The Effects on Sleep qualıty and fatıgue Level of Foot Bath

NCT05668247 | Completed DMC

• 1 other identifier: 2017/370
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Aims and objectives: To determine the effect of foot bath on sleep quality and fatigue level in patients with chronic obstructive pulmonary disease (COPD). Background: İnsomnia and fatigue are one of the most common symptoms in people with COPD and adversely affects their activities of daily living. Design: This study was conducted as a nonrandomized controlled trial. Methods:The study sample comprised 70 patients who met the inclusion criteria.Data were collected with Patient Information Form, Pittsburgh Sleep Quality Index and Piper Fatigue Scale. Intervention group; The 30-day foot bath was administered for 10 minutes before bedtime, while no control was performed in the control group. The Pittsburgh Sleep Quality Index (PUKI) and the Piper Fatigue Scale were administered in both groups at the beginning of the service (first follow-up) and four weeks later (second follow-up) at the outpatient clinic. Conclusions: The foot bath by individuals with COPD was determined to significantly improve the participants'levels sleep quality and fatigue.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; fatigue; foot bath; nursing; sleep quality

Outcome Measures

Primary Outcomes (2)

• Hypotes 1

  The foot bath applied with hot water at 38-40°C for 10 minutes before going to sleep for 30 days is effective in enhancing sleep quality of the individuals staying in the hospital and receiving COPD treatment.

  Ahrough study completion, an average of 1 year

• Hypotes 2

  The foot bath applied with hot water at 38-40°C for 10 minutes before going to sleep for 30 days is effective in decreasing fatigue level of the individuals staying in the hospital and receiving COPD treatment.

  hrough study completion, an average of 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

foot bath is a type of relaxation and care performed by putting feet in water. Feet, as the organs carrying the whole body weight are the body parts where fatigue is felt most. In this study, a specially designed foot bath bucket was used in order to apply foot bath for the patients in the experimental group. The bucket has a five-level water heating system (35-48 °C). It has a magnetic field and operates at 390 Watt. It has a splash shield. There are non-slip rubber legs on its bottom. it has heat protection feature for thermal insulation as it has a two-walled structure

Other: FOOT BATH

Control

NO INTERVENTION

On the first day (the first follow-up), Patient Information Form, PSQI (ANNEX-II) and Piper Fatigue Scale were applied to the patients in the control group whose consent was obtained in the first follow-up, through face-to-face interview. At the end of the 30th day (the second follow-up), PSQI and Piper Fatigue Scale were applied again to the patients who came for the outpatient clinic control. The routine treatment of the control group was not interfered and no intervention was performed.

Interventions

FOOT BATH OTHER

In general, foot bath is a type of relaxation and care performed by putting feet in water. Feet, as the organs carrying the whole body weight are the body parts where fatigue is felt most. In this study, a specially designed foot bath bucket was used in order to apply foot bath for the patients in the experimental group.

Intervention

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients,
• who were diagnosed with COPD,
• were aged between 55-85 years,
• did not have a psychiatric disease requiring treatment,
• had no diagnosed sleep disorder,
• had orientation to person, place, and time, can be communicated verbally,
• had a general state of health enough to perceive the questions in the questionnaire and answer them correctly,
• had a mild (FEV1 ≥ 80%) and moderate (50% ≤ FEV1 \< 80%) COPD stage,
• agreed to participate in the study were included in the study.

You may not qualify if:

• The patients,
• who had Diabetes Mellitus (DM), CVA, CHF, coronary artery disease, coagulation disorders such as varicosity, deep vein thrombosis and disseminated intravascular coagulation,
• were using CPAP (Continuous Positive Airway Pressure) and BIPAP (Bi-level Positive Airway Pressure) devices,
• were diagnosed with sleep disorder,
• had the general condition disorder developed related to diagnosis within the application and control process were excluded from the study.

Sponsors & Collaborators

• Sevil Şahin: lead
• TC Erciyes University: collaborator

Study Sites (1)

Sevil Şahin

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 29, 2022
• Study Start: May 5, 2017
• Primary Completion: April 5, 2018
• Study Completion: April 5, 2018
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)