Clinical trial NCT05668247: The Effects on Sleep qualıty and fatıgue Level of Foot Bath
Official title: The Effects on Sleep Quality and Fatıgue Level of Foot Bath Made in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
fatigue
foot bath
nursing
sleep quality
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2022-12-29
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aims and objectives: To determine the effect of foot bath on sleep quality and fatigue level in patients with chronic obstructive pulmonary disease (COPD).

Background: İnsomnia and fatigue are one of the most common symptoms in people with COPD and adversely affects their activities of daily living.

Design: This study was conducted as a nonrandomized controlled trial. Methods:The study sample comprised 70 patients who met the inclusion criteria.Data were collected with Patient Information Form, Pittsburgh Sleep Quality Index and Piper Fatigue Scale. Intervention group; The 30-day foot bath was administered for 10 minutes before bedtime, while no control was performed in the control group. The Pittsburgh Sleep Quality Index (PUKI) and the Piper Fatigue Scale were administered in both groups at the beginning of the service (first follow-up) and four weeks later (second follow-up) at the outpatient clinic.

Conclusions: The foot bath by individuals with COPD was determined to significantly improve the participants'levels sleep quality and fatigue.

Detailed description: The physical symptoms frequently seen in COPD patients and adversely affecting routine life are dyspnoea, cough, phlegm, malnourishment/loss of appetite, nausea-vomiting, constipation, dehydration, sleeplessness, weakness/fatigue, delirium, anxiety, and depression.

It has been stated that the patients who experience severe symptoms cannot sleep, this condition impairs their sleep quality and they feel fatigue all day long. It has been observed in the literature that there are a decrease in sleep efficiency and total sleep duration, an increase in sleep latency, falling asleep late, and waking up, and a decrease in non-rapid eye movement (NREM) sleep and rapid eye movement (REM) sleep among COPD patients especially due to the cough and respiratory distress symptoms.

1.2 Literature review The qualitative aspects of sleep include sleep duration, sleep latency and the number of awakening during the night; on the other hand, its subjective aspects include elements such as sleep depth and relaxation. It is important to assess these elements in order to assess the sleep quality of patients.

Just like the sleep problems, fatigue is also an important problem seen in patients with COPD. In the studies, it has been determined that the patients with COPD have different levels of fatigue and their mental, physical and social functions may be affected from fatigue.

It is thought that the most common symptom in patients with chronic obstructive pulmonary disease (COPD) is dyspnoea. However, it has been reported that fatigue is observed in the patients as frequent as respiratory distress. Fatigue is the main factor restricting the exercise tolerance of the individuals. A positive significant correlation has been determined between fatigue and dyspnoea. Fatigue affects the realisation of activities of daily living negatively and impairs quality of life as it reduces activity tolerance of patients.

Decreased effect of the pharmacological methods mostly preferred to solve sleep problems, the side effects of drugs, and the necessity of using drugs continuously have led people to use non-pharmacological methods. These methods include the complementary and integrative practices such as yoga, aromatherapy, massage, energy therapy, music therapy, reflexology, acupuncture, and acupressure. In recent years, many complementary and integrative methods have come into use as the number of studies on eliminating sleep problems and enhancing sleep quality has increased. One of these methods is hot foot bath. It is stated that hot foot bath provides a relaxing body temperature by regulating blood circulation, keeping feet in hot water relaxes the whole body, reduces fatigue and makes sleeping easier and, therefore, it is a therapeutic technique frequently used in nursing.

Important tasks of nurses include preparing the suitable environment for the patients to take a rest and providing to fulfil the basic physiological needs such as sleep etc. to enable the human body to continue its existence. For this reason, determining the factors preventing the patients from sleeping well in the hospital environment and eliminating these factors are of prime importance. Nurses who are the members of the healthcare team should solve the problems caused by sleeplessness and prevent the fatigue problem that may be caused by sleeplessness.

This study was conducted to examine the effect of the hot foot bath on sleep quality and fatigue level of the individuals with COPD.

The hypotheses of the study were as follows:

H1: The foot bath applied with hot water at 38-40°C for 10 minutes before going to sleep for 30 days is effective in enhancing sleep quality of the individuals staying in the hospital and receiving COPD treatment.

H2: The foot bath applied with hot water at 38-40°C for 10 minutes before going to sleep for 30 days is effective in decreasing fatigue level of the individuals staying in the hospital and receiving COPD treatment.

Eligibility criteria: Inclusion Criteria:

The patients,

* who were diagnosed with COPD,
* were aged between 55-85 years,
* did not have a psychiatric disease requiring treatment,
* had no diagnosed sleep disorder,
* had orientation to person, place, and time, can be communicated verbally,
* had a general state of health enough to perceive the questions in the questionnaire and answer them correctly,
* had a mild (FEV1 ≥ 80%) and moderate (50% ≤ FEV1 \< 80%) COPD stage,
* agreed to participate in the study were included in the study.

Exclusion Criteria:

The patients,

* who had Diabetes Mellitus (DM), CVA, CHF, coronary artery disease, coagulation disorders such as varicosity, deep vein thrombosis and disseminated intravascular coagulation,
* were using CPAP (Continuous Positive Airway Pressure) and BIPAP (Bi-level Positive Airway Pressure) devices,
* were diagnosed with sleep disorder,
* had the general condition disorder developed related to diagnosis within the application and control process were excluded from the study.

Primary outcomes:
measure: Hypotes 1
timeFrame: Ahrough study completion, an average of 1 year
measure: Hypotes 2
timeFrame: hrough study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Sevil Şahin
Study officials:
References: