- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05679726
The Effect of Foot Reflexology in Intensive Care Nurses
The Effect of Foot Reflexology on Stress, Fatigue and Low Back Pain in Intensive Care Nurses
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kars, Turkey, 36000
- Ayşe Gül Parlak
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Ayşe Gül Parlak, PhD, Kafkas University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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