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NCT Number: NCT07126340

Effect of Foot Massage on Pain and Analgesic Consumption in Total Knee Prosthesis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çukurova Üniversitesi

Adana, University, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foot Massage and Cold Application

Other

The patient will receive both cold application and foot massage after total knee arthroplasty.

Cold Application

Other

After total knee arthroplasty, the patient will receive routine cold application.

Primary outcomes

  1. Numeric Rating Scale,

    Time frame: 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.

  2. Brief Pain

    Time frame: 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).

Secondary outcomes

  1. Newcastle Nursing Satisfaction Scale

    Time frame: Ten minutes

    The evaluation of all the items marked on the scale is converted to 100 after the pu moments are collected and made over 0-100 points. The fact that the total score is 100 indicates that all dimensions of nursing care are satisfied.

Sponsors and collaborators

Lead sponsor

Alev Keskin

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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