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Completed

NCT Number: NCT06217497

The Effect of Foot Massage in Patients Undergoing Hemodialysis

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.

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Key information

Conditions

Nurse-Patient Relations Dyssomnias Fatigue Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harran University

Sanliurfa, 63700, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Piper fatigue scale

    Time frame: Last 2 weeks and last 4 weeks

    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.

Secondary outcomes

  1. Pittsburgh sleep quality index

    Time frame: Last 2 weeks and last 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2024
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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