Arthroplasty ComplicationsNCT05471778
Effects of Music and Comedy Application on Pain and Kinesyophobia in Patients With TKA
A study testing Watching comedy movie and listening to music in people with Arthroplasty Complications and Kinesiophobia, run by Malatya Turgut Ozal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty Complications, Kinesiophobia
- What is being tested?
- Watching comedy movie and listening to music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2021to 15 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 who agreed to participate in the study,
- Patients undergoing TKA
- Patients without a disabling psychiatric disorder
Who cannot join
- Patients under the age of 18 who do not agree to participate in the study.
- Those who have a psychiatric diagnosis that prevents communication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthroplasty Complications, Kinesiophobia
- Being tested
- Watching comedy movie, listening to music
- Keywords
- Music, Comedy movie, Kinesiophobia, Pain, Total knee arthroplasty
- Medical subject headings
- Kinesiophobia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching comedy movieBehavioural
A 25-minute comedy film created by the researchers was watched.
listening to musicBehavioural
25 minutes of music created by the researchers was played.
| Study group | Role | What they receive |
|---|---|---|
| comedy movie group | Experimental | 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. Receives: Behavioral: Watching comedy movie |
| Music group | Experimental | 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. Receives: Behavioral: listening to music |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Tampa Kinesiophobia Scale (TKS)
The kinesiophobia levels of the patients were evaluated postoperatively and 24 hours after surgery.
Measured: up to 24 hours post-surgery (0-1 day)
Pain Level
The pain levels of the patients were measured by means of the visual pain scale.
Measured: up to 24 hours post-surgery (0-1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start20 Dec 2021
- Primary completion8 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty 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
- Model description
- This study was conducted as a randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malatya Turgut Ozal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurkan KAPIKIRAN, Malatya Turgut Ozal University
- Investigators
- Gürkan Kapikiran, Ph.D, Principal investigator, Malatya Turgut Ozal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471778
- Sponsor's protocol ID
- 2021-178
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saritas S, Genc H, Okutan S, Inci R, Ozdemir 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.
PubMed 30921794Cici R, Bulbuloglu S, Kapikiran G. Effect of meditation music and comedy movie interventions on postoperative kinesiophobia and pain in patients undergoing total knee arthroplasty. ANZ J Surg. 2023 Jan;93(1-2):302-309. doi: 10.1111/ans.18209. Epub 2022 Dec 14.
PubMed 36515211
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postoperative Music and Comedy Movie Application on Surgical Pain and Kinesiophobia After Total Knee Artroplasty
- ClinicalTrials.gov ID
- NCT05471778
- Acronym / sponsor ID
- 2021-178
- Conditions
- Arthroplasty Complications, Kinesiophobia
- Keywords
- Music, Comedy movie, Kinesiophobia, Pain, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Malatya Turgut Ozal UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 25 Jul 2022 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study was conducted as a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| comedy movie group | Experimental | Behavioral: Watching comedy movieSociodemographic 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. |
| Music group | Experimental | Behavioral: listening to musicSociodemographic 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18 who agreed to participate in the study,
- Patients undergoing TKA
- Patients without a disabling psychiatric disorder
Key exclusion criteria (2 listed)
- Patients under the age of 18 who do not agree to participate in the study.
- Those who have a psychiatric diagnosis that prevents communication.
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 |
|---|---|---|
| Watching comedy movieA 25-minute comedy film created by the researchers was watched. | Behavioural | comedy movie group |
| listening to music25 minutes of music created by the researchers was played. | Behavioural | Music group |
Primary outcome
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.
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.
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 25 Jul 2022.
- Background: PubMed 30921794Saritas S, Genc H, Okutan S, Inci R, Ozdemir 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.
- Derived from this study: PubMed 36515211Cici R, Bulbuloglu S, Kapikiran G. Effect of meditation music and comedy movie interventions on postoperative kinesiophobia and pain in patients undergoing total knee arthroplasty. ANZ J Surg. 2023 Jan;93(1-2):302-309. doi: 10.1111/ans.18209. Epub 2022 Dec 14.
- Individual participant dataSharing planned: No
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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.
Gürkan Kapikiran, Ph.D principal investigator
Malatya Turgut Ozal 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 Watching comedy movie and listening to music in people with Arthroplasty Complications and Kinesiophobia, run by Malatya Turgut Ozal University 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 3 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 25 Jul 2022. 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. 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?
Tampa Kinesiophobia Scale (TKS) (time frame: up to 24 hours post-surgery (0-1 day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05471778, which also lists 2 linked publications.
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 25 Jul 2022.