Chronic Obstructive Pulmonary DiseaseNCT05668247
The Effects on Sleep qualıty and fatıgue Level of Foot Bath
A study testing FOOT BATH in people with Chronic Obstructive Pulmonary Disease, run by Sevil Şahin at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- FOOT BATH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2017to 5 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects on Sleep Quality and Fatıgue Level of Foot Bath Made in Patients With Chronic Obstructive Pulmonary Disease
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.
Read more
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- FOOT BATH
- Keywords
- COPD, fatigue, foot bath, nursing, sleep quality
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Fatigue, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOOT BATHOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Other: FOOT BATH |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Ahrough study completion, an average of 1 year
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.
Measured: hrough study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start5 May 2017
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sevil Şahin
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Sponsor-investigator, Sevil Şahin, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668247
- Sponsor's protocol ID
- 2017/370
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Sleep Quality and Fatıgue Level of Foot Bath Made in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05668247
- Acronym / sponsor ID
- 2017/370
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, fatigue, foot bath, nursing, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sevil ŞahinUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 5 May 2017 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: FOOT BATHfoot 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 |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOOT BATHIn 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. | Other | Intervention |
Primary outcome
Hypotes 1
Time frame: Ahrough study completion, an average of 1 year
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
Time frame: hrough study completion, an average of 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOOT BATH in people with Chronic Obstructive Pulmonary Disease, run by Sevil Şahin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypotes 1 (time frame: Ahrough study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022; AzTrials last refreshed its copy on 1 Nov 2026.