Effect of Foot Massage on Pain and Analgesic Consumption in Total Knee Prosthesis (NCT07126340) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Foot Massage on Pain and Analgesic Consumption in Total Knee Prosthesis
Turkey (Türkiye)60 participantsStarted 2025-08-18
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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
Exclusion Criteria
* Presence of any intellectual disability or psychiatric disorder
* History of diabetes
* Presence of neurological or cerebrovascular disease
* Diagnosis of deep vein thrombosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is looking at whether foot massage can reduce pain and the need for pain medication after total knee replacement surgery — given that I'm considering or recovering from this procedure, is this kind of non-drug approach something my care team would support me exploring?
2The study is measuring pain using the Numeric Rating Scale and the Brief Pain Inventory — can you help me understand what level of pain reduction would actually be meaningful for my recovery, so I know how to evaluate whether this type of intervention is working for me?
3Since this trial is listed as 'Phase NA,' which often applies to non-drug studies like massage therapy, what does that mean for what's already known about the safety and effectiveness of foot massage as a post-operative pain management tool?
4If I were to discuss joining this trial, how might participating in a massage-based study affect my standard post-surgical pain management plan, and would I still have full access to my usual prescribed pain medications?
5Would you recommend I pursue my standard post-knee-replacement pain management first, or is this the kind of complementary therapy study that could realistically be combined with my regular recovery care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.