The Effect of Hot Foot Bath on Sleep Quality and Fatigue

NCT06864923 | Not Yet Recruiting

• 1 other identifier: 2023-28/12
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be conducted to investigate the effects of hot foot baths on patients' sleep quality and fatigue severity levels.The study will be conducted in the Gastroenterology clinic of a university hospital in Türkiye. The research sample will consist of 60 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application. No application will be applied to the control group, and sleep and fatigue levels will be measured in a similar manner to the measurement tools applied to the intervention group and the application days.

Conditions

Hepatitis B

Keywords

fatigue; sleep quality; foot bath

Outcome Measures

Primary Outcomes (2)

• fatigue severity in score (0-10)

  Brief Fatigue Inventory: Scoring ranges from "0" to "10", with "0" indicating no effect and "10" indicating the highest level of effect. The general fatigue score is calculated by dividing the total score of items 1, 2 and 3 by 3, and the effect score of fatigue on daily living activities is calculated by dividing the total score of items 4a, 4b, 4c, 4d, 4e and 4f by 6. A score of "0" obtained from the KYE indicates no fatigue, "1-3" indicates low fatigue, "4-6" indicates moderate fatigue, "7-9" indicates high fatigue and "10" indicates the highest level of effe

  4 months

• Sleep Quality in score

  Sleep Quality Scale: It consists of a total of 18 items. It includes items related to the sleep process and sleep satisfaction.

  4 months

Secondary Outcomes (1)

• weight

  4 months

Study Arms (2)

Hot foot bath application group

EXPERIMENTAL

Other: Hot foot bath application group

Control group

NO INTERVENTION

Interventions

Hot foot bath application group OTHER

The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application.

Hot foot bath application group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being over the age of 18,
• having no disorder which could affect pain perception,
• having no communication problem, and voluntarily agreeing to participate in the research,
• Having been admitted to the clinic at least 24 hours ago,
• Not having a diagnosed sleep disorder,
• Not having a psychiatric disorder requiring treatment,
• Not having a problem with vital signs before the application,
• Not using narcotic drugs in the last 4 hours,
• Not eating two hours before going to bed at night

You may not qualify if:

• being under the age of 18
• not being conscious, refusing to participate in the research or opting to leave the study at any point,
• Having a problem with vital signs before the application,
• Having a diagnosed sleep disorder.

Sponsors & Collaborators

• Uludag University: lead

MeSH Terms

Conditions

Hepatitis B; Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Dilek Yılmaz, PhD

CONTACT

+902242942454; dilekk@uludag.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Bursa Uludag University, Department of Nursing

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: March 5, 2025
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03