FatigueNCT05679726
The Effect of Foot Reflexology in Intensive Care Nurses
A study testing massage in people with Fatigue and Pain, run by Kafkas University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
Show all 9Show fewer
- Vascular disease and foot fracture, wound, scar, skin damage etc. no situation
- Volunteered to participate in the research
- Not using antidepressants, sleeping pills, etc.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Foot Reflexology on Stress, Fatigue and Low Back Pain in Intensive Care Nurses
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.
Read the 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.
- Being tested
- massage
- Medical subject headings
- Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageBehavioural
reflexology foot massage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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".
Measured: 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.
Measured: pre test
Secondary 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
Measured: post test(at the end of the 4th week)
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".
Measured: post test (at the end of the 4th week)
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.
Measured: post test(at the end of the 4th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Nov 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Gul Parlak, Kafkas University
- Investigators
- Ayşe Gül Parlak, PhD, Principal investigator, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679726
- Sponsor's protocol ID
- kafkasU-80576354
- Status last verified
- Oct 2023
- First submitted
- 2 Jan 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Reflexology on Stress, Fatigue and Low Back Pain in Intensive Care Nurses
- ClinicalTrials.gov ID
- NCT05679726
- Acronym / sponsor ID
- kafkasU-80576354
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (reflexology group) | Experimental | Behavioral: massageThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- -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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massagereflexology foot massage | Behavioural | Intervention group (reflexology group) |
Primary outcome
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
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".
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.
3 secondary outcomes
pain severity
Time frame: post test(at the end of the 4th week)
fatique
Time frame: post test (at the end of the 4th week)
stress
Time frame: post test(at the end of the 4th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Gül Parlak, PhD principal investigator
Kafkas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage in people with Fatigue and Pain, run by Kafkas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain severity (time frame: pre test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.