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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05679726
Other study ID # kafkasU-80576354
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date April 30, 2023

Study information

Verified date October 2023
Source Kafkas University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
massage
reflexology foot massage

Locations

Country Name City State
Turkey Ayse Gül Parlak Kars

Sponsors (1)

Lead Sponsor Collaborator
Kafkas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
pre test
Primary 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". pre test
Primary 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. pre test
Secondary 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
post test(at the end of the 4th week)
Secondary 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". post test (at the end of the 4th week)
Secondary 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. post test(at the end of the 4th week)
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