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

NCT06523413 | Recruiting

• 1 other identifier: SuleymanDU_SALMAN-F-002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Arthroplasty Complications

Keywords

anxiety; vital signs; artroplasty

Outcome Measures

Primary Outcomes (7)

• State Anxiety Inventory (STAI-I)

  State-Trait Anxiety Inventory (STAI), developed by Spielberger (1970), is a self-assessment questionnaire consisting of short statements created to determine the level of anxiety. The scale consists of 20 items. Answers range from 1-4. The total score obtained from the scale is between 20-80. A high score indicates a high level of anxiety

  The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

• Pain Level

  The intensity of the pain will be quantified using the Visual Analogue Scale (VAS). The scale is evaluated by assigning a score between 0 and 10. On the scale, the absence of pain is indicated by a rating of 0 points, while the most severe pain imaginable is indicated by a rating of 10 points.

  The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

• Temperature

  The temperature of the patients will be measured on the patient's forehead using a digital thermometer. Fever degree will be presented in centigrade (°C).

  The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

• Blood pressure

  Patients' blood pressure will be measured in mmHg using a portable bedside monitor.

  The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

• Heart rate

  Patients' pulses will be measured in beats/minute using a portable bedside monitor.

  The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

• Saturation

  Saturation of patients will be measured in % using a portable bedside monitor

  The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

• Respiratory rate

  The respiratory rate of the patients will be measured by monitoring the patient's chest movements in one minute.

  The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

Study Arms (3)

Intervention Group 1

EXPERIMENTAL

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.

Behavioral: Game activity

Intervention Group 2

EXPERIMENTAL

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.

Device: Stres Ball

Control Group

NO INTERVENTION

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

Interventions

Game activity BEHAVIORAL

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

Intervention Group 1

Stres Ball DEVICE

Patients will use the stress ball for 15 minutes.

Intervention Group 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Isparta Şehir Hastanesi

Isparta, 32200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Filiz Assist. Prof. Filiz Salman Saraç

CONTACT

+90 232 211 3713; filizsalman@sdu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Dr.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 26, 2024
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

TU (1)