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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05471778
Other study ID # 2021-178
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2021
Est. completion date July 15, 2022

Study information

Verified date July 2022
Source Malatya Turgut Ozal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Total knee arthroplasty (TKA) is a surgical procedure used to restore painless joint function and increase patients' activities of daily living in patients with progressive knee osteoarthrosis. Kinesiophobia can be seen in patients suffering from pain. It is stated that the incidence of kinesiophobia in TKA patients is 24.4%. Based on this information, this study was planned.


Description:

Total knee arthroplasty (TKA) is a surgical procedure used to restore painless joint function and increase patients' activities of daily living in patients with progressive knee osteoarthrosis. Kinesiophobia can be seen in patients suffering from pain. It is stated that the incidence of kinesiophobia in TKA patients is 24.4%. Pain etc. While conditions can be relieved by pharmacological treatment methods, non-pharmacological treatments can be effective in relieving patients' pain. With the relief of pain, it will be possible to eliminate the kinesiophobia experienced by the patients. It is known that humor, which is among the non-pharmacological treatment methods, increases the pain resistance of the patients, reduces the stress hormone, and strengthens the immune system. It is reported in the literature that listening to music, another non-pharmacological treatment, is also effective in relieving pain after TKA. For this reason, the study was planned to determine the effect of postoperative music and comedy films on kinesiophobia and pain in patients undergoing TKA.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date July 15, 2022
Est. primary completion date July 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over the age of 18 who agreed to participate in the study, - Patients undergoing TKA - Patients without a disabling psychiatric disorder Exclusion Criteria: - Patients under the age of 18 who do not agree to participate in the study. - Those who have a psychiatric diagnosis that prevents communication.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Watching comedy movie
A 25-minute comedy film created by the researchers was watched.
listening to music
25 minutes of music created by the researchers was played.

Locations

Country Name City State
Turkey Turgut Ozal Medical Center Malatya

Sponsors (1)

Lead Sponsor Collaborator
Malatya Turgut Ozal University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Saritas S, Genç H, Okutan S, Inci R, Özdemir A, Kizilkaya G. The Effect of Comedy Films on Postoperative Pain and Anxiety in Surgical Oncology Patients. Complement Med Res. 2019;26(4):231-239. doi: 10.1159/000497234. Epub 2019 Mar 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Tampa Kinesiophobia Scale (TKS) The kinesiophobia levels of the patients were evaluated postoperatively and 24 hours after surgery. up to 24 hours post-surgery (0-1 day)
Primary Pain Level The pain levels of the patients were measured by means of the visual pain scale. up to 24 hours post-surgery (0-1 day)
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