- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06758687
The Effect of Kinesio Taping Applied to Operating Room Nurses on Low Back Pain, Fatigue, and Sleep Quality
The Effect of Kinesio Taping Applied to Operating Room Nurses on Low Back Pain, Fatigue, and Sleep Quality: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kezban Sözen Sözen, PhD.
- Phone Number: +905438056209
- Email: kezbankoras@ohu.edu.tr
Study Contact Backup
- Name: Kezban Sözen Sözen, PhD.
- Email: kezbankoras@ohu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study
- Working in the operating room for at least one year
Exclusion Criteria:
- 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
Exclusion Criteria for the Study
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Introductory Information Form
It 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.
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|
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Experimental: 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".
|
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 |
|
Experimental: 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
|
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 |
|
Experimental: 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.
|
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 |
|
Experimental: 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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Skala
Time Frame: Before kinesio tape application
|
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".
|
Before kinesio tape application
|
|
Visual Analog Skala
Time Frame: 12 hours after kinesio tape application
|
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".
|
12 hours after kinesio tape application
|
|
Visual Analog Skala
Time Frame: Kinesiotape application will be applied on the 2nd, 3rd and 4th days after work at 20:00 pm.
|
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".
|
Kinesiotape application will be applied on the 2nd, 3rd and 4th days after work at 20:00 pm.
|
|
Visual Analog Skala
Time Frame: Will be re-evaluated 7 days after the 4-day application (11th day)
|
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".
|
Will be re-evaluated 7 days after the 4-day application (11th day)
|
|
Quebec Low Back Pain Disability Scale
Time Frame: Before kinesio tape application
|
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
|
Before kinesio tape application
|
|
Quebec Low Back Pain Disability Scale
Time Frame: 4th day of kinesio tape application at 08:00 pm
|
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
|
4th day of kinesio tape application at 08:00 pm
|
|
Quebec Low Back Pain Disability Scale
Time Frame: Will be re-evaluated 7 days after the 4-day application (11th day)
|
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
|
Will be re-evaluated 7 days after the 4-day application (11th day)
|
|
Visual Similarity Scale for Fatigue
Time Frame: Before kinesio tape application
|
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.
|
Before kinesio tape application
|
|
Visual Similarity Scale for Fatigue
Time Frame: 4th day of kinesio tape application at 08:00 pm
|
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.
|
4th day of kinesio tape application at 08:00 pm
|
|
Visual Similarity Scale for Fatigue
Time Frame: Will be re-evaluated 7 days after the 4-day application (11th day)
|
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.
|
Will be re-evaluated 7 days after the 4-day application (11th day)
|
|
Richard-Campbell Sleep Scale
Time Frame: Before kinesio tape application
|
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.
|
Before kinesio tape application
|
|
Richard-Campbell Sleep Scale
Time Frame: 4th day of kinesio tape application at 08:00 pm
|
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.
|
4th day of kinesio tape application at 08:00 pm
|
|
Richard-Campbell Sleep Scale
Time Frame: Will be re-evaluated 7 days after the 4-day application (11th day)
|
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.
|
Will be re-evaluated 7 days after the 4-day application (11th day)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kinezyo2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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