- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04413188
A Warm Foot Bath, Sleep Quality and Comfort Level
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 65 years and up
- relative independent in daily life activities
- literate
- having a PSQI score of 5 or more
- no communication problems.
Exclusion Criteria:
- who used sleeping drugs or diuretic drugs
- had peripheral artery diseases
- neurological diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A warm foot bath group
65years, relative independent in daily life activities and literate, having a PSQI score of 5 or more and no communication problems.
|
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.
|
NO_INTERVENTION: Control group
65years, relative independent in daily life activities and literate, having a PSQI score of 5 or more and no communication problems.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
before applying the first foot bath
|
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
|
six weeks after the first foot bath
|
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.
|
six weeks after the first foot bath
|
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.
|
Daily for six weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hanife Durgun, Dr, Ordu State Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HanifeB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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