NCT05679726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

January 2, 2023

Last Update Submit

October 13, 2023

Conditions

FatiguePainStressNurse

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • pain severity

    post test(at the end of the 4th week)

  • fatique

    post test (at the end of the 4th week)

  • stress

    post test(at the end of the 4th week)

Study Arms (2)

Intervention group (reflexology group)

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

massageBEHAVIORAL

reflexology foot massage

Intervention group (reflexology group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Gül Parlak

Kars, 36000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FatiguePain

Interventions

Massage

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Ayşe Gül Parlak, PhD

    Kafkas University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant proffessor

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 11, 2023

Study Start

November 1, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)