Clinical trial NCT05572554: The Effect of a Foot Bath on Sleep Quality in The Elderly
Official title: The Effect of a Foot Bath on Sleep Quality in The Elderly: A Single-Blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Sleep Quality
Complementary Therapy
Chronic Disease
Keywords: Elderly
Sleep quality
Foot bath
Complementary therapy
Chronic disease
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 81
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gümüşhane
country: Turkey
facility: Gümüşhane University
state: Kelki̇t
Study officials:
affiliation: Gümüşhane Universıty
name: Hatice Demirağ, Dr.Öğr.Üyesi
role: PRINCIPAL_INVESTIGATOR
References: