Stress Ball and Hand Holding on Pain After Knee Arthroplasty

NCT06608264 | Completed

• 2 other identifiers: 0517010149157BAP project no. 24DR9005
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after Total Knee Arthroplasty. (TKA) is an important problem When 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 arthroplasty.The study was planned to be conducted between 03.10.2024 and 09.07.2025 on patients who who had total knee arthroplasty. 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, "Hand holding intervention" will be made to the hand holding arm, "No intervention other than standard maintenance" will be made to the control arm during CPM.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.It was planned to obtain informed consent from patients before the application.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; Total Knee ArthroplastyKnee Pain, Functionality

Keywords

Ambulation, Continuous passive motion therapy, Total Knee Arthroplasty, Nursing care, Pain

Outcome Measures

Primary Outcomes (1)

• Pain levels

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

  Patients' pain levels were assessed in four stages on the 1st and 2nd days post-surgery, between 09:00 and 14:00, before starting continuous passive range of motion exercises, and at the 5th, 15th, and 30th minutes of the exercise.

Secondary Outcomes (2)

• Mobility level assessed using the Patient Mobility Scale

  Postoperative days 1 and 2, during mobilization within 1-2 hours after CPM application.

• Observer-assessed mobility level

  Postoperative days 1 and 2, during mobilization within 1-2 hours after CPM application.

Study Arms (3)

Stress Ball

EXPERIMENTAL

One to two minutes before starting the CPM exercise, the researcher provided the patient with a medium-firm, round, high-quality ball of the same brand for their dominant hand. The patient was instructed to squeeze the ball, count to five, and then release it during the CPM exercise. They were told to continue this process until the CPM exercise was complete.

Behavioral: Stress Ball

Hand Holding

EXPERIMENTAL

Patients were given hand-holding by a person of their choice. Before the CPM exercise, the person holding the patient's hand sat at the patient's bedside and warmed their hands to a level that would not cause discomfort. 1-2 minutes before the CPM exercise, they held the patient's hand with one hand, without gloves, applying moderate pressure without rubbing or squeezing uncomfortably. The hand-holding attempt continued until the CPM exercise was completed.

Behavioral: Hand Holding

Control

NO INTERVENTION

No modifications other than standard maintenance were made to the control arm.

Interventions

Stress Ball BEHAVIORAL

One to two minutes before starting the CPM exercise, the researcher provided the patient with a medium-firm, round, high-quality ball of the same brand for their dominant hand. The patient was instructed to squeeze the ball, count to five, and then release it during the CPM exercise. They were told to continue this process until the CPM exercise was complete.

Stress Ball

Hand Holding BEHAVIORAL

Participants received a hand-holding intervention provided by a person of their own choice. Before the CPM exercise, the designated person sat beside the participant's bed and warmed their hands to a comfortable temperature. One to two minutes before the CPM exercise, they held the participant's hand with one hand, without wearing gloves, applying moderate and comfortable pressure without rubbing or squeezing. Hand holding was maintained continuously throughout the CPM exercise until its completion.

Hand Holding

Eligibility Criteria

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

You may qualify if:

• After being informed about the study, written consent was obtained for voluntary participation
• Able to speak Turkish and communicate verbally.
• Those aged 18 and over
• In the preoperative evaluation, the patient had an American Society of Anesthesiologists (ASA) score of I and II
• A combination of spinal anesthesia and adductor block was applied during the surgery.
• First-ever unilateral total knee arthroplasty performed
• Total knee arthroplasty surgery is performed by the same physician and using the same surgical technique
• Cooperative and oriented
• Patients who underwent CPM placement after removal of the Hemovac drain on day 1 post-surgery were included in the study

You may not qualify if:

• Alzheimer, dementia-like conditions that prevent understanding
• General anesthesia was administered 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)
• Total knee arthroplasty CPM application period after total knee arthroplasty ends earlier than 2 days
• The study investigated complications that developed during the procedure after total knee arthroplasty (such as bleeding or dislocation)
• Patients who decided to withdraw from the study during the implementation phase were planned to be excluded from monitoring/analysis.

Sponsors & Collaborators

• Necmettin Erbakan University: lead
• Aksaray University Training and Research Hospital: collaborator

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Block randomization (blocks of 6) was used to assign participants to study arms. The outcome assessor and statistician were blinded to group allocation. Participants and intervention providers were not blinded due to the nature of the interventions. Group codes (A, B, C) were used for data entry and analysis.
• 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 holding 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: October 3, 2024
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)