The Effect of Foot Massage in Patients Undergoing Hemodialysis

Nurse-Patient Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06217497
• Other study ID #: Hemodialysis and Foot Massage
• Status: Completed
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: June 10, 2022

Study information

• Verified date: January 2024
• Source: Harran University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 10, 2022
• Est. primary completion date: February 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nurse-Patient Relations

Intervention

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

Locations

Country	Name	City	State
Turkey	Harran University	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Harran University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 Agargün 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