The Effect of a Foot Bath on Sleep Quality in The Elderly

NCT05572554 | Completed

• 1 other identifier: RCS10052022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly; Sleep Quality; Complementary Therapy; Chronic Disease

Keywords

Elderly; Sleep quality; Foot bath; Complementary therapy; Chronic disease

Outcome Measures

Primary Outcomes (1)

• 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.

  8 week

Study Arms (2)

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.

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.

Interventions

Foot Bath Group OTHER

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.

Foot Bath Group

Eligibility Criteria

• Age: 65 Years - 81 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hatice Demirağ, Ph.D: lead

Study Sites (1)

Gümüşhane University

Gümüşhane, Kelki̇t, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Chronic Disease

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hatice Demirağ, Dr.Öğr.Üyesi

  Gümüşhane Universıty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)