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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05950217
Other study ID # Nurse_Kinesiophobia02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date May 29, 2024

Study information

Verified date July 2023
Source Karadeniz Technical University
Contact Bahar Candas Altinbas, PhD
Phone +90 545 9125343
Email baharcandas88@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Providing information to the patient before surgery has important effects on the patient's self-care skills regarding the treatment and care process, reducing stress and reducing fears in the postoperative period. The primary aim of this study was to examine the effect of preoperative education on kinesiophobia in patients undergoing total knee replacement surgery. In addition, preoperative anxiety levels, time of first postoperative mobilization, number of steps in the first 24 hours after mobilization and pain levels of the patients will be evaluated as secondary outcomes.


Description:

Kinesiophobia is known as the minimization of activities or avoidance of movement due to the fear that the pain caused by movement will negatively affect the person's life and the problem will occur again. It was first defined by Miller, Kopri and Todd in 1990 at the American Pain Society meeting as excessive and unreasonable anxiety against physical movement and pain in the person, which occurs due to the person feeling vulnerable as a result of a painful injury or re-injury. Kinesiophobia is one of the factors that contribute to the chronicization of pain in individuals after surgery; it can lead to negative patient behaviors on the disease in the surgical process. In addition, kinesiophobia can lead to movement limitation and movement limitation can lead to pain. Since this vicious cycle may result in more pain and disability, the importance of the issue is increasing. It has also been shown that patients with high levels of kinesiophobia experience more pain and have a lower quality of life. This research project aims to provide an original approach in a field where studies on preventing or minimizing the effects of kinesiophobia on the surgical process and postoperative recovery process are limited. It is expected that nurses' interventions for kinesiophobia during the operation process will have positive effects on treatment and care. In this study, visual material-supported patient education will be provided to reduce the level of kinesiophobia associated with total knee replacement surgery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date May 29, 2024
Est. primary completion date December 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 65 years of age or older - Planned surgery - Speaking and understanding Turkish - Being admitted to the hospital at least one day before the surgery Exclusion Criteria: - Visual, hearing and speech disabilities, - Being mentally disabled, - Having a psychiatric disorder or being in the process of treatment - Having had knee replacement surgery before

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education
Nurse-led patient education

Locations

Country Name City State
Turkey Bahar Candas Altinbas Trabzon
Turkey Nurdan Reis Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kinesiophobia Self reported kinesiophobia intensity after surgical process that includes one day after surgery. TAMPA Kinesiophobia Scale (TSK) will be used to evaluate the kinesiophobia. The TSK consists of 17 items that are rated on a 4-point Likert scale, ranging from "Strongly Disagree" to "Strongly Agree." It is scored by assigning a numerical value to each response. Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. 2 days
Secondary Anxiety level Self reported anxiety intensity before surgical process that includes on the day of surgery. State-Trait Anxiety Inventory will be used to evaluate the anxiety. The higher the score is the more anxiety. 2 days
Secondary Pain level It means that what is the severity of the pain that the patients had in 24 hours after surgery. It evaluated with Visual Analog Scale. The most common style used in pain measurement uses a horizontal line measuring exactly 10 cm. The patient is asked to make a mark on this line (from 0 to 10), then the line is measured and recorded in millimeters or centimeters. The higher the score is the more severe the pain. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups. 1 day
Secondary First postoperative mobilization time How many hours after surgery did the patients walk for the first time? This metric will be recorded as day using a questionnaire. The minimum, maximum, median, 25th, and 75th quartiles were calculated for each group and compared. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups. 1 day
Secondary Number of steps in the first 24 hours after mobilization How many steps did the patients take in 24 hours after surgery? This parameter will be evaluated with a pedometer bracelet to be worn on the arm of the patients. The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups. 1 day
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