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Lower Back PainNCT06758687

The Effect of Kinesio Taping Applied to Operating Room Nurses on Low Back Pain, Fatigue, and Sleep Quality

A study testing Kinesiotape Application in people with Lower Back Pain and Kinesio Taping, run by Nigde Omer Halisdemir University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to determine the effects of kinesiology taping applied to operating room nurses on lower back pain, fatigue, and sleep quality. The research will be conducted using a randomized controlled experimental design with pre-test and post-test control groups. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Lower Back Pain, Kinesio Taping
What is being tested?
Kinesiotape Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Jan 2025to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Volunteering to participate in the study
  • Working in the operating room for at least one year

Who cannot join

  • Presence of conditions that will prevent the application of kinesio tape (excessive hair in the area where it is applied, skin rash, urticaria, etc.)
  • Necessity for continuous use of analgesics
  • Desire to leave the study while the study is ongoing
  • Allergic reaction or skin irritation to kinesio tape during the study
  • Use of analgesics during the period when kinesio tape is applied

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kezban Sözen Sözen, PhD. contact

+905438056209

kezbankoras@ohu.edu.tr

Kezban Sözen Sözen, PhD. contact

kezbankoras@ohu.edu.tr

About this study

Official title: The Effect of Kinesio Taping Applied to Operating Room Nurses on Low Back Pain, Fatigue, and Sleep Quality: A Randomized Controlled Trial

This study aims to determine the effects of kinesiology taping applied to operating room nurses on lower back pain, fatigue, and sleep quality. The research will be conducted using a randomized controlled experimental design with pre-test and post-test control groups. The universe of the study will consist of 100 operating room nurses working in a university hospital. The sample size has been calculated as a total of 84 nurses (Intervention group: 42; Control group: 42) based on power analysis calculations. The study will commence after obtaining the necessary permissions. Data collection will involve the use of the Descriptive Information Form, Visual Analog Scale, Quebec Back Pain Disability Scale, Visual Analogue Scale for Fatigue, and the Richards-Campbell Sleep Questionnaire. Participants who consent to the study will be administered the Descriptive Information Form, Visual Analog Scale, Quebec Back Pain Disability Scale, Visual Analogue Scale for Fatigue, and Richards-Campbell Sleep Questionnaire before the application of kinesiology tape. Subsequently, a physiotherapist from the research team will apply kinesiology tape to the paravertebral muscles using the muscle technique. As the literature suggests that the most suitable number of days for kinesiology tape application is four, participants will be instructed not to remove the tapes for four days. Additionally, participants will be informed that they can continue their daily activities and shower with the kinesiology tape on. The Visual Analog Scale will be applied to the participants at the end of the workday on the day of the kinesiology tape application and at the end of the workday for four days. At the end of the fourth day, all data collection tools will be applied. Seven days after the application, the scales will be filled out again by the nurses to determine if the effects of the kinesiology tape persist. Participants in the control group who agree to participate in the study will have data collected at the same time intervals as the intervention group participants using the same data collection tools. The Visual Analogue Scale will be administered to participants at the end of the day the data collection tools are filled out and at the end of the workday for four consecutive days. At the end of the fourth day, all data collection tools will be applied again. Seven days after the application, all scales will be refilled by the nurses..

Being tested
Kinesiotape Application
Keywords
Operating room nurse, lower back pain, sleep quality, fatigue, kinesio taping
Medical subject headings
Low Back Pain, Sleep Initiation and Maintenance Disorders, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinesiotape ApplicationOther

    Before the appropriate taping is applied to the waist area, a small piece of kinesio tape will be attached to the participant's thigh area and an allergy test will be performed. If the participant does not have any complaints within 5-10 minutes, the participant will be taped. The tape to be used in this study will be waterproof, porous, breathable, 5 cm wide and 0.5 mm thick.

    After the initial evaluation is completed, kinesio taping will be applied to the paravertebral muscles. First, the participant will be asked to perform trunk flexion while standing with their forearms supported by a table. While the participant is in this position, two "I" shaped tapes will be attached to the right and left sides of the spine (in the cranial direction) along the paravertebral muscle line without applying tension. Then, the field correction technique will be applied. While the participant is standing with their forearms supported on the table, four "I" tapes overlapping in

Study groups in NCT06758687
Study groupRoleWhat they receive
Introductory Information FormNo interventionIt is a form prepared by the researcher in line with the literature, including questions such as age, professional experience, number of weekly working days, average daily surgery duration, exercise habits, smoking and alcohol consumption habits, musculoskeletal system problems, operating room conditions and equipment satisfaction.
Visual Analog SkalaExperimentalVAS is used by having the patient mark the intensity of their pain on a 10 cm ruler ranging from "No pain" to "Unbearable pain".
Receives: Other: Kinesiotape Application
Quebec Low Back Pain Disability ScaleExperimentalIncludes a 20-item questionnaire to measure disability experienced during daily life activities. The five-point Likert-type scoring system used in this scale shows that the level of disability is high as the score increases
Receives: Other: Kinesiotape Application
Visual Similarity Scale for FatigueExperimentalThe 18-item scale developed by Yurtsever and Beduk in 2003, includes two subscales: fatigue and energy. While the items related to fatigue cover the items from 1 to 5 and 11 to 18, the items related to energy are from 6 to 10. Each item is evaluated on a 10 cm long line, from the most positive to the most negative expression or vice versa. High scores on the fatigue subscale and low scores on the energy subscale indicate increased fatigue.
Receives: Other: Kinesiotape Application
Richard-Campbell Sleep ScaleExperimentalThis scale evaluates six different factors such as the depth of night sleep, time it takes to fall asleep, frequency of awakenings, time it takes to stay awake, general quality of sleep, and environmental noise level. Each factor is scored between 0 and 100 using a visual analog scale. Scores between "0 and 25" indicate poor sleep quality, while scores between "76 and 100" indicate good sleep quality.
Receives: Other: Kinesiotape Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Skala

    VAS is used by having the patient mark the intensity of their pain on a 10 cm ruler ranging from "No pain" to "Unbearable pain".

    Measured: Before kinesio tape application

  2. Visual Analog Skala

    VAS is used by having the patient mark the intensity of their pain on a 10 cm ruler ranging from "No pain" to "Unbearable pain".

    Measured: 12 hours after kinesio tape application

  3. Visual Analog Skala

    VAS is used by having the patient mark the intensity of their pain on a 10 cm ruler ranging from "No pain" to "Unbearable pain".

    Measured: Kinesiotape application will be applied on the 2nd, 3rd and 4th days after work at 20:00 pm.

  4. Visual Analog Skala

    VAS is used by having the patient mark the intensity of their pain on a 10 cm ruler ranging from "No pain" to "Unbearable pain".

    Measured: Will be re-evaluated 7 days after the 4-day application (11th day)

  5. Quebec Low Back Pain Disability Scale

    Includes a 20-item questionnaire to measure disability experienced during daily life activities. The five-point Likert-type scoring system used in this scale shows that the level of disability is high as the score increases

    Measured: Before kinesio tape application

  6. Quebec Low Back Pain Disability Scale

    Includes a 20-item questionnaire to measure disability experienced during daily life activities. The five-point Likert-type scoring system used in this scale shows that the level of disability is high as the score increases

    Measured: 4th day of kinesio tape application at 08:00 pm

  7. Quebec Low Back Pain Disability Scale

    Includes a 20-item questionnaire to measure disability experienced during daily life activities. The five-point Likert-type scoring system used in this scale shows that the level of disability is high as the score increases

    Measured: Will be re-evaluated 7 days after the 4-day application (11th day)

  8. Visual Similarity Scale for Fatigue

    The 18-item scale developed by Yurtsever and Beduk in 2003, includes two subscales: fatigue and energy. While the items related to fatigue cover the items from 1 to 5 and 11 to 18, the items related to energy are from 6 to 10. Each item is evaluated on a 10 cm long line, from the most positive to the most negative expression or vice versa. High scores on the fatigue subscale and low scores on the energy subscale indicate increased fatigue.

    Measured: Before kinesio tape application

  9. Visual Similarity Scale for Fatigue

    The 18-item scale developed by Yurtsever and Beduk in 2003, includes two subscales: fatigue and energy. While the items related to fatigue cover the items from 1 to 5 and 11 to 18, the items related to energy are from 6 to 10. Each item is evaluated on a 10 cm long line, from the most positive to the most negative expression or vice versa. High scores on the fatigue subscale and low scores on the energy subscale indicate increased fatigue.

    Measured: 4th day of kinesio tape application at 08:00 pm

  10. Visual Similarity Scale for Fatigue

    The 18-item scale developed by Yurtsever and Beduk in 2003, includes two subscales: fatigue and energy. While the items related to fatigue cover the items from 1 to 5 and 11 to 18, the items related to energy are from 6 to 10. Each item is evaluated on a 10 cm long line, from the most positive to the most negative expression or vice versa. High scores on the fatigue subscale and low scores on the energy subscale indicate increased fatigue.

    Measured: Will be re-evaluated 7 days after the 4-day application (11th day)

  11. Richard-Campbell Sleep Scale

    This scale evaluates six different factors such as the depth of night sleep, time it takes to fall asleep, frequency of awakenings, time it takes to stay awake, general quality of sleep, and environmental noise level. Each factor is scored between 0 and 100 using a visual analog scale. Scores between "0 and 25" indicate poor sleep quality, while scores between "76 and 100" indicate good sleep quality.

    Measured: Before kinesio tape application

  12. Richard-Campbell Sleep Scale

    This scale evaluates six different factors such as the depth of night sleep, time it takes to fall asleep, frequency of awakenings, time it takes to stay awake, general quality of sleep, and environmental noise level. Each factor is scored between 0 and 100 using a visual analog scale. Scores between "0 and 25" indicate poor sleep quality, while scores between "76 and 100" indicate good sleep quality.

    Measured: 4th day of kinesio tape application at 08:00 pm

  13. Richard-Campbell Sleep Scale

    This scale evaluates six different factors such as the depth of night sleep, time it takes to fall asleep, frequency of awakenings, time it takes to stay awake, general quality of sleep, and environmental noise level. Each factor is scored between 0 and 100 using a visual analog scale. Scores between "0 and 25" indicate poor sleep quality, while scores between "76 and 100" indicate good sleep quality.

    Measured: Will be re-evaluated 7 days after the 4-day application (11th day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study startJan 2025 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06758687
Sponsor's protocol ID
Kinezyo2024
Status last verified
Jan 2025
First submitted
19 Dec 2024
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The datasets generated during and/or analysed during the current study are not publicly available due protection of personal data of participants but are available from the corresponding author on reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Kinesiotape Application in people with Lower Back Pain and Kinesio Taping, run by Nigde Omer Halisdemir University.

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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kezban Sözen Sözen, PhD. (+905438056209, kezbankoras@ohu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Skala (time frame: Before kinesio tape application). The study lists 13 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 6 Jan 2025.

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