The Effect of the Web-Based Gamified Application on Functional Results and Recovery Conditions

NCT07053241 | Recruiting DMC

• 1 other identifier: AAU-4293-2020
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to determine the effect of a mobile-compatible web-based gamified application (Game-App-KNEE) developed for post-operative care of total knee replacement (TKA) surgery on functional outcomes and recovery status. Based on this, the hypotheses of our project are; In the intervention group where the mobile-compatible web-based gamified application to be developed for the home care of individuals undergoing TKA due to osteoarthritis is applied, compared to the control group; Hypothesis 1 (H1): After the application of Game-App-KNEE, the functional levels of individuals in the intervention group are higher than the control group. Hypothesis 2 (H1): After the application of Game-App-KNEE, the post-operative recovery levels of individuals in the intervention group are higher than the control group. Participants: Receive the game module application (intervention group) or only the educational booklet (control group) every day for 3 months after discharge Visit the clinic every 1st and 3rd month for check-ups and tests.

Conditions

Postoperative Recovery; Functional Outcome

Keywords

Postoperative recovery; Functional outcome; Total knee arthroplasty; Surgical nursing; Education programme; Rehabilitation; Gamification; Mobile application; Web-based; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Functional Results

  WOMAC is a valid and reliable index widely used for the evaluation of patients with osteoarthritis. It is a recommended measure for osteoarthritis studies by the Rheumatology Clinical Trials Outcome Measures (OMERACT). The WOMAC Osteoarthritis Index, the validity and reliability of which was performed in Turkey, consists of three sub-dimensions and 24 questions questioning pain, stiffness and physical function. The maximum scores that can be obtained from the index are 20 for the pain sub-group, 8 for stiffness and 68 for physical function. The total Cronbach alpha coefficients for the three sub-dimensions at Time 1 and 2 were determined as pain: 0.75, 0.81; stiffness: 0.71, 0.76; physical function: 0.94, 0.96. High scores indicate increased pain and stiffness and deterioration in physical function.

  preoperative period, 1st month postoperatively, 3rd month postoperatively

• Postoperative Recovery Status

  The Postoperative Recovery Index, tested for validity and reliability, consists of 37 items. It has 5 sub-dimensions: psychological symptoms, physical activities, general symptoms, bowel and appetite symptoms. The scores of the items in the sub-dimensions are added up, their means are calculated, and the sub-dimension scores are determined. For the total PoRI score, all 37 items are added up and their means are calculated. High scores from the index indicate that there are more problems in post-operative recovery, while low scores indicate that post-operative recovery is easier. The internal consistency Cronbach's alpha coefficient of the original scale was determined as 0.95. The internal consistency Cronbach's alpha coefficient of the scale, whose Turkish validity and reliability were performed , was determined as 0.97. In addition, it was determined that the five-factor structure of PoRI-TR, which

  the day after surgery, 1st month postoperatively, 3rd month postoperatively

Study Arms (2)

Intervention Group

EXPERIMENTAL

Game Module + Education Booklet Module

Device: Game-App-KNEE

Control Group

PLACEBO COMPARATOR

Education Booklet Module

Other: Control group (standart care)

Interventions

Game-App-KNEE DEVICE

* In the outpatient clinic phase of the study, the purpose of the study will be explained to individuals who meet the inclusion criteria. * The mobile-compatible web-based gamified application created for individuals included in the intervention group will be downloaded to patients' phones in the outpatient clinic phase and information will be provided on how to use the application, and the training will be repeated if they have questions. * Individuals in the intervention group will be able to access both the education module in PDF format and the game module containing the gamified education program for three months in the application. * In-app reminder messages will be sent to individuals to actively use the application. (We missed you today, warrior, where are you, let's finish this job, etc.) * Whether the application is actively logged in, how long it is in the application, and the level of success in the game will be monitored by the researcher from the administrator panel.

Intervention Group

Control group (standart care) OTHER

Description: In the outpatient clinic phase of the study, the purpose of the study will be explained to individuals who meet the inclusion criteria. -An application will be installed on the phones of individuals included in the control group during the outpatient clinic phase. -In the first information phase, individuals will be registered to the system with their username and password by the researcher via their smartphones or tablets and will be allowed to enter the application. Considering that the participant may forget their username and password, a 'forgot my password' button will be added. -Individuals in the control group will only be able to access the training module in PDF format for three months.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to read and write Turkish
• Must have internet access
• Must have a mobile compatible smartphone (IOS, Android)
• Must be able to use a smartphone
• Must be between the ages of 18-65

You may not qualify if:

• Having vision or hearing problems
• Having a mental illness
• Performing bilateral surgery
• Applying general anesthesia
• Having emergency surgery
• Revision surgery during the follow-up period
• Wanting to leave the study

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ebru KARAZEYBEK

  Akdeniz University

  STUDY DIRECTOR

• Sadullah TURHAN

  Mİnİstry of Health of the Republıc of Türkiye

  STUDY DIRECTOR

Central Study Contacts

Cafer OZDEMIR

CONTACT

+905069665581; cozdemir@akdeniz.edu.tr

Cafer OZDEMIR

CONTACT

+905069665581; ozdemircafer88@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The intervention and control groups will be given an explanation of the study independently after discharge. Both groups will have access to the application. However, only the intervention group will have access to the game module.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-blind pre-test-post-test measurement, follow-up, and single-center randomized controlled design.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: July 8, 2025
• Study Start: November 12, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)