Older PeopleNCT04413188
A Warm Foot Bath, Sleep Quality and Comfort Level
A study testing Warm foot bath in people with Older People and Sleep Problems, run by Ordu University.
Trial summary
Objectives: To determine the effectiveness of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems. Design and methods: This study was a randomized controlled trial. A total of 217 elderly individual who stayed in two nursing homes. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older People, Sleep Problems
- What is being tested?
- Warm foot bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 31 May 2017
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years and up
- relative independent in daily life activities
- literate
- having a PSQI score of 5 or more
- no communication problems.
Who cannot join
- who used sleeping drugs or diuretic drugs
- had peripheral artery diseases
- neurological diseases.
About this study
Official title: Effect of Warm Foot Bath on Their Sleep Quality and Comfort Level in Elderly Individuals: A Randomized-controlled Trial
Objectives: To determine the effectiveness of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems.
Design and methods: This study was a randomized controlled trial. A total of 217 elderly individual who stayed in two nursing homes. The sample consisted of 60 elderly individuals with sleep problem who were randomly assigned to either the warm foot bath group (n= 30) and control group (n=30).The study was completed with 60 elderly individuals. The primary outcome was an information questionnaire, the Pittsburgh Sleep Quality Index, the General Comfort Questionnaire and the Numerical Rating Scale.
Read the detailed description
The age pyramid of the world population is changing, and as it does so, the percentage of elderly people is rapidly increasing. As one advances in age, it has been found that they tend to sleep latency later, have reduced time spent within crucial rapid eye movement (REM) sleep, and have reduced total duration and quality of sleep and sleep-related problems start to occur. The National Sleep Foundation The national sleep federation recommends 7-8 hours of sleep per day for the elderly. However, many elderly report that they sleep less than recommended and have difficulty sleep latency.
Sleeping is a significant action that affects individuals' daily lives as well as their quality of life. Sleep is required to meet the basic needs of daily life and comprises physiological, psychological, environmental and sociocultural dimensions. Sleep quality, which has been considered as increasingly significant in recent years, can be defined as feeling physically-fit, refreshed, and ready for a new day when waking up. Sleep quality consists of several quantitative aspects and measurements of sleep itself, such as the duration before sleep latency, the duration of sleep, the number of times a person wakes up in the night, as well as more subjective aspects such as the depth of sleep and the relaxing characteristic of sleep.
Such sleep-related problems may negatively affect an individual's comfort. Comfort is a basic need that comprises one of the cornerstones of holistic nursing care practice. Accordingly, solving sleep-related problems, increasing sleep quality, and ensuring comfort for the individuals concerned will require comprehensive nursing care. Pharmacological methods are the most commonly used approach in trying to resolve sleep-related problems. However, these methods have been insufficient as they do not provide a complete solution for sleep-related problems. Additionally, the side effects of these methods, which are obligatory for the affected individuals, are numerous, and this has paved the way for the development of non-pharmacological treatment methods. Relevant literature indicates methods such as eye masks, music therapy, massages, alternative and supplementary therapies, aromatherapy, and warm foot bath have all been successfully used to solve sleep-related problems among elderly people, thereby boosting their sleep quality and comfort.
Warm foot bath causes peripheral vasodilation and decreases core body temperatures. A negative relationship was found between core body temperature and inclination to sleep. Individuals' sleep latency decreases when body core temperature decreases thus, individuals' sleep quality and comfort level are increased. Warm foot bath as a non-pharmacological methods is a more practical and less expensive approach when compared with others.
The relevant literature demonstrated that the number of studies examining sleep quality and comfort among elderly people was limited. The literature included some studies that examined the use of relaxation exercises, back-massage practices, aromatherapy, and music therapy to improve sleep quality and comfort. However, the number of studies examining the effect of warm foot bath on sleep quality was found to be limited . The purpose of the trial was to investigate the effect of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems. Our primary hypothesis was that the sleep quality of the intervention group would be better after 6 weeks than the control group. The secondary hypotheses were that the comfort levels of the intervention group would be better after 6 weeks than the control group
- Conditions
- Older People, Sleep Problems
- Being tested
- Warm foot bath
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm foot bathOther
The participants in experimental group were asked to soak their feet in warm water (38-40°C) for 20 minutes one hour before their bedtimes for six weeks. A special foot bath (Beurer FB50 luxury foot bath spa with water heater) was used for this purpose. The bath is 10 cm deep; it keeps water at a constant temperature of 35-48°C for 15-60 minutes, has a display screen for water temperature and duration of use, and turns off automatically.
| Study group | Role | What they receive |
|---|---|---|
| A warm foot bath group | Experimental | 65years, relative independent in daily life activities and literate, having a PSQI score of 5 or more and no communication problems. Receives: Other: Warm foot bath |
| Control group | No intervention | 65years, relative independent in daily life activities and literate, having a PSQI score of 5 or more and no communication problems. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) This index was developed by Buysse and colleagues to evaluate individuals' sleep quality and sleeping disorders over a month. The scale consists of 24 items, 19 of these items are related to self-reporting and are answered by the respondents. This is composed of 19 questions which reflect seven major components. The last five items of the index (11a, 11b, 11c, 11d, and 11e) are answered by the partners or roommates of the participants, and these items are not included in the scoring. Each item is scored with points ranging from 0 to 3, with 0 indicating a "good" score and 3 indicating a "poor" score. Accordingly, higher total scores indicate poor sleep quality; scores of 0-4 indicate good sleep quality, and scores of 5-21 suggest poor sleep quality
Measured: before applying the first foot bath
Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) This index was developed by Buysse and colleagues to evaluate individuals' sleep quality and sleeping disorders over a month. The scale consists of 24 items, 19 of these items are related to self-reporting and are answered by the respondents. This is composed of 19 questions which reflect seven major components. The last five items of the index (11a, 11b, 11c, 11d, and 11e) are answered by the partners or roommates of the participants, and these items are not included in the scoring. Each item is scored with points ranging from 0 to 3, with 0 indicating a "good" score and 3 indicating a "poor" score. Accordingly, higher total scores indicate poor sleep quality; scores of 0-4 indicate good sleep quality, and scores of 5-21 suggest poor sleep quality
Measured: six weeks after the first foot bath
Comfort level
The General Comfort Questionnaire (GCQ) This questionnaire was developed by Katharine Kolcaba in 1992 to determine individuals' comfort needs and evaluate nursing interventions that might be employed to ensure and increase such comfort. The GCQ uses a four-point Likert type scale and consists of 48 items. The lowest score that can be obtained from the scale is 48, the highest score is 192. The total score obtained from the scale was divided by 48 (the number of the items in the scale) to determine the score's mean value which was presented as a score between one and four. The GCQ was adapted for use in a Turkish context by Kuguoğlu and Karabacak in 2004. The Cronbach's alpha coefficient of the original scale was 0.88; in the study by Kuguoglu and Karabacak, it was 0.85. The present study derived a Cronbach's alpha coefficient of 0.68 prior to experimental and 0.75 after experimental.
Measured: six weeks after the first foot bath
Dailiy sleep quality: The Numerical Rating Scale (NRS)
The Numerical Rating Scale (NRS) This scale was prepared as a form incorporating a scale; it was then used by individuals who were able to mark and assess their personal sleep quality each day. The NRS asks patients to choose the number from 0 to 10 that best represents their sleep with 0 representing a poor night's sleep, and 10 representing a good night's sleep.
Measured: Daily for six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Dec 2016
- Primary completion31 Jan 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trail
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanife DURGUN, Ordu University
- Investigators
- Hanife Durgun, Dr, Principal investigator, Ordu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413188
- Sponsor's protocol ID
- HanifeB
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 2 Jun 2020
- 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 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Warm Foot Bath on Their Sleep Quality and Comfort Level in Elderly Individuals: A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04413188
- Acronym / sponsor ID
- HanifeB
- Conditions
- Older People, Sleep Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 2 Jun 2020 (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.
Objectives: To determine the effectiveness of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems.
Design and methods: This study was a randomized controlled trial. A total of 217 elderly individual who stayed in two nursing homes. The sample consisted of 60 elderly individuals with sleep problem who were randomly assigned to either the warm foot bath group (n= 30) and control group (n=30).The study was completed with 60 elderly individuals. The primary outcome was an information questionnaire, the Pittsburgh Sleep Quality Index, the General Comfort Questionnaire and the Numerical Rating Scale.
Detailed description
The age pyramid of the world population is changing, and as it does so, the percentage of elderly people is rapidly increasing. As one advances in age, it has been found that they tend to sleep latency later, have reduced time spent within crucial rapid eye movement (REM) sleep, and have reduced total duration and quality of sleep and sleep-related problems start to occur. The National Sleep Foundation The national sleep federation recommends 7-8 hours of sleep per day for the elderly. However, many elderly report that they sleep less than recommended and have difficulty sleep latency.
Sleeping is a significant action that affects individuals' daily lives as well as their quality of life. Sleep is required to meet the basic needs of daily life and comprises physiological, psychological, environmental and sociocultural dimensions. Sleep quality, which has been considered as increasingly significant in recent years, can be defined as feeling physically-fit, refreshed, and ready for a new day when waking up. Sleep quality consists of several quantitative aspects and measurements of sleep itself, such as the duration before sleep latency, the duration of sleep, the number of times a person wakes up in the night, as well as more subjective aspects such as the depth of sleep and the relaxing characteristic of sleep.
Such sleep-related problems may negatively affect an individual's comfort. Comfort is a basic need that comprises one of the cornerstones of holistic nursing care practice. Accordingly, solving sleep-related problems, increasing sleep quality, and ensuring comfort for the individuals concerned will require comprehensive nursing care. Pharmacological methods are the most commonly used approach in trying to resolve sleep-related problems. However, these methods have been insufficient as they do not provide a complete solution for sleep-related problems. Additionally, the side effects of these methods, which are obligatory for the affected individuals, are numerous, and this has paved the way for the development of non-pharmacological treatment methods. Relevant literature indicates methods such as eye masks, music therapy, massages, alternative and supplementary therapies, aromatherapy, and warm foot bath have all been successfully used to solve sleep-related problems among elderly people, thereby boosting their sleep quality and comfort.
Warm foot bath causes peripheral vasodilation and decreases core body temperatures. A negative relationship was found between core body temperature and inclination to sleep. Individuals' sleep latency decreases when body core temperature decreases thus, individuals' sleep quality and comfort level are increased. Warm foot bath as a non-pharmacological methods is a more practical and less expensive approach when compared with others.
The relevant literature demonstrated that the number of studies examining sleep quality and comfort among elderly people was limited. The literature included some studies that examined the use of relaxation exercises, back-massage practices, aromatherapy, and music therapy to improve sleep quality and comfort. However, the number of studies examining the effect of warm foot bath on sleep quality was found to be limited . The purpose of the trial was to investigate the effect of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems. Our primary hypothesis was that the sleep quality of the intervention group would be better after 6 weeks than the control group. The secondary hypotheses were that the comfort levels of the intervention group would be better after 6 weeks than the control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomized controlled trail
| Arm | Type | Receives |
|---|---|---|
| A warm foot bath group | Experimental | Other: Warm foot bath65years, relative independent in daily life activities and literate, having a PSQI score of 5 or more and no communication problems. |
| Control group | No intervention | –65years, relative independent in daily life activities and literate, having a PSQI score of 5 or more and no communication problems. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 years and up
- relative independent in daily life activities
- literate
- having a PSQI score of 5 or more
- no communication problems.
Key exclusion criteria (3 listed)
- who used sleeping drugs or diuretic drugs
- had peripheral artery diseases
- neurological diseases.
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 |
|---|---|---|
| Warm foot bathThe participants in experimental group were asked to soak their feet in warm water (38-40°C) for 20 minutes one hour before their bedtimes for six weeks. A special foot bath (Beurer FB50 luxury foot bath spa with water heater) was used for this purpose. The bath is 10 cm deep; it keeps water at a constant temperature of 35-48°C for 15-60 minutes, has a display screen for water temperature and duration of use, and turns off automatically. | Other | A warm foot bath group |
Primary outcome
Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Time frame: before applying the first foot bath
The Pittsburgh Sleep Quality Index (PSQI) This index was developed by Buysse and colleagues to evaluate individuals' sleep quality and sleeping disorders over a month. The scale consists of 24 items, 19 of these items are related to self-reporting and are answered by the respondents. This is composed of 19 questions which reflect seven major components. The last five items of the index (11a, 11b, 11c, 11d, and 11e) are answered by the partners or roommates of the participants, and these items are not included in the scoring. Each item is scored with points ranging from 0 to 3, with 0 indicating a "good" score and 3 indicating a "poor" score. Accordingly, higher total scores indicate poor sleep quality; scores of 0-4 indicate good sleep quality, and scores of 5-21 suggest poor sleep quality
Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Time frame: six weeks after the first foot bath
The Pittsburgh Sleep Quality Index (PSQI) This index was developed by Buysse and colleagues to evaluate individuals' sleep quality and sleeping disorders over a month. The scale consists of 24 items, 19 of these items are related to self-reporting and are answered by the respondents. This is composed of 19 questions which reflect seven major components. The last five items of the index (11a, 11b, 11c, 11d, and 11e) are answered by the partners or roommates of the participants, and these items are not included in the scoring. Each item is scored with points ranging from 0 to 3, with 0 indicating a "good" score and 3 indicating a "poor" score. Accordingly, higher total scores indicate poor sleep quality; scores of 0-4 indicate good sleep quality, and scores of 5-21 suggest poor sleep quality
Comfort level
Time frame: six weeks after the first foot bath
The General Comfort Questionnaire (GCQ) This questionnaire was developed by Katharine Kolcaba in 1992 to determine individuals' comfort needs and evaluate nursing interventions that might be employed to ensure and increase such comfort. The GCQ uses a four-point Likert type scale and consists of 48 items. The lowest score that can be obtained from the scale is 48, the highest score is 192. The total score obtained from the scale was divided by 48 (the number of the items in the scale) to determine the score's mean value which was presented as a score between one and four. The GCQ was adapted for use in a Turkish context by Kuguoğlu and Karabacak in 2004. The Cronbach's alpha coefficient of the original scale was 0.88; in the study by Kuguoglu and Karabacak, it was 0.85. The present study derived a Cronbach's alpha coefficient of 0.68 prior to experimental and 0.75 after experimental.
Dailiy sleep quality: The Numerical Rating Scale (NRS)
Time frame: Daily for six weeks
The Numerical Rating Scale (NRS) This scale was prepared as a form incorporating a scale; it was then used by individuals who were able to mark and assess their personal sleep quality each day. The NRS asks patients to choose the number from 0 to 10 that best represents their sleep with 0 representing a poor night's sleep, and 10 representing a good night's sleep.
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 2 Jun 2020.
- 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.
Hanife Durgun, Dr principal investigator
Ordu State Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Warm foot bath in people with Older People and Sleep Problems, run by Ordu University.
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 5 inclusion and 3 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 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Sleep quality: Pittsburgh Sleep Quality Index (PSQI) (time frame: before applying the first foot bath). The study lists 4 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 2 Jun 2020.