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

NCT ID: NCT07126340

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Effect of Foot Massage and Cold Application on Postoperative Pain

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.

Group Type ACTIVE_COMPARATOR

Foot Massage and Cold Application

Intervention Type OTHER

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

Effect of Cold Application on Postoperative Pain

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.

Group Type ACTIVE_COMPARATOR

Cold Application

Intervention Type OTHER

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

Interventions

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Foot Massage and Cold Application

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

Intervention Type OTHER

Cold Application

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

Intervention Type OTHER

Eligibility Criteria

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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

Exclusion Criteria

* Presence of any intellectual disability or psychiatric disorder
* History of diabetes
* Presence of neurological or cerebrovascular disease
* Diagnosis of deep vein thrombosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alev Keskin

OTHER

Sponsor Role lead

Responsible Party

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Alev Keskin

RN, MSc Nurse

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Çukurova Üniversitesi

Adana, University, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Alev Keskin

Role: primary

05465248027 ext. +90

Other Identifiers

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Alev Keskin

Identifier Type: -

Identifier Source: org_study_id