NCT06758687

Brief 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. 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..

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

December 19, 2024

Last Update Submit

January 3, 2025

Conditions

Keywords

Operating room nurselower back painsleep qualityfatiguekinesio taping

Outcome Measures

Primary Outcomes (13)

  • 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 kinesio tape application

  • 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".

    12 hours after kinesio tape application

  • 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".

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

  • 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".

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

  • 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 kinesio tape application

  • 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

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

  • 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

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

  • 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 kinesio tape application

  • 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.

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

  • 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.

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

  • 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 kinesio tape application

  • 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.

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

  • 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.

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

Study Arms (5)

Introductory Information Form

NO INTERVENTION

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.

Visual Analog Skala

EXPERIMENTAL

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".

Other: Kinesiotape Application

Quebec Low Back Pain Disability Scale

EXPERIMENTAL

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

Other: Kinesiotape Application

Visual Similarity Scale for Fatigue

EXPERIMENTAL

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.

Other: Kinesiotape Application

Richard-Campbell Sleep Scale

EXPERIMENTAL

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.

Other: Kinesiotape Application

Interventions

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

Quebec Low Back Pain Disability ScaleRichard-Campbell Sleep ScaleVisual Analog SkalaVisual Similarity Scale for Fatigue

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainSleep Initiation and Maintenance DisordersFatigue

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Kezban Sözen Sözen, PhD.

CONTACT

Kezban Sözen Sözen, PhD.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

December 19, 2024

First Posted

January 6, 2025

Study Start

January 1, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

January 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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.