NCT07048015

Brief Summary

Aim: A randomized controlled experimental study was conducted to determine the effect of hot water foot bath on daily living activities, sleep and fatigue levels in frail geriatric individuals. Method: The study was conducted at Eskişehir Çifteler State Hospital internal medicine clinic between 15.10.2023 - 15.07.2024. 30 patients who met the sample selection criteria were randomized into two groups (study and control). Foot bath was applied to the study group every evening for 10 days. The study group was evaluated twice times on the 1st, 11th days, and the control group was evaluated twice on the 1st and 11th days in terms of frailty level, daily living activities, insomnia and fatigue severity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
Last Updated

July 17, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

May 21, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

frail elderlyfoot bathdaily living activitiesinsomniafatiguepain

Outcome Measures

Primary Outcomes (1)

  • Effect of hot water foot bath on daily living activities, sleep and fatigue levels in frail geriatric individuals

    Frail geriatric individuals were given hot water foot baths. The effects of this application on the individuals' daily living activities, sleep and fatigue levels were investigated. In the study, the individuals were administered the Edmoton Frailty Scale, the Katz Daily Living Activities Scale, the Insomnia Severity Index and the Fatigue Severity Scale via face-to-face interviews.

    from registration until the end of the 40th day

Study Arms (2)

Foot bath

EXPERIMENTAL

Foot bath: The foot bath was applied to the patients in the intervention group once a day for 20 minutes for 10 days.

Other: Hot Water Foot Bath

control group

NO INTERVENTION

No intervention was made to the patients in the control group other than the medical treatment and care protocol.

Interventions

Hot Water Foot Bath:When the water temperature reached 40 ° C, the elderly person's feet were placed in the foot bath tub. The elderly person's feet were kept in the water for 20 minutes.

Foot bath

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients aged 65 and over
  • At least literate
  • Able to communicate
  • With an Edmonton Frailty Scale score of 7 and above were included in the study.

You may not qualify if:

  • Patients diagnosed with a disease that may affect their mental status, such as dementia
  • Those who have used other treatment methods such as massage or cupping therapy in the last month
  • Those whose systolic blood pressure is lower than 100 mmHg
  • Those diagnosed with malignancy and acute inflammatory rheumatic disease
  • Those who have undergone any surgical operation in at least 6 months
  • Those who have an orthopedic implant (in the foot or leg area)
  • Those who have paralysis and paralysis
  • Those who have peripheral vascular disease
  • Those who have ulcerative lesions in the legs
  • Those who have a psychiatric disease diagnosis
  • Those who are immobile
  • Those who have fungal infections in their feet
  • Those who are included in another study
  • Those who have had a change in their treatment and nursing care process
  • Those who have a diagnosis of neuropathy
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

Location

Related Publications (1)

  • Malarvizhi, K. R. (2019). A study to assess the effectiveness of hot water foot bath therapy on quality of sleep among elderly staying in selected old age home at Villupuram District, Tamilnadu. International Journal of Health Sciences and Research, 4(4), 83-88.

    BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersFatiguePain

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The first assessments (day 1) were made by the researcher using the Individual Identification Form, Katz Activities of Daily Living Scale, Insomnia Severity Index and Fatigue Severity Scale from patient files and face-to-face interviews with the patients. Foot bath was applied to the patients in the intervention group for 20 minutes once a day for 10 days. No intervention was made to the patients in the control group other than the medical treatment and care protocol. The second assessment was made on the 11th day by applying the , Katz Activities of Daily Living Scale, Insomnia Severity Index and Fatigue Severity Scale to the patients in the study and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

May 21, 2025

First Posted

July 2, 2025

Study Start

October 15, 2023

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

July 17, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations