- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07452497
Investigation of the Effect of Kinesiotape Application to the Surgical Area on Pain, Mobilization, Sleep, and Patient Satisfaction
Investigation of the Effects of Kinesiotaping Applied to the Surgical Area on Pain, Mobilization, Sleep, and Patient Satisfaction.
Study Overview
Status
Conditions
Detailed Description
The study population consisted of patients who underwent orthopedic surgery at the Orthopedic Clinics of Van Training and Research Hospital between February 2024 and August 2024. The sample consisted of patients who met the inclusion criteria and agreed to participate in the study. The study sample size was calculated using the G*power 3.1.9.2 program. The power analysis determined that a 0.40 effect size (Cohen 2013), 80% power, and a margin of error of 0.05 were required, resulting in 120 patients, 40 for each group (Experimental, Control, and Placebo). During the data collection period, one patient in the intervention group developed an allergy to kinesio tape and developed a rash on her body. The study was completed with 119 patients. Patients scheduled to undergo soft tissue surgery in the orthopedic wards who met the inclusion criteria were identified. The study was conducted in a single-blind, randomized manner. Patients were assigned to either the experimental, control, or placebo groups.
33 The simple randomization method, implemented on the www.randomizer.org website, was used to determine whether they would be included in the study. Numbers between 1 and 120 were randomized into the three groups using randomizer.org.
The study sample consisted of 120 patients who met the inclusion criteria. However, one patient developed an allergic reaction at the postoperative kinesiotape application site and was excluded from the study, resulting in a total of 119 patients. The patient's group was determined based on the number they were assigned to, and procedures specific to the group they were assigned to were performed during the surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Erzurum, Turkey (Türkiye), 25000
- Büşra ERCAN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 and over
- Patients without visual or hearing problems
- Patients who can speak and understand Turkish
- Patients who volunteer to participate in the study
- Patients who do not have a problem that would prevent the application of kinesio tape
Exclusion Criteria:
- Patients who develop an allergic reaction after the application of kinesio tape
- Patients who show abnormalities in their vital signs and develop complications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: kinesio taping was applied to the post-operative area.
Patients will fill out a patient introduction form before surgery.
Kinesiotape will be applied at 8 hours after surgery and the Visual Analog Scale will be filled.
Visual Analog Scale will be applied and recorded at 8, 9, 10, 12 and 24 hours.
Richards-Campbell Scale will be applied at 24 hours.
Patient Mobilization Scale will be applied at 12. and 24.
hours.
Patient Satisfaction-Quality of Recovery Scale (QoR-40) will be applied at 24. hours.
|
Investigation of the effects of kinesio taping applied to the surgical area after surgery on patients' pain, sleep, and mobility.
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Placebo Comparator: A tape similar to kinesio tape was applied to the surgical area.
Patients will fill out a patient introduction form before surgery.A kinesio tape-like bandage will be applied 8 hours after the surgery and the Visual Analog Scale will be filled in.
The Visual Analog Scale will be applied and recorded at 8, 9, 10, 12 and 24 hours.
The Richards-Campbell Scale will be applied at 24 hours.
The Patient Mobilization Scale will be applied at 12 and 24 hours.
The Patient Satisfaction-Quality of Recovery Scale (QoR-40) will be applied at 24 hours.
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To examine the effects on a patient's pain, sleep, and mobility after applying a tape with a similar shape to kinesiotape to the surgical area after surgery, thereby creating a placebo effect.
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No Intervention: NO POST-OP INTERVENTION
Patients will fill out a patient introduction form before surgery.
No post-operative interventions.Visual Analog Scale will be applied and recorded at 8, 9, 10, 12 and 24 hours.
Richards-Campbell Scale will be applied at 24 hours.
Patient Mobilization Scale will be applied at 12 and 24 hours.
Patient Satisfaction-Quality of Recovery Scale (QoR-40) will be applied at 24 hours.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Introduction Form
Time Frame: Before or on the day of surgery
|
It consists of questions regarding the demographic characteristics of the patient, surgical intervention and kinesiotape application, prepared by the researcher for the purpose of collecting research data.
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Before or on the day of surgery
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Visual Analog Scale
Time Frame: Up to 24 hours after surgery
|
The visual analog scale is the most commonly used tool for both estimating the intensity of pain and judging the degree of pain relief.
The healthcare professional asks the patient to select a point on a line drawn between two extremes to indicate how intense the pain is perceived.
The VAS is a continuous scale, usually consisting of a horizontal (HVAS) or vertical (VVAS) line 100 mm long and anchored by two verbal descriptors (i.e., "no pain" and "worst imaginable pain").
Patients are asked to rate either the "current" pain intensity or the pain intensity "over the past 24 hours."
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Up to 24 hours after surgery
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Patient Mobility Scale
Time Frame: Up to 12th and 24th hours after surgery
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The "pain and difficulty level" experienced by the patient during four activities performed post-op (turning from one side to the other in bed, sitting on the edge of the bed, standing up on the edge of the bed, and walking in the patient room) can be evaluated with a 15 cm visual analog scale with verbal expressions below the scale.An increase in the scale score indicates increased pain and difficulty performing the movement depending on the activity.
Conversely, a decrease in the score indicates a decrease in the pain and difficulty patients experience while performing the four movements.
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Up to 12th and 24th hours after surgery
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Richards-Campbell Sleep Scale
Time Frame: Up to 24 hours after surgery
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The scale has a 100 mm line with words describing the worst possible sleep (0 mm) and the best possible sleep (100 mm).
When calculating the total score of the scale, the scores obtained from the 5 items are added; the 6th item, which evaluates the noise level in the environment, is not included in the total score calculation.
The sum of the five items gives the total sleep quality score.
As the scale score increases, the sleep quality of the patients also increases.
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Up to 24 hours after surgery
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Patient Satisfaction-Recovery Quality Scale
Time Frame: Up to 24 hours after surgery
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It is a Likert type test consisting of 5 parts and 40 questions.
It includes 9 questions to evaluate the patient's emotional state, 12 questions to evaluate physical comfort, 7 questions to evaluate psychological support, 5 questions for physical dependency and 7 questions to determine the level of pain.
The survey score is between 40-200.
The score is directly proportional to patient satisfaction.
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Up to 24 hours after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zeynep KARAMAN ÖZLÜ, Prof.Dr., Ataturk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Bercan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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