Intraoperative ComplicationsNCT07452497
Investigation of the Effect of Kinesiotape Application to the Surgical Area on Pain, Mobilization, Sleep, and Patient Satisfaction
A study testing Kinesiotape and Post-operative application of adhesive tape to the surgical area that has the same shape and similarity as kinesiotape. in people with Intraoperative Complications, run by Busra Ercan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Complications
- What is being tested?
- Kinesiotape and Post-operative application of adhesive tape to the surgical area that has the same shape and similarity as kinesiotape.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who develop an allergic reaction after the application of kinesio tape
- Patients who show abnormalities in their vital signs and develop complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Kinesiotaping Applied 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
Read the 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
- Being tested
- Kinesiotape, Post-operative application of adhesive tape to the surgical area that has the same shape and similarity as kinesiotape.
- Keywords
- Pain, kinesiobant, sleep, surgical intervention, mobilization, satisfaction
- Medical subject headings
- Intraoperative Complications, Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| kinesio taping was applied to the post-operative area. | Experimental | 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. Receives: Behavioral: Kinesiotape |
| A tape similar to kinesio tape was applied to the surgical area. | Placebo comparator | 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. Receives: Other: Post-operative application of adhesive tape to the surgical area that has the same shape and similarity as kinesiotape. |
| NO POST-OP INTERVENTION | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Introduction Form
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.
Measured: Before or on the day of surgery
Visual Analog Scale
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."
Measured: Up to 24 hours after surgery
Patient Mobility Scale
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.
Measured: Up to 12th and 24th hours after surgery
Richards-Campbell Sleep Scale
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.
Measured: Up to 24 hours after surgery
Patient Satisfaction-Recovery Quality Scale
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.
Measured: Up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Busra Ercan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Busra Ercan, Ataturk University
- Investigators
- Zeynep KARAMAN ÖZLÜ, Prof.Dr., Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452497
- Sponsor's protocol ID
- Bercan
- Status last verified
- Mar 2026
- First submitted
- 10 Sep 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Kinesiotaping Applied to the Surgical Area on Pain, Mobilization, Sleep, and Patient Satisfaction.
- ClinicalTrials.gov ID
- NCT07452497
- Acronym / sponsor ID
- Bercan
- Conditions
- Intraoperative Complications
- Keywords
- Pain, kinesiobant, sleep, surgical intervention, mobilization, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Busra ErcanUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| kinesio taping was applied to the post-operative area. | Experimental | Behavioral: KinesiotapePatients 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. |
| A tape similar to kinesio tape was applied to the surgical area. | Placebo comparator | Other: Post-operative application of adhesive tape to the surgical area that has the same shape and similarity as kinesiotape.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. |
| NO POST-OP INTERVENTION | No 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who develop an allergic reaction after the application of kinesio tape
- Patients who show abnormalities in their vital signs and develop complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinesiotapeInvestigation of the effects of kinesio taping applied to the surgical area after surgery on patients' pain, sleep, and mobility. | Behavioural | kinesio taping was applied to the post-operative area. |
| 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. | Other | A tape similar to kinesio tape was applied to the surgical area. |
Primary outcome
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.
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."
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep KARAMAN ÖZLÜ, Prof.Dr. principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape and Post-operative application of adhesive tape to the surgical area that has the same shape and similarity as kinesiotape. in people with Intraoperative Complications, run by Busra Ercan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Introduction Form (time frame: Before or on the day of surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.