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The Effects on Sleep qualıty and fatıgue Level of Foot Bath

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
FOOT BATH
Sponsored by
Sevil Şahin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, fatigue, foot bath, nursing, sleep quality

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sevil Şahin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

foot bath is a type of relaxation and care performed by putting feet in water. Feet, as the organs carrying the whole body weight are the body parts where fatigue is felt most. In this study, a specially designed foot bath bucket was used in order to apply foot bath for the patients in the experimental group. The bucket has a five-level water heating system (35-48 °C). It has a magnetic field and operates at 390 Watt. It has a splash shield. There are non-slip rubber legs on its bottom. it has heat protection feature for thermal insulation as it has a two-walled structure

On the first day (the first follow-up), Patient Information Form, PSQI (ANNEX-II) and Piper Fatigue Scale were applied to the patients in the control group whose consent was obtained in the first follow-up, through face-to-face interview. At the end of the 30th day (the second follow-up), PSQI and Piper Fatigue Scale were applied again to the patients who came for the outpatient clinic control. The routine treatment of the control group was not interfered and no intervention was performed.

Outcomes

Primary Outcome Measures

Hypotes 1
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.
Hypotes 2
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.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
December 20, 2022
Sponsor
Sevil Şahin
Collaborators
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT05668247
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
April 5, 2018 (Actual)
Study Completion Date
April 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sevil Şahin
Collaborators
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, fatigue, foot bath, nursing, sleep quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
foot bath is a type of relaxation and care performed by putting feet in water. Feet, as the organs carrying the whole body weight are the body parts where fatigue is felt most. In this study, a specially designed foot bath bucket was used in order to apply foot bath for the patients in the experimental group. The bucket has a five-level water heating system (35-48 °C). It has a magnetic field and operates at 390 Watt. It has a splash shield. There are non-slip rubber legs on its bottom. it has heat protection feature for thermal insulation as it has a two-walled structure
Arm Title
Control
Arm Type
No Intervention
Arm Description
On the first day (the first follow-up), Patient Information Form, PSQI (ANNEX-II) and Piper Fatigue Scale were applied to the patients in the control group whose consent was obtained in the first follow-up, through face-to-face interview. At the end of the 30th day (the second follow-up), PSQI and Piper Fatigue Scale were applied again to the patients who came for the outpatient clinic control. The routine treatment of the control group was not interfered and no intervention was performed.
Intervention Type
Other
Intervention Name(s)
FOOT BATH
Intervention Description
In general, foot bath is a type of relaxation and care performed by putting feet in water. Feet, as the organs carrying the whole body weight are the body parts where fatigue is felt most. In this study, a specially designed foot bath bucket was used in order to apply foot bath for the patients in the experimental group.
Primary Outcome Measure Information:
Title
Hypotes 1
Description
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.
Time Frame
Ahrough study completion, an average of 1 year
Title
Hypotes 2
Description
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.
Time Frame
hrough study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Sevil Şahin
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects on Sleep qualıty and fatıgue Level of Foot Bath

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