The Effect of Foot Reflexology in Intensive Care Nurses

Sponsor
Kafkas University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05679726
Collaborator
(none)
42
1
2
3.9
10.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: massage
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Foot Reflexology on Stress, Fatigue and Low Back Pain in Intensive Care Nurses
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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.

Behavioral: massage
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.

Outcome Measures

Primary Outcome Measures

  1. pain severity [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

  2. fatique [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".

  3. stress [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.

Secondary Outcome Measures

  1. pain severity [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

  2. fatique [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".

  3. stress [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ayşe Gül Parlak Kars Turkey 36000

Sponsors and Collaborators

  • Kafkas University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ayse Gul Parlak, assistant proffessor, Kafkas University
ClinicalTrials.gov Identifier:
NCT05679726
Other Study ID Numbers:
  • kafkasU-80576354
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023