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Effect of Game Activity and Stress Ball on Anxiety and Vital Signs

NCT ID: NCT06523413

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-05-31

Brief Summary

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This randomized controlled trial aims to determine the effect of game activity and stress ball use on preoperative anxiety and vital signs in patients undergoing total knee arthroplasty. The primary purpose of the study is to evaluate the effect of these methods (game activity, stress ball use) on patients' anxiety and vital signs. The research involves three groups: one group will engage in a game activity, another group will use a stress ball, and the control group will receive no intervention. Patients over 18 years of age who pass the Mini-Cog test, demonstrate cognitive competence and meet other sampling criteria will be included in the study. Data will be collected using the State Anxiety Scale, a vital signs and pain level form, and a descriptive characteristics form.

Detailed Description

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Preoperative anxiety causes various physiological and psychological reactions. In addition, it is known that preoperative anxiety negatively affects the patient's satisfaction with the surgery, the surgical success rate, and the development of postoperative complications. Total knee arthroplasty (TKA) is a surgical procedure frequently performed today to relieve pain and restore knee joint function. Approximately 30% of patients undergoing TKA experience psychological distress before surgery. Anxiety is a problem that needs to be managed in TKA patients because it negatively affects them in the postoperative period.

Interventions such as music, funny videos, massage, meditation, hypnosis, VR glasses, and motivational interviewing have been used to reduce preoperative anxiety in adults. These methods can be applied by nurses, are low cost, and have few side effects. Gaming activities are also one of the methods used to distract patients and reduce their anxiety levels in the preoperative period. The literature shows that game-based approaches in the management of preoperative anxiety are frequently used with pediatric patients. A stress ball is a method used to draw a person's attention in a different direction by squeezing and loosening the ball held in the palm. Although the use of stress balls has not been widely studied in preoperative anxiety management, research shows that stress balls may be useful in anxiety management. Game activity and stress ball use are methods that are easy to implement and will not burden patients in terms of cost.

Conditions

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Anxiety Arthroplasty Complications

Keywords

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anxiety vital signs artroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group 1

The game designated for the group game activity will be played with the patient, the patient's relative, and the researcher before the surgery. Data will be collected by another researcher before the game is played, and measurements will be taken again using data collection tools after the group game activity.

Group Type EXPERIMENTAL

Game activity

Intervention Type BEHAVIORAL

A game determined by the researcher will be played with the patients in the patient room.

Intervention Group 2

Patients will use the stress ball for 15 minutes before surgery. Data will be collected with data collection tools before and after using the stress ball.

Group Type EXPERIMENTAL

Stres Ball

Intervention Type DEVICE

Patients will use the stress ball for 15 minutes.

Control Group

No intervention will be performed on patients. Data will be collected twice before surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Game activity

A game determined by the researcher will be played with the patients in the patient room.

Intervention Type BEHAVIORAL

Stres Ball

Patients will use the stress ball for 15 minutes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Being over 18 years old Undergoing total knee arthroplasty Having passed the Mini-Cog test Ability to understand, read, and write Turkish No hearing or speech problems Having a person accompanying the patient

Exclusion Criteria

Not wanting to participate in the research Unstable general condition Sudden change in vital signs Having a psychological disorder and using antidepressant medication Having any psychiatric or cognitive/mental disease (e.g., dementia) Use of psychiatric medication for any reason
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suleyman Demirel University

OTHER

Sponsor Role lead

Responsible Party

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Filiz Salman Saraç

Research Assistant Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Isparta Şehir Hastanesi

Isparta, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Filiz Assist. Prof. Filiz Salman Saraç

Role: CONTACT

Phone: +90 232 211 3713

Email: [email protected]

Facility Contacts

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Assist. Prof. Filiz Salman Saraç

Role: primary

Other Identifiers

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SuleymanDU_SALMAN-F-002

Identifier Type: -

Identifier Source: org_study_id