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临床试验/NCT07126340
NCT07126340已完成不适用

The Effect of Foot Massage on Pain, Satisfaction, and Analgesic Consumption in Patients Undergoing Total Knee Arthroplasty

Alev Keskin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Alev Keskin
入组人数
60
试验地点
2
主要终点
Numeric Rating Scale,

研究概览

简要总结

This randomized controlled trial aims to examine the effects of foot massage combined with cold application on postoperative pain, patient satisfaction, and analgesic consumption in individuals undergoing Total Knee Arthroplasty (TKA). The study will be conducted in the Orthopedics and Traumatology Department of Çukurova University Balcalı Hospital, which includes an 18-bed orthopedic unit.

Eligible patients will be randomly assigned to either the intervention group or the control group.

  • Intervention group: Patients will receive both cold application and foot massage. Cold therapy will be administered for 20 minutes every 2 hours for the first 48 hours postoperatively. Foot massage will be performed twice daily (morning and evening) for two days following drain removal, using standardized massage techniques.
  • Control group: Patients will receive only cold application following the same schedule and procedure as the intervention group.

Data will be collected using the Patient Information Form, the Short Form of the Brief Pain Inventory, the Numeric Rating Scale, and the Newcastle Satisfaction with Nursing Care Scale. Statistical analyses will be conducted using SPSS, and findings will be interpreted at a 95% confidence level (p < 0.05).

Ethical approval has been granted by the Çukurova University Non-Interventional Clinical Research Ethics Committee. Institutional permission will be obtained prior to data collection. Participation will be voluntary, and all data will be treated confidentially.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being 18 years or older
  • Ability to speak Turkish
  • No visual or hearing impairment
  • No cognitive disability
  • Undergoing unilateral knee replacement surgery
  • Volunteering to participate in the study
  • Being performed by the same doctor
  • Patients who received regional anesthesia (spinal or epidural) during surgery

排除标准

  • Presence of any intellectual disability or psychiatric disorder
  • History of diabetes
  • Presence of neurological or cerebrovascular disease
  • Diagnosis of deep vein thrombosis

研究组 & 干预措施

Effect of Foot Massage and Cold Application on Postoperative Pain

Active Comparator

The cold application protocol will be initiated upon the patient's arrival at the clinic after surgery. Cold therapy will be applied for 20 minutes every two hours and will continue for 48 hours postoperatively. In addition to cold therapy, patients will receive foot massage performed according to a standard technique. The massage will include effleurage (stroking and gliding), petrissage (kneading), and friction maneuvers. Vaseline will be used during the massage to minimize skin friction and facilitate smooth hand movements.

干预措施: Foot Massage and Cold Application (Other)

Effect of Cold Application on Postoperative Pain

Active Comparator

The cold application protocol will be started from the moment the patient comes to the clinic after surgery. Cold application will be done for 20 minutes and every 2 hours. This application will be continued for the patient for 48 hours from the postoperative period.

干预措施: Cold Application (Other)

结局指标

主要结局

Numeric Rating Scale,

时间窗: One minute

The patient is asked to choose the number that best reflects the pain intensity, 0=no pain, 10= equal to the worst (unbearable) pain.

Numeric Rating Scale,

时间窗: One minute

The patient is asked to choose the number that best reflects the pain intensity, 0=no pain, 10= equal to the worst (unbearable) pain.

Brief Pain

时间窗: Five minutes

The inhibition of individuals' daily living activities due to pain experienced in the last 24 hours is similarly assessed using a numerical scale (0 = not affected at all, 10 = completely affected).

次要结局

  • Newcastle Nursing Satisfaction Scale(Ten minutes)

研究者

发起方
Alev Keskin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alev Keskin

RN, MSc Nurse

Cukurova University

研究点 (2)

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