NCT05471778

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

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

December 20, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 19, 2022

Last Update Submit

July 20, 2022

Conditions

Keywords

MusicComedy movieKinesiophobiaPainTotal knee arthroplasty

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (3)

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.

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.

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.

Interventions

A 25-minute comedy film created by the researchers was watched.

comedy movie group

25 minutes of music created by the researchers was played.

Music group

Eligibility Criteria

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

You may qualify if:

  • Patients over the age of 18 who agreed to participate in the study,
  • Patients undergoing TKA
  • Patients without a disabling psychiatric disorder

You may not qualify if:

  • Patients under the age of 18 who do not agree to participate in the study.
  • Those who have a psychiatric diagnosis that prevents communication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turgut Ozal Medical Center

Malatya, 44090, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 30921794BACKGROUND
  • Cici 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.

MeSH Terms

Conditions

KinesiophobiaPain

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gürkan Kapikiran, Ph.D

    Malatya Turgut Ozal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was conducted as a randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 19, 2022

First Posted

July 25, 2022

Study Start

December 20, 2021

Primary Completion

July 8, 2022

Study Completion

July 15, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations