The Effect of Stress Ball and Hand Holding on Pain and Mobility Levels During Continuous Passive Movement in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Pain levels
研究概览
简要总结
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.
详细描述
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 total knee arthroplasty..
Research hypotheses:
H0 1: There is no difference in the pain levels of stress ball, hand holding and control arms during CPM in patients with total knee arthroplasty.
H1 1: There is a difference in the pain levels of stress ball, hand holding and control arms during CPM in patients with total knee prosthesis.
H0 2: There is no difference in the mobility levels of stress ball, hand holding and control arms during CPM in patients with total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Patients with hemoglobin levels below 9 g/dL were excluded from the study. Exclusion criteria for monitoring/analysis
- •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.
研究组 & 干预措施
Stress Ball
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.
干预措施: Stress Ball (Behavioral)
Hand Holding
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.
干预措施: Hand Holding (Behavioral)
Control
No modifications other than standard maintenance were made to the control arm.
结局指标
主要结局
Pain levels
时间窗: 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.
The pain level of the patients will be evaluated with Visual Analogue Scale (VAS)
次要结局
- 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.)
研究者
Rabia SARI
LECTURER
Necmettin Erbakan University