The Effect of Foot Massage in Patients Undergoing Hemodialysis

The Effect of Foot Massage Applied to Patients Undergoing Hemodialysis on Sleep Quality and Fatigue Level:Randomized Controlled Study

Hemodialysis patients were divided into experimental and control groups. Foot massage was applied to the patients in the experimental group. Foot massage was not applied to the patients in the control group and routine nursing care was provided. Pre-test, mid-test and post-test sleep quality and fatigue level scores of the patients were determined.

Study Overview

• Status: Completed
• Conditions: Nurse-Patient Relations
• Intervention / Treatment: Other: Foot massage

Detailed Description

An experimental study design was used to conduct this research on 73 hemodialysis patients treated in a hemodialysis unit. The aim of this study is to investigate how foot massage applied to hemodialysis patients affects sleep quality and fatigue level.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Şanlıurfa, Turkey, 63700
    • Harran University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion Criteria were determined as follows:

  • Having a PSQI score of 5 points and above
  • Receiving HD treatment for at least 6 months
  • Having no neuropathy d) Using no sleeping pills
  • Having no communication problem
  • Having full orientation and no psychiatric problems
  • Having no conditions in the lower extremities and feet that would preclude massaging (no open wounds on the skin, orthopaedic and joint problems, oedema, abscess, infection, thrombophlebitis, deep vein thrombosis, thrombocytopenia, etc.)
  • Having no history of allergy to the oil used for massage.

Exclusion Criteria:

Exclusion criteria were determined as follows:

• Receiving less than 6 months of HD treatment
• Having communication problem
• Suffering from neuropathy
• Having incomplete orientation and any psychiatric problem
• Having a PSQI score below 5
• Having conditions in the lower extremities and feet that would preclude massaging (open wounds on the skin, orthopaedic and joint problems, oedema, abscess, infection, thrombophlebitis, deep vein thrombosis, thrombocytopenia, etc.) and having a history of allergy to the oil used for massage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; After the patients in the experimental group were informed verbally and in writing and consented to participate in the study, the Patient Information Form, the Piper Fatigue Scale (PFS), and the Pittsburgh Sleep Quality Index (PSQI) were applied in the first interview and the initial readings were obtained. The researcher received training on a classical massage from an expert massage therapist before the foot massaging application. Patients in the experimental group were subjected to a foot massage with baby oil for 10 minutes during HD treatment three times a week for four weeks, 12 times in total. At the end of the second and fourth weeks after the foot massage, the second and third readings were recorded by repeating the PFS and PSQI.	Other: Foot massage; Patients in the experimental group were subjected to a foot massage with baby oil for 10 minutes during HD treatment three times a week for four weeks, 12 times in total. At the end of the second and fourth weeks after the foot massage, the second and third readings were recorded by repeating the PFS and PSQI
No Intervention: Control Group; Patients in the control group were not subjected to any intervention other than routine HD treatment and nursing care. The first readings were obtained by applying the Patient Information Form, PFS and PSQI at the first interview, and the second and third measurement values were obtained by repeating the PFS and PSQI at the end of the second and fourth weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Piper fatigue scale	Piper Fatigue Scale (PFS) was developed by Piper et al. The scale consists of a total of 22 items. Each item is rated over 0-10 points through Visual Analogue Scale (VAS) under four subscales related to the patient's subjective perception of fatigue. The behavioural subscale consists of 6 items (2-7), the affective subscale consists of 5 items (8-12), the sensory subscale consists of 5 items (13-17), and the cognitive subscale consists of 6 items [18-23]. Total fatigue score and subscale scores are calculated over 22 items. Items 1, 24, 25, 26 and 27 in the scale are not used in calculating the fatigue score. Total fatigue score is obtained by summing the items and dividing the resultant value by the total number of items, and subscale scores are obtained by summing the scores of all items in that subscale and dividing the resultant value by the number4 of items.	Last 2 weeks and last 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh sleep quality index	The Pittsburgh Sleep Quality Index (PSQI) was developed by Buysse et al., . Turkish validity and reliability study of the scale was conducted by Ağargün et al.,. The index, which evaluates sleep quality, sleep duration, sleep latency, sleep disturbance and severity in the last 4 weeks, consists of a total of 24 items. 19 items in the index are self-assessment questions, the last 5 questions are answered by the individual's roommate or spouse, and the last 5 questions are not included in the scoring. There are seven components of the PSQI (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, daytime dysfunction). The sum of these seven components gives the total PSQI score. Total score ranges from 0-21, and each item gets a score between 0-3 points. A PSQI total score of 5 points and above indicates that the sleep quality is "poor" and a higher score indicates more sleep complaints.	Last 2 weeks and last 4 weeks

Collaborators and Investigators

• Sponsor: Harran University
• Investigators: Principal Investigator: Seyhan Çıtlık SARITAŞ, PhD, Turgut ÖZAL University

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): February 12, 2022
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Fatigue; Nursing; Sleep Quality; Hemodialysis; Foot Massage
• Other Study ID Numbers: Hemodialysis and Foot Massage

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study was conducted in a randomized controlled manner with experimental and control groups.
• IPD Sharing Time Frame: No time limit
• IPD Sharing Access Criteria: All data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No