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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Busra Ercan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to examine the effect of kinesio tape application applied to the surgical area after soft tissue surgery performed in orthopedic services on pain reduction, sleep quality, mobilization, and patient satisfaction. The study will be completed with 120 participants, divided into 40 experimental, 40 control, and 40 placebo subjects. A simple randomization method will be used to provide an equal number of samples in the three groups, where patients will be asked to choose a number from a bowl containing numbers 1-120. Patients will be interviewed the day before or on the morning of the surgery, educated about the procedures, and written consent will be obtained. During the collection of postoperative pain data, an 8-hour waiting period will be applied to account for the effects of painkillers and anesthetics, and the first VAS (Visual Analog Scale) measurement will be made at the 8th hour. Kinesio tape will be applied to the experimental group at the 8th hour, and since the literature suggests a 45-minute wait for the effect of kinesio tape, the second measurement will be made at the 9th hour; subsequent measurements will be taken at the 10th, 12th, and 24th hours. Similar procedures will be applied to the placebo group using a plaster tape in an ineffective manner, while no intervention will be applied to the control group; both tapes will be kept on for 24 hours and removed after the last measurement. Sleep status will be evaluated using the RCSQ (Richards-Campbell Sleep Questionnaire) 24 hours after surgery. Mobilization, including in-bed mobility and walking, will be evaluated using the Patient Mobility Scale at the 12th and 24th hours. Finally, patient satisfaction and quality of recovery will be assessed using the QoR-40 scale in all three groups at 24 hours after surgery

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.

Conditions

• Intraoperative Complications

Interventions

Type	Name	Description
BEHAVIORAL	Kinesiotape	Investigation of the effects of kinesio taping applied to the surgical area after surgery on patients' pain, sleep, and mobility.
OTHER	Post-operative application of adhesive tape to the surgical area that has the same shape and similarity as kinesiotape.	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-05-01
• Completion: 2024-07-30
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: Turkey (Türkiye)