores of its 5 dimensions, ranges from 20 to 100, with higher scores indicating more fatigue. ²² The validity and reliability of the Persian version of the Modified Fatigue Impact Scale (MFIS) questionnaire for Iranian patients previously was done in study by Ghajarzadeh et al. ²³ In our study the validity of the Persian version of MFI were reassessed and approved using content validity by 10 faculty members of Mashhad University of Medical Sciences. They had PhD degrees in nursing and were experts in the field of education and care of cancer patients undergoing radiotherapy, as well as specialists in complementary medicine for cancer patients. In our study the reliability of the Persian version of MFI was calculated to be 0.86 by test-retest with 10 people. Patients completed MFI on the seventh day of radiotherapy (as pre-test) and the 7th, 14th, and 28th days after the start of the intervention (as post-test).

Footbath Group

The patients in footbath group immersed their feet up to 10 cm into water inside a 40 × 27 × 45 cm plastic container (Limon brand, model 3 made in Iran) at a temperature of 41°C to 42°C for 20 minutes every night 1 hour before the usual bedtime ²⁴ (between 21:00 and 22:00) starting from the seventh day of radiotherapy, for 2 weeks. ¹³ The water temperature was measured by the researcher with a thermometer (TROTEC brand, model BT20 made in Germany).

Reflexology Group

The patients in foot reflexology group were massaged with olive oil (Ghonche brand, refined model made in Iran) for 20 minutes (10 minutes each foot) every night starting from the seventh day of radiotherapy for 2 weeks. Reflexology was performed under supervision of complementary medicine consultan by a researcher who received a certificate after completing 30-hour theoretical and practical training. The researcher massaged the area connected to the first metatarsal bone and the solar plexus and the areas connected to the toe, pituitary and pineal glands. Each foot was massaged for 10 minutes (1 minute of general foot massage and then 3 minutes of massage for each area). Five basic massage techniques were used: effleurage (circular stroking movements), petrissage (kneading movements), friction (rubbing strokes), vibration (shaking movements to loosen the body), and tapotement (tapping). Creating pressure in the reflex areas of the foot during illness leads to the breaking of calcium and uric acid crystals accumulated in the nerve terminals and it releases blocked energy pathways throughout the body; it also improves blood flow throughout the body. ²⁵ The applied pressure was kept at 4 to 5 kg by asking the researcher to calibrate the hand pressure with a digital scale every night before the intervention. The researcher sat on a chair at the bottom of the bed and asked the patient to lie in the supine position to have full access to the soles of both feet. The researcher removed all hand accessories (watches, rings, bracelets, etc.) and trimmed her nails.

Data Collection

Before sampling, permission was obtained from the research ethics committee of Mashhad University of Medical Sciences (IR.MUMS.NURSE.REC.1398.022). To start sampling, we submitted an official letter of introduction issued by the School of Nursing and Midwifery of Mashhad University of Medical Sciences to Reza Radiotherapy and Oncology Center. After gaining permission and coordinating with the center’s head and matron, and head of the guest house, the researcher attended the guest house to recruit interested patients.

Data Analysis

Statistical analyses were performed using SPSS20 (IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp); descriptive statistics (frequency distribution, mean, standard deviation) were used to describe and summarize data, while inferential statistics, including chi-square test, exact chi square, independent t-test, Mann-Whitney test, and repeated-measures ANOVA were used to test the hypothesis. The normality of quantitative variables was checked by Kolmogorov-Smirnov and Shapiro-Wilk tests. All statistical tests were conducted at a confidence level of 95% and a significance level of P < .05.

Results

Patients’ Demographic Characteristics

The mean ages of patients in the reflexology and footbath groups were 44.3 ± 10.9 and 46.9 ± 9.5 years, respectively. Fifty-nine point four percent of patients (N = 19) in the reflexology group and 46.7% (14 people) of patients in the footbath group were women. Statistical tests showed that the 2 groups were homogeneous in terms of age, gender, marital status, and type of cancer (P < .05) (Table 1).

Table 1.

Sociodemographic Characteristics of the Patients.

Characteristics		Group		P value
		Reflexology	Footbath
Average Age (year)		X ± SD	X ± SD	P = .327*
		44.34 ± 10.91	46.93 ± 9.51
		N (%)	N (%)
Gender	Male	13 (40.6)	16 (53.3)	P = .316**
	Female	19 (59.4)	14 (46.7)
Marital Status	Single	10 (31.2)	8 (26.7)	P = .846***
	Married	22 (68.8)	22 (73.3)
Type of cancer	Breast	13 (40.6)	7 (23.3)	P = .752***
	Lung	7 (21.9)	8 (26.7)
	Digestive system	9 (28.2)	13 (43.3)
	Bladder	2 (6.3)	2 (6.7)
	Gynecologic	1 (3.1)	0 (0.0)

^*Independent t-test. **Chi-square. ***Exact chi-square.

Primary Outcomes

As shown in Table 2, we found no significant difference in the total MFI score or the scores of its dimensions between the 2 groups at the pre-test stage (P < .05), but all of these scores were significantly lower in the reflexology group than in the footbath group at the post-test stage (P < .05), except for the score of the Reduced Activity dimension on day 7. The total MFI score and the scores of its dimensions significantly decreased in both groups from pre-test to post-test. The repeated-measures ANOVA showed a significant reduction in the total MFI score and the scores of its dimensions in both groups over time (from before the intervention to 7, 14, and 28 days after the intervention), with the reduction being more pronounced in the reflexology group (P < .001), suggesting that reflexology was more effective in reducing fatigue than footbath (Table 2).

Table 2.

Intragroup and Intergroup Comparisons of the Patients’ Fatigue Score Averages.

Fatigue	TimeGroup	Before	Day 7	Day 14	Day 28	P value**
						Time	Group	Time-Group
Total score	Reflexology	90.9 ± 3.2	87.0 ± 2.3	72.2 ± 2.7	56.0 ± 3.7	P < .001	P < .001	P < .001
	Footbath	90.0 ± 2.6	91.0 ± 2.4	80.6 ± 3.2	71.4 ± 2.6
	P value*	P = .223	P < .001	P < .001	P < .001
General fatigue	Reflexology	18.2 ± 1.0	17.9 ± 0.7	14.3 ± 1.4	11.0 ± 1.6	P < .001	P < .001	P < .001
	Footbath	18.1 ± 0.7	18.4 ± 0.9	16.1 ± 1.4	14.7 ± 1.2
	P value*	P = .711	P = .033	P < .001	P < .001
Physical fatigue	Reflexology	18.6 ± 1.2	17.9 ± 0.8	14.9 ± 1.5	11.5 ± 1.8	P < .001	P < .001	P < .001
	Footbath	18.0 ± 0.9	18.5 ± 1.1	16.9 ± 1.2	14.1 ± 1.5
	P value*	P = .048	P = .024	P < .001	P < .001
Reduced activity	Reflexology	19.0 ± 1.0	18.2 ± 1.0	16.1 ± 0.9	12.9 ± 1.5	P < .001	P < .001	P < .001
	Footbath	18.5 ± 0.8	18.5 ± 0.7	18.0 ± 1.0	15.6 ± 1.5
	P value*	P = .070	P = .183	P < .001	P < .001
Reduced motivation	Reflexology	16.9 ± 1.2	16.0 ± 1.1	12.9 ± 1.9	10.1 ± 1.1	P < .001	P < .001	P < .001
	Footbath	16.9 ± 1.7	17.0 ± 1.3	14.0 ± 1.9	13.5 ± 1.2
	P value*	P = .940	P = .003	P = .028	P < .001
Mental fatigue	Reflexology	18.1 ± 1.0	17.7 ± 1.4	13.8 ± 1.9	10.4 ± 1.7	P < .001	P < .001	P < .001
	Footbath	18.3 ± 0.8	18.4 ± 1.0	15.4 ± 1.1	13.4 ± 1.4
	P value*	P = .383	P = .036	P < .001	P < .001

^*Independent t-test. **Repeated-measures ANOVA.

Discussion

This study aimed to compare the effects of warm footbath and foot reflexology on the fatigue of patients undergoing radiotherapy. The pre-test measurement showed that patients in both groups experienced a high level of fatigue, while the post-test measurement showed that both interventions could alleviate the fatigue of these patients. We found that foot reflexology was more effective in reducing fatigue than warm footbath. Since this is the first study to compare the effects of warm footbath and foot reflexology on the fatigue of patients undergoing radiotherapy, we discuss our results alongside the findings of related studies in the field.

We indicated a 38-point reduction in the fatigue of patients 28 days after foot reflexology (compared to the pre-test). Tarrasch et al found that reflexology reduced the fatigue of patients with breast cancer undergoing radiotherapy ²¹ ; Dikmen and Terzioglu reported that reflexology reduced the fatigue of women with gynecological cancer undergoing chemotherapy. ²⁶ Rambod et al showed the positive impact of foot reflexology on fatigue of patients with lymphoma. ²⁷ There are studies of the positive impact of reflexology on the fatigue of patients suffering from other diseases; Unal ²⁸ and Polat and Ergüney ²⁹ reported fatigue alleviation following reflexology in patients under hemodialysis and patients with COPD. It is believed that reflexology triggers endorphin release, induces a feeling of relaxation and well-being, improves blood flow and endothelial function, ³⁰ and reduces stress and anxiety. ²⁷ Therefore, it is reasonable to argue that reflexology can reduce the fatigue of cancer patients by improving their blood circulation and reducing their stress and anxiety.

 In this study, patients in the warm footbath group experienced a 21-percent fatigue reduction 28 days after this intervention (compared to the pre-test). Sharma et al found that warm footbath reduced the fatigue of cancer patients undergoing radiotherapy, ¹⁸ while Shafeik et al reported that footbath reduced the fatigue of patients under hemodialysis. ¹⁷ Son and Yoo ³¹ and Choi and Song ³² reported the positive effect of warm footbath on fatigue of patients with a stroke and postpartum women, respectively.

Conclusion

Our results showed that foot reflexology and warm footbath reduced the fatigue of patients undergoing radiotherapy. Comparing the mean (SD) fatigue scores indicated that foot reflexology was more effective on fatigue alleviation for these patients. Fatigue is one of the most common complaints of patients undergoing radiotherapy and its implications can directly affect a patient’s life style and quality of life, so we recommend the independent or combined use of foot reflexology and warm footbath to reduce fatigue in cancer patients undergoing radiotherapy. This study had several limitations: the sample size was small; which makes it difficult to generalize results to all patients. We conducted this study only on cancer patients undergoing radiotherapy, so the results can only be generalizable to this group of patients. We were unable to control other factors that might have influenced patients’ fatigue.