NCT07452497

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2024

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

September 10, 2024

Last Update Submit

March 4, 2026

Conditions

Keywords

Painkinesiobantsleepsurgical interventionmobilizationsatisfaction

Outcome Measures

Primary Outcomes (5)

  • 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.

    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."

    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.

    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.

    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.

    Up to 24 hours after surgery

Study Arms (3)

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.

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.

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.

Interventions

KinesiotapeBEHAVIORAL

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

kinesio taping was applied to the post-operative area.

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.

A tape similar to kinesio tape was applied to the surgical area.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who develop an allergic reaction after the application of kinesio tape
  • Patients who show abnormalities in their vital signs and develop complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Büşra ERCAN

Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intraoperative ComplicationsPainPersonal Satisfaction

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Zeynep KARAMAN ÖZLÜ, Prof.Dr.

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

September 10, 2024

First Posted

March 5, 2026

Study Start

January 1, 2024

Primary Completion

May 1, 2024

Study Completion

July 30, 2024

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations