- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05471778
Effects of Music and Comedy Application on Pain and Kinesyophobia in Patients With TKA
July 20, 2022 updated by: Gurkan KAPIKIRAN, Malatya Turgut Ozal University
The Effect of Postoperative Music and Comedy Movie Application on Surgical Pain and Kinesiophobia After Total Knee Artroplasty
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Malatya, Turkey, 44090
- Turgut Ozal Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: comedy movie group
Sociodemographic information form, kinesiophobia scale and numerical pain scale were administered to the patients in the comedy group on the first evening after surgery.
25-minute comedy film was watched.
Afterwards, the kinesiophobia scale and the numerical pain scale were applied again.
|
A 25-minute comedy film created by the researchers was watched.
|
|
Experimental: Music group
Sociodemographic information form, kinesiophobia scale and numerical pain scale were administered to the patients in the music group on the first evening after surgery.
25 minutes of music (nature sound) was played.
Afterwards, the kinesiophobia scale and the numerical pain scale were applied again.
|
25 minutes of music created by the researchers was played.
|
|
No Intervention: Control group
In the follow-up of the patient, no application was made other than clinical protocols.
Sociodemographic information form, kinesiophobia scale and numerical pain scale were administered to the patients in the control group on the first evening after surgery.
No intervention was made.
Afterwards, the kinesiophobia scale and the numerical pain scale were applied again.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Kinesiophobia Scale (TKS)
Time Frame: up to 24 hours post-surgery (0-1 day)
|
The kinesiophobia levels of the patients were evaluated postoperatively and 24 hours after surgery.
|
up to 24 hours post-surgery (0-1 day)
|
|
Pain Level
Time Frame: up to 24 hours post-surgery (0-1 day)
|
The pain levels of the patients were measured by means of the visual pain scale.
|
up to 24 hours post-surgery (0-1 day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gürkan Kapikiran, Ph.D, Malatya Turgut Ozal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2021
Primary Completion (Actual)
July 8, 2022
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
July 19, 2022
First Submitted That Met QC Criteria
July 20, 2022
First Posted (Actual)
July 25, 2022
Study Record Updates
Last Update Posted (Actual)
July 25, 2022
Last Update Submitted That Met QC Criteria
July 20, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2021-178
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthroplasty Complications
-
Hospital for Special Surgery, New YorkMedical College of WisconsinRecruitingComplications; Arthroplasty | Complications; Arthroplasty, MechanicalUnited States
-
Afyonkarahisar Health Sciences UniversityRecruiting
-
Centre Hospitalier Universitaire de NiceCompletedArthroplasty ComplicationsFrance
-
Restor3DCompletedComplications; ArthroplastyUnited States
-
Groupe Hospitalier de la Rochelle Ré AunisCompletedArthroplasty ComplicationsFrance
-
Stryker OrthopaedicsCompleted
-
GCS Ramsay Santé pour l'Enseignement et la RechercheCompletedArthroplasty ComplicationsFrance
-
Central Hospital, Nancy, FranceCompleted
-
Centre Hospitalier Universitaire, AmiensCompletedArthroplasty Complications
-
Norfolk and Norwich University Hospitals NHS Foundation...University of East Anglia; Dynamic Metrics LtdCompletedArthroplasty ComplicationsUnited Kingdom
Clinical Trials on Watching comedy movie
-
Eskisehir Osmangazi UniversityCompletedPain | Rheumatoid Arthritis | Anxiety | Nursing CariesTurkey
-
Gurkan KAPIKIRANCompletedPain | Anxiety | General SurgeryTurkey
-
Inonu UniversityCompletedAcute Pain | Physiological ParameterTurkey
-
Ariel UniversityCompleted
-
Bitlis Eren UniversityCompletedPain, Postoperative | Surgery | Anxiety Postoperative | Care Acceptor, HealthTurkey (Türkiye)
-
Cedars-Sinai Medical CenterCompletedQuality of Life | Breast Neoplasms | DistressUnited States
-
Hospital de Clinicas de Porto AlegreUnknown
-
Universitat Politècnica de CatalunyaHospital Universitari Mutua TerrassaNot yet recruitingStrabismus | Amblyopia
-
Ege UniversityCompletedPain | Postoperative Pain | Surgery | Fear | Nursing Caries | Nurse's Role | Pediatric | Patient | Clinical AnxietyTurkey
-
Leiden University Medical CenterCompletedBlood Coagulation Disorder