Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04663178 |
| Other study ID # |
Warm Salt Water Foot Bath |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2017 |
| Est. completion date |
February 28, 2018 |
Study information
| Verified date |
September 2023 |
| Source |
Istanbul University - Cerrahpasa (IUC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: In a limited number of studies conducted with the participation of cancer
patients, it has been reported that warm water bath may be beneficial for management of
cancer-related fatigue.
Objective: This experimental study was conducted to evaluate the effect of warm salt water
foot bath applied to reduce the chemotherapy-induced fatigue.
Interventions/Methods: Seventy-nine patients who were experiencing moderate or higher level
of fatigue were included in this study conducted between November 2017-February 2018. 42 of
the patients were assigned to the experimental group and 37 patients were assigned to the
control group. A training booklet about chemotherapy-induced fatigue were given to all
patients. In addition, the experimental group was asked to perform 20-minute warm salt water
application to their feet for a week after the treatment by explaining and showing the video
prepared about the preparation and practice of warm salt water foot bath. Subsequently, the
patients were called by phone every day for one week to record their fatigue levels.
Results: The 7-day fatigue course of both groups was similar. However the physical,
emotional, affective and cognitive distress related to fatigue decreased in the experimental
group but did not decrease in the control group.
Conclusion: The warm salt water footbath may be an effective approach in enhancing fatigue
related quality of life. However, it is needed to conduct more comprehensive studies to
express the effectiveness.
Implications to Practice: Nurses can propose the use of the warm salt water footbath in the
management of chemotherapy induced fatigue.
Keywords: Chemotherapy Induced Fatigue, Warm salt water foot bath
Description:
Cancer is an important health problem that is seen frequently in the society and causes a
large number of people to lose their lives today. Turkey Statistics Institute's report
stating that 81.129 people living in Turkey lost their lives in 2018 due to cancer has
further increased the importance of this issue.
The main treatment approaches used in the treatment of cancer are surgical treatment,
chemotherapy, and radiotherapy. Being one of these treatment approaches, chemotherapy causes
many side effects such as low blood count, fatigue, alopecia, change in taste/smell,
nausea-vomiting, mucositis, constipation, diarrhoea, loss of appetite, and neuropathy and
adversely affects the quality of life and compliance to treatment. Fatigue, which is one of
these problems, is one of the main problems that is frequently reported by patients and
adversely affects the daily activities of patients. The incidence of fatigue in patients
undergoing chemotherapy has been reported to be 82-96%. Many studies have reported that 30%
of patients continue to experience fatigue feeling even in the post-treatment period. Many
patients have expressed that they have difficulty in performing activities of daily living
and experience difficulty in focusing, lack of strength, apathy towards activities, mood
disorders, and loss of sexual desire due to fatigue. Therefore, extensive examination and
management of fatigue are important to ensure the compliance to treatment in these patients,
increase the treatment efficacy, and enhance their quality of lives.
In the literature, the use of many pharmacological and non-pharmacological approaches in the
management of chemotherapy-induced fatigue is recommended. While pharmacological approaches
such as methylphenidate, modafinil, and erythrocyte transfusion ensure patients to cope with
fatigue by generally treating the problems causing the development of fatigue,
non-pharmacological approaches such as training of the patients as well as their families,
increasing activity level, yoga, Tai-Chi and Reiki practice, cognitive behavioural therapy
approach, energy saving, nutrition regulation, music therapy and massage strengthen patients
and support them to cope with fatigue.
This experimental study was conducted in the Outpatient Chemotherapy Unit of the Institute of
Oncology in Istanbul University between 15 November 2017 and 28 February 2018 after obtaining
institutional permission and ethics committee approval. After giving information about the
study, the patients who agreed to participate in the study were divided into experimental (n
= 38) or control (n = 37) groups using a randomisation list prepared by random number method
in Excel program by the researcher. Interactive training and training booklet containing the
definition, causes, ad development process of chemotherapy-induced fatigue and effective
coping approaches were delivered to both groups. In addition; in order to cope with
chemotherapy-induced fatigue, the experimental group patients were asked 1 day after the
treatment to apply warm salt water bath of 41-42ºC once a day for 20 minutes between
21:00-22:00 at home for 7 days and when chemotherapy related fatigue was at the highest
level. By using 10-minute video previously prepared by the researcher, how the patient will
prepare and apply the temperature of the warm salt water of 41-42oC and the salt rate (280
grams of table salt to 8 litres of water) to be used for footbath were shown and explained.
