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NCT Number: NCT07452497

Investigation of the Effect of Kinesiotape Application to the Surgical Area on Pain, Mobilization, Sleep, and Patient Satisfaction

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

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Key information

Conditions

Intraoperative Complications Behavior Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Büşra ERCAN

Erzurum, 25000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesiotape

Behavioral

Investigation of the effects of kinesio taping applied to the surgical area after surgery on patients' pain, sleep, and mobility.

Post-operative application of adhesive tape to the surgical area that has the same shape and similarity as kinesiotape.

Other

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.

Primary outcomes

  1. 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.

  2. 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."

  3. Patient Mobility Scale

    Time frame: Up to 12th and 24th hours after surgery

    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.

  4. Richards-Campbell Sleep Scale

    Time frame: Up to 24 hours after surgery

    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.

  5. Patient Satisfaction-Recovery Quality Scale

    Time frame: Up to 24 hours after surgery

    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.

Sponsors and collaborators

Lead sponsor

Busra Ercan

Other

Registry information

Official study title

Investigation of the Effects of Kinesiotaping Applied to the Surgical Area on Pain, Mobilization, Sleep, and Patient Satisfaction.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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