Back to resultsThe Effect of Foot Reflexology in Intensive Care Nurses
Primary Purpose
Fatigue, Pain, Stress
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
massage
Sponsored by
About this trial
This is an interventional supportive care trial for Fatigue
Eligibility Criteria
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.
Sites / Locations
- Ayşe Gül Parlak
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group (reflexology group)
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
pain severity
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
fatique
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".
stress
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.
Secondary Outcome Measures
pain severity
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
fatique
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".
stress
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05679726
Brief Title
The Effect of Foot Reflexology in Intensive Care Nurses
Official Title
The Effect of Foot Reflexology on Stress, Fatigue and Low Back Pain in Intensive Care Nurses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafkas University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Pain, Stress, Nurse
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group (reflexology group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
massage
Intervention Description
reflexology foot massage
Primary Outcome Measure Information:
Title
pain severity
Description
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
Time Frame
pre test
Title
fatique
Description
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".
Time Frame
pre test
Title
stress
Description
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.
Time Frame
pre test
Secondary Outcome Measure Information:
Title
pain severity
Description
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
Time Frame
post test(at the end of the 4th week)
Title
fatique
Description
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".
Time Frame
post test (at the end of the 4th week)
Title
stress
Description
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.
Time Frame
post test(at the end of the 4th week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe Gül Parlak, PhD
Organizational Affiliation
Kafkas University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayşe Gül Parlak
City
Kars
ZIP/Postal Code
36000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Foot Reflexology in Intensive Care Nurses
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