The Effect of Foot Reflexology in Intensive Care Nurses

October 13, 2023 updated by: Ayse Gul Parlak, Kafkas University

The Effect of Foot Reflexology on Stress, Fatigue and Low Back Pain in Intensive Care Nurses

This study was planned as a randomized controlled experimental research design to examine the effect of foot reflexology applied to nurses working in the intensive care unit on stress, fatigue and low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The universe of the research consisted of a total of 90 nurses working in a university and a public hospital in a city. Among the nurses, those who meet the criteria for inclusion in the study will form the sample. Assignment to the intervention and control group will be determined in the computer environment using a simple randomization method (www.randomizer.org/). The number of samples was determined using power analysis. It was decided to recruit a total of 42 nurses, 21 for each group.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kars, Turkey, 36000
        • Ayşe Gül Parlak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • -Intensive care unit nurse
  • Those aged 18 to 65 years
  • Working in intensive care for at least 6 months
  • Back pain for at least 3 months
  • Not pregnant, non-breastfeeding
  • Having a regular menstrual cycle
  • Vascular disease and foot fracture, wound, scar, skin damage etc. no situation
  • Volunteered to participate in the research
  • Not using antidepressants, sleeping pills, etc.

Exclusion Criteria:

  • Working in intensive care for less than 6 months
  • No chronic low back pain
  • Pregnant, lactating
  • Do not have a regular menstrual cycle
  • Vascular disease and foot fracture, wound, scar, skin damage etc. situation found
  • Using antidepressants, sleeping pills, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group (reflexology group)
The group in which reflexology massage (foot massage) was applied once a week for 20 minutes (10 minutes on each foot) for a total of 4 weeks, and the pain scale and fatigue and stress level were measured once a week at the beginning of the study and at the end of the study 4 weeks later.
reflexology foot massage
No Intervention: Control group
Pain scale once a week for 4 weeks without any application, and fatigue and stress level at the beginning of the study and at the end of the study after 4 weeks were measured in the group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain severity
Time Frame: pre test

measurement of nurses' low back pain severity score

A Visual Analogue Scale (VAS) is one of the pain rating scales. VAS pain score is evaluated as "painless" (score=0) and "worst pain" (score=10).

score <3 mild pain, 3-6 mild-to-moderate pain, and >6 moderate-to-severe pain

pre test
fatique
Time Frame: pre test
The fatigue severity scale There are 9 questions in the scale and each question consists of 7 points. An increase in the scale score indicates an increase in the level of fatigue. The scale determines the fatigue status of individuals in the last 1 month. Questions are scored as I totally disagree (1)- I totally agree. If the average score is 5 and above, it is considered as "fatigue".
pre test
stress
Time Frame: pre test
Perceived Stress Scale ; There are 14 items in the scale, which was developed as a five-point Likert-type rating scale. The scale consists of "never (0), almost never" (1), "sometimes" (2), "often" (3) "very often" (4). The lowest and highest scores a participant can obtain from this scale are 0 and 56, respectively.
pre test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain severity
Time Frame: post test(at the end of the 4th week)

measurement of nurses' low back pain severity score

A Visual Analogue Scale (VAS) is one of the pain rating scales. VAS pain score is evaluated as "painless" (score=0) and "worst pain" (score=10).

score <3 mild pain, 3-6 mild-to-moderate pain, and >6 moderate-to-severe pain

post test(at the end of the 4th week)
fatique
Time Frame: post test (at the end of the 4th week)
The fatigue severity scale There are 9 questions in the scale and each question consists of 7 points. An increase in the scale score indicates an increase in the level of fatigue. The scale determines the fatigue status of individuals in the last 1 month. Questions are scored as I totally disagree (1)- I totally agree. If the average score is 5 and above, it is considered as "fatigue".
post test (at the end of the 4th week)
stress
Time Frame: post test(at the end of the 4th week)
Perceived Stress Scale ; There are 14 items in the scale, which was developed as a five-point Likert-type rating scale. The scale consists of "never (0), almost never" (1), "sometimes" (2), "often" (3) "very often" (4). The lowest and highest scores a participant can obtain from this scale are 0 and 56, respectively.
post test(at the end of the 4th week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ayşe Gül Parlak, PhD, Kafkas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kafkasU-80576354

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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