Effects of Stress Ball and Hand Holdig on Pain and Mobility Levels During Continuous Passive Motion In Patients With Total Knee Prosthesis: A Randomized Controlled Trial

Summary

Pain after Total Knee Prosthesis (TKA) is an important problemWhen pain is not controlled, it can negatively affect the patients\' mobility level.This research; A randomized controlled experimental design was planned to examine the effects of stress ball and hand holding on pain and mobility levels in patients who underwent Continuous Passive Movement (CPM) after TOTAL knee prosthesis.The study was planned to be conducted between 15.07.2024 and 15.12.2025 on patients who who had total knee prosthesis surgery at the Aksaray University Training and Research Hospital Orthopedics and Traumatology Clinic.Since no study similar to our study design was found in the literature, the sample size of the study was calculated as 22 patients in each arm with Cohen\* effect sizes for VAS, 3 arms, 2 repeated measurements, a medium effect size of 0.25 effect, 95% power and 5% type 1 error level.Considering that there may be data loss in the study, the sample size was increased by 20%, and a total of 78 patients, 26 in each arm.Assignment of patients to stress ball, hand holding and control arm using block randomization method,Determining by drawing lots which letters will represent the stress ball, hand holding and control arms as A, B, C,The blocks were planned to be created by a statistician."Stress ball intervention" to the stress ball arm during continuous passive movement exercise;\"Hand holding intervention\" will be made to the hand holding arm,"No intervention other than standard maintenance" will be made to the control arm.The implementation of the study will be carried out by the researcher R.S. and will be blinded to random assignment.On the 1st and 2nd days after total knee prosthesis, exercises are performed for 30 minutes with continuous passive movement.Considering this situation and the literature, the pain levels of the patients will be evaluated a total of 4 times on the 1st and 2nd days, before the CPM exercise, at the 5th minute, 15th minute and at the end of the exercise (30th minute); Mobility levels will be evaluated at this time, as the patient is mobilized within 1-2 hours after exercise.It was planned to collect the data with the "Patient Questionnaire Form, "Pain Assessment Form", "Patient Mobility Scale" and Observer Mobility Scale".Permission to use the scales was obtained via e-mail. Ethics committee and institution permissions were obtained to start the study.Data will be compared using Pearson chi-square, Fisher exact test, One-way ANOVA and repeated measures ANOVA, Kruskal Wallis test.It was planned to obtain informed consent from the patients before the study.The study is limited by the inclusion of patients with ASA I and II who underwent total knee prosthesis with a single physician and a single surgical technique at the Aksaray University Training and Research Hospital Orthopedics and Traumatology Clinic, regardless of whether they had chronic diseases.The study results can be used in planning the pain management of patients.It is thought that complications that may occur due to delayed mobilization and immobility can be prevented in patients whose pain is reduced.

Conditions

• Pain and Mobility Levels of Patients Undergoing Total Knee Prosthesis During Continuous Passive Motion Exercise

Interventions

OTHER

stress ball intervention

Stress ball intervention; A medium hard, round, high quality stress ball of the same brand will be given to the patient\'s actively used hand 1-2 minutes before starting the continuous passive movement exercise by the researcher.The patient will be asked to squeeze and relax the stress ball for a count of 5 during continuous passive movement.After squeezing the stress ball, the patient should count to 5 and then relax it.The patient will be asked to continue this process until the continuous passive movement exercise is completed.

OTHER

hand holding intervention

Hand holding intervention will be performed by the person the patient prefers. Before the continuous passive movement exercise, the person concerned will sit next to the patient\'s bed and warm their hands at a level that will not disturb the patient.1-2 minutes before the continuous passive motion exercise, the patient will hold the patient\'s hand with one hand, without using gloves, with moderate pressure, without rubbing or squeezing to an uncomfortable level.Hand holding intervention will continue until the continuous passive movement exercise is completed.

Sponsors & Collaborators

• Necmettin Erbakan University

  lead OTHER

Principal Investigators

• Rabia SARI, LECTURER · AKSARAY UNIVERSITY/AKSARAY/TURKIYE

• Saide FAYDALI, Associate Professor · NECMETTIN ERBAKAN UNIVERSITY/KONYA/TURKIYE

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-25

Primary Completion

2025-06-25

Completion

2025-12-25

Countries

• Turkey (Türkiye)

Study Locations