The Effect of Foot Massage in Patients Undergoing Hemodialysis

NCT06217497 | Completed

• 1 other identifier: Hemodialysis and Foot Massage
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nurse-Patient Relations

Keywords

Foot Massage; Hemodialysis; Nursing; Sleep Quality; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pittsburgh sleep quality index

  Last 2 weeks and last 4 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Foot massage OTHER

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

Experimental Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University

Sanliurfa, 63700, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fatigue

Condition Hierarchy (Ancestors)

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

Study Officials

• Seyhan Çıtlık SARITAŞ, PhD

  Turgut ÖZAL University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: two groups
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Internal Medicine Nursing)

Model Details: This study was conducted in a randomized controlled design.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: January 22, 2024
• Study Start: August 31, 2021
• Primary Completion: February 12, 2022
• Study Completion: June 10, 2022
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: No time limit
• Access Criteria: All data

Locations

TU (1)