ElderlyNCT05572554
The Effect of a Foot Bath on Sleep Quality in The Elderly
A study testing Foot Bath Group in people with Elderly and Sleep Quality, run by Hatice Demirağ, Ph.D at 1 site in Turkey (Türkiye).
Trial summary
This study was carried out as a single-blind randomized controlled study to investigate the effect of a foot bath on sleep quality in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly, Sleep Quality, Complementary Therapy
- What is being tested?
- Foot Bath Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Jul 2022
- 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 to 81 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being 65 years old or older,
- Being literate,
- Performing activities of daily living,
- Not having problems with the sense organs (such as eyes, ears, skin),
- Not being paraplegic/hemiplegic,
- Not working the night shift, and
- Having a mobile phone that can make video a call or having a relative with such a phone.
Who cannot join
- Refusing to participate in the research,
- Having psychological disorders,
- Using complementary therapy to sleep,
- Having enuresis,
- Being bedridden or using a wheelchair, and
- Having more than 10 years of diagnosis of diabetes or diabetes-related neuropathy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gümüşhane University
Gümüşhane, Kelki̇t, 29600
About this study
Official title: The Effect of a Foot Bath on Sleep Quality in The Elderly: A Single-Blind Randomised Controlled Trial
This study was carried out as a single-blind randomized controlled study to investigate the effect of a foot bath on sleep quality in the elderly.
Read the detailed description
Sleep consists of psychological, physiological, and social dimensions and has an extremely significant function in meeting basic human needs. Sleep affects everyone's daily life and quality of life. One of the concepts that have been emphasized and gained importance recently is "sleep quality". Sleep quality is defined as "an individual's feeling ready and energetic for a new day after waking up". It is thought that sleep quality also has quantitative aspects such as falling asleep, sleep duration, number of awakenings at night, and subjective aspects such as restfulness or depth of sleep.
The population of elderly individuals is increasing day by day worldwide. In the changing age pyramid, the rate of elderly population was 9.7 % (8245124 people) (over 65 years of age) in 2021 and is estimated to be 11.0 % in 2025, 12.9 % in 2030, 16.3 % in 2040, 22.6 % in 2060, and 25.6% in 2080. With increasing age, changes occur in normal sleep patterns, complaints of insomnia increase, and satisfaction with sleep quality decreases. According to a literature review, sleep problems rank third among the reasons for visiting a doctor in the elderly, after digestive system problems and headache symptoms. The inability to fall asleep, waking up early in the morning, waking up frequently at night, and sleeping during the day are among the most common sleep-related problems in the elderly.
Sleep problems in the elderly can cause serious problems but are also preventable. In this sense, all health personnel, especially nurses, should apply comprehensive nursing care to minimize sleep problems and improve sleep quality in the elderly. Pharmacological treatment is generally employed in the elimination of sleep problems. However, pharmacological treatment is inadequate in eliminating sleep problems, so the elderly continuously use medication, which can cause side effects. On the other hand, the tendency toward non-pharmacological treatment has recently increased, and developments have been achieved in non-pharmacological treatment methods. It has been reported that methods such as music therapy, eye mask, complementary therapies, massage, aromatherapy, and a foot bath are used to improve the sleep quality of elderly people with sleep problems. Foot baths are reported to facilitate falling asleep by affecting body temperature. Sleep quality may improve in patients whose falling asleep process becomes easier. However, to the best of this knowledge, no study has been found in Turkey in which foot baths are used in the elderly and other populations. After all these considerations, the effect of a foot bath on sleep quality in the elderly was analyzed in this study.
- Conditions
- Elderly, Sleep Quality, Complementary Therapy, Chronic Disease
- Being tested
- Foot Bath Group
- Keywords
- Elderly, Sleep quality, Foot bath, Complementary therapy, Chronic disease
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Bath GroupOther
The elderly were asked to soak their feet in the water in a marked plastic container with a depth of 10 centimeters and a temperature of 41-42°C for 20 minutes up to their ankles 50 minutes before normal sleeping hours every night for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Foot Bath Group | Experimental | This group of elderly people were taught the foot bath practically by a researcher at the pre-study meeting and were given the "Foot Bath Information Brochure" and a "personalized water thermometer". The other researcher administered the "Elderly Information Form" and "PSQI" to all elderly people before the study using individual interviews lasting approximately 15 minutes and pen and paper method. The elderly were asked to soak their feet in the water in a marked plastic container with a depth of 10 centimeters and a temperature of 41-42°C for 20 minutes up to their ankles 50 minutes before normal sleeping hours every night for 8 weeks. In addition, the PSQI, which provides information about sleep quality, type, and severity of sleep disturbance, was applied to the elderly before the study (pretest), 4th week (interim measurement/1st measurement), and at the end of the study (8th week) for a total of 3 times during 8 weeks. Receives: Other: Foot Bath Group |
| Control Group | No intervention | No application was made to the elderly in this group. Only the PSQI, which gives information about sleep quality, type, and severity of sleep disturbance, was administered to the elderly before the study (pretest), at the 4th week (interim measurement/1st measurement), and at the end of the study (8th week) for a total of 3 times for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pittsburgh Sleep Quality Index (PSQI)
PSQI is an index that questions sleep quality, type, and severity of sleep disturbance in the last month in adults. 19 questions are answered by the person himself/herself, and 5 questions are answered by the person's bedmate or people sleeping in the same room.
The PSQI, which provides information about sleep quality, type, and severity of sleep disturbance, was applied to the elderly before the study (pretest), 4th week (interim measurement/1st measurement), and at the end of the study (8th week) for a total of 3 times during 8 weeks.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 May 2022
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample size was calculated as 36 (18 for each group) elderly in total for the two groups (foot bath group, control group) with an effect size of 1,000 and the power of the targeted test was 0.90 (90%) in the G\*Power 3.1.9.6 program with the error of α=0.05 and a reference to a previous study on the subject (14). Considering the cases such as withdrawal from the study or death during the research, each group was increased and a total of 50 elderly individuals, 25 elderly people for each group, were recruited for the study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Demirağ, Ph.D
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatice Demirağ, Ph.D, Karadeniz Technical University
- Investigators
- Hatice Demirağ, Dr.Öğr.Üyesi, Principal investigator, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572554
- Sponsor's protocol ID
- RCS10052022
- Status last verified
- Nov 2023
- First submitted
- 5 Oct 2022
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Foot Bath on Sleep Quality in The Elderly: A Single-Blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05572554
- Acronym / sponsor ID
- RCS10052022
- Conditions
- Elderly, Sleep Quality, Complementary Therapy, Chronic Disease
- Keywords
- Elderly, Sleep quality, Foot bath, Complementary therapy, Chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hatice Demirağ, Ph.DUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 7 Oct 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.
This study was carried out as a single-blind randomized controlled study to investigate the effect of a foot bath on sleep quality in the elderly.
Detailed description
Sleep consists of psychological, physiological, and social dimensions and has an extremely significant function in meeting basic human needs. Sleep affects everyone's daily life and quality of life. One of the concepts that have been emphasized and gained importance recently is "sleep quality". Sleep quality is defined as "an individual's feeling ready and energetic for a new day after waking up". It is thought that sleep quality also has quantitative aspects such as falling asleep, sleep duration, number of awakenings at night, and subjective aspects such as restfulness or depth of sleep.
The population of elderly individuals is increasing day by day worldwide. In the changing age pyramid, the rate of elderly population was 9.7 % (8245124 people) (over 65 years of age) in 2021 and is estimated to be 11.0 % in 2025, 12.9 % in 2030, 16.3 % in 2040, 22.6 % in 2060, and 25.6% in 2080. With increasing age, changes occur in normal sleep patterns, complaints of insomnia increase, and satisfaction with sleep quality decreases. According to a literature review, sleep problems rank third among the reasons for visiting a doctor in the elderly, after digestive system problems and headache symptoms. The inability to fall asleep, waking up early in the morning, waking up frequently at night, and sleeping during the day are among the most common sleep-related problems in the elderly.
Sleep problems in the elderly can cause serious problems but are also preventable. In this sense, all health personnel, especially nurses, should apply comprehensive nursing care to minimize sleep problems and improve sleep quality in the elderly. Pharmacological treatment is generally employed in the elimination of sleep problems. However, pharmacological treatment is inadequate in eliminating sleep problems, so the elderly continuously use medication, which can cause side effects. On the other hand, the tendency toward non-pharmacological treatment has recently increased, and developments have been achieved in non-pharmacological treatment methods. It has been reported that methods such as music therapy, eye mask, complementary therapies, massage, aromatherapy, and a foot bath are used to improve the sleep quality of elderly people with sleep problems. Foot baths are reported to facilitate falling asleep by affecting body temperature. Sleep quality may improve in patients whose falling asleep process becomes easier. However, to the best of this knowledge, no study has been found in Turkey in which foot baths are used in the elderly and other populations. After all these considerations, the effect of a foot bath on sleep quality in the elderly was analyzed in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The sample size was calculated as 36 (18 for each group) elderly in total for the two groups (foot bath group, control group) with an effect size of 1,000 and the power of the targeted test was 0.90 (90%) in the G*Power 3.1.9.6 program with the error of α=0.05 and a reference to a previous study on the subject (14). Considering the cases such as withdrawal from the study or death during the research, each group was increased and a total of 50 elderly individuals, 25 elderly people for each group, were recruited for the study
| Arm | Type | Receives |
|---|---|---|
| Foot Bath Group | Experimental | Other: Foot Bath GroupThis group of elderly people were taught the foot bath practically by a researcher at the pre-study meeting and were given the "Foot Bath Information Brochure" and a "personalized water thermometer". The other researcher administered the "Elderly Information Form" and "PSQI" to all elderly people before the study using individual interviews lasting approximately 15 minutes and pen and paper method. The elderly were asked to soak their feet in the water in a marked plastic container with a depth of 10 centimeters and a temperature of 41-42°C for 20 minutes up to their ankles 50 minutes before normal sleeping hours every night for 8 weeks. In addition, the PSQI, which provides information about sleep quality, type, and severity of sleep disturbance, was applied to the elderly before the study (pretest), 4th week (interim measurement/1st measurement), and at the end of the study (8th week) for a total of 3 times during 8 weeks. |
| Control Group | No intervention | –No application was made to the elderly in this group. Only the PSQI, which gives information about sleep quality, type, and severity of sleep disturbance, was administered to the elderly before the study (pretest), at the 4th week (interim measurement/1st measurement), and at the end of the study (8th week) for a total of 3 times for 8 weeks. |
Who may qualify
- Ages
- 65 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Being 65 years old or older,
- Being literate,
- Performing activities of daily living,
- Not having problems with the sense organs (such as eyes, ears, skin),
- Not being paraplegic/hemiplegic,
Key exclusion criteria (6 listed)
- Refusing to participate in the research,
- Having psychological disorders,
- Using complementary therapy to sleep,
- Having enuresis,
- Being bedridden or using a wheelchair, and
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 Bath GroupThe elderly were asked to soak their feet in the water in a marked plastic container with a depth of 10 centimeters and a temperature of 41-42°C for 20 minutes up to their ankles 50 minutes before normal sleeping hours every night for 8 weeks. | Other | Foot Bath Group |
Primary outcome
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 week
PSQI is an index that questions sleep quality, type, and severity of sleep disturbance in the last month in adults. 19 questions are answered by the person himself/herself, and 5 questions are answered by the person's bedmate or people sleeping in the same room. The PSQI, which provides information about sleep quality, type, and severity of sleep disturbance, was applied to the elderly before the study (pretest), 4th week (interim measurement/1st measurement), and at the end of the study (8th week) for a total of 3 times during 8 weeks.
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 15 Nov 2023.
- 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.
Hatice Demirağ, Dr.Öğr.Üyesi principal investigator
Gümüşhane Universıty
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 Group in people with Elderly and Sleep Quality, run by Hatice Demirağ, Ph.D 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 7 inclusion and 6 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 15 Nov 2023. 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?
The Pittsburgh Sleep Quality Index (PSQI) (time frame: 8 week). 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 15 Nov 2023.