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

NCT06608264 | Not Yet Recruiting

• 1 other identifier: 0517010149157
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pain, Knee Prosthesis, Patient Moving and Lifting, Nursing Care, Continuous Passive Motion Therapy.

Outcome Measures

Primary Outcomes (2)

• pain levels

  The pain level of the patients will be evaluated with Visual Analogue Scale (VAS)

  Pain levels of the patients will be evaluated in 4 stages, including the 5th minute, 15th minute and 30th minute of the exercise, before the continuous passive movement exercise between 09:00 and 14:00 on the 1st and 2nd postoperative days.

• Patient Mobility Levels checklist

  Patient mobility levels will be assessed during the mobilization process (position change, sitting, standing up, walking) within 1-2 hours after continuous passive movement exercise,between 09.00-14.00 on the 1st and 2nd day after the surgery

Study Arms (3)

Control arm:

NO INTERVENTION

Patients who did not receive any intervention other than standard treatment and care during continuous passive motion exercise after total knee arthroplasty were defined as the control arm.

stress ball arm

EXPERIMENTAL

Patients who underwent stress ball intervention during continuous passive motion exercise after total knee arthroplasty were defined as stress ball arms.

Other: stress ball intervention

hand holding arm

EXPERIMENTAL

Patients who underwent hand-holding intervention during continuous passive range of motion exercise after total knee arthroplasty were defined as hand-holding arm.

Other: hand holding intervention

Interventions

stress ball intervention OTHER

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.

stress ball arm

hand holding intervention OTHER

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.

hand holding arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• After being informed about the study, written permission was obtained for voluntary participation
• Ages 18 and over
• In the preoperative evaluation, ASA scores were at levels I and II.
• Able to speak Turkish and communicate verbally
• A combination of spinal anesthesia and adductor block was applied during the surgery.
• first time and unilateral total knee prosthesis was performed
• Total knee prosthesis surgery is performed by the same physician and the same surgical technique
• Patients who underwent continuous passive movement exercise after removing the hemovac drain on the first day after surgery were planned to be included in the study.

You may not qualify if:

• Alzheimer\'s, dementia-like conditions that prevent understanding
• Analgesic was administered outside of the analgesic treatment plan determined before continuous passive movement exercise.
• General anesthesia or a different anesthesia is applied during the surgery.
• Patients who stay in the recovery unit for more than 1 hour (more than the routine period) after surgery or who receive treatment and care in the intensive care unit (patients whose vital signs are unstable, who develop lung problems, who are bleeding, who require blood transfusion, who have severe pain)
• Describing pain outside the surgical area
• In the preoperative evaluation, it was planned that patients with ASA scores of III, IV and V would not be included in the study.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Aksaray Training and Research Hospital [Aksaray Eğitim ve Araştırma Hastanesi]

Aksaray, Aksaray/center, 68200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rabia SARI, LECTURER

  AKSARAY UNIVERSITY/AKSARAY/TURKIYE

  PRINCIPAL INVESTIGATOR

• Saide FAYDALI, Associate Professor

  NECMETTIN ERBAKAN UNIVERSITY/KONYA/TURKIYE

  STUDY DIRECTOR

Central Study Contacts

Rabia SARI, LECTURER

CONTACT

+ 90 553 477 5203; rabiasari4268@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In order to prevent assignment bias in the study, blocks will be created by a statistician (in blocks of 6).The letters A, B, C representing the stress ball, hand grip and control arms will be determined by drawing lots.Since the researcher will be with the patient while performing the application, it will not be possible to blind the researcher during the application.However, the consultant will inform the researcher which patient is assigned to which arm once the patient meets the inclusion criteria and gives informed consent.The implementer will be blind to the appointment.The patient will be informed about which intervention (stress ball, hand holding, routine applications) will be performed after this stage. When entering the data into the SPSS database, the researcher will enter the data by coding the branches as A, B, C. Arms will not be reported to the statistician before reporting (blind technique)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Model Details: Type of research:This study was planned as a randomized controlled experimental design to investigate the effects of stress ball and hand grip on pain and mobility levels during continuous passive movement in patients with TKA.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 23, 2024
• Study Start: September 25, 2024
• Primary Completion: June 25, 2025
• Study Completion: December 25, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)