Surgery and Functionality in Older Adults (SFO)

The Investigation of the Effect of Foot Massage on the Functionality of Older Adults After General Surgery

When the literature is examined, it has not been found that the use of massage applications in relation to the functional level of individuals who have undergone abdominal surgery. We think that our study will be the first in this field. Therefore, this study will lay the groundwork for future studies on the subject. In the future, it is aimed to establish a standardized evaluation method to determine the functional levels of individuals who have undergone abdominal surgery and to determine the ideal duration and frequency when a decision is made to apply foot massage in the future with the data obtained as a result of this method. In this study, the effectiveness of foot massage on the functional level of individuals with high post-surgical kinesiophobia will be investigated.

Study Overview

• Status: Enrolling by invitation
• Conditions: Surgery; Fear; Kinesiophobia; Movement Disorder, Functional
• Intervention / Treatment: Other: therapatic Foot massaje (sweden technic)

Detailed Description

Pain, delirium, kinesiophobia, balance, mental level, and mobility are factors that express functional level in elderly individuals. It is especially important to regain at least the previous functional level after surgery. Although there are protocols and evaluation methods for returning or regaining the functional level after certain surgeries (for examples orthopedic surgeries such as knee or hip and cardiovascular surgery), admission to the discharge or rehabilitation program, especially after abdominal surgeries within the scope of general surgery. There is no protocol or evaluation method in the literature for the evaluation of situations such as In the studies, it was seen that scales were developed to evaluate the morbidity rate rather than the functional level after general surgery. Therefore, the evaluation of the functional level after surgery will be one of the important steps taken for the discharge or rehabilitation process to start as soon as possible. However, with the applications to reduce the high rate of kinesiophobia, the duration of discharge can be shortened, and rehabilitation can be started more quickly if necessary. With this study, the functional levels of the patients hospitalized in the general surgery service will be evaluated and the effect of foot massage on the functional level will be investigated. With this study, the effectiveness of foot massage on the functional level will be investigated in individuals with high post-surgical kinesiophobia, which is expected to be the first in the literature.

Our hypothesis (H0) is that foot massage after surgery has no effect on the functional level. Our H1 hypothesis is that foot massage has an effect on the functional level.

In light of the above information, in this study, a foot massage (Swedish massage) lasting 20 minutes in total, will be applied to the feet of the patients in the post-surgical service once a day, bilaterally, until discharge. Pain, mental level, delirium status, mobility, kinesiophobia, balance, and functional independence level measurements of the individual will be repeated before and after the massage.

The aim of this study is to investigate the effect of massage on the functional level of elderly individuals in the postoperative period. The study will be carried out between July 2022 and October 2022 in a randomized controlled manner in individuals aged 65-75 years in Kocaeli University Research and Practice Hospital general surgery clinic.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yalova
    • Merkez, Yalova, Turkey, 77400
      • Asuman Saltan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Lying in the service after surgery

Being in the age range of 65-75 years -

Exclusion Criteria:

Using sedative or narcotic drugs

Having vascular problems such as deep vein thrombosis in the feet

Having skin diseases such as ulcers, infections, fungi on the feet

Fracture of lower extremity

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Massage group; The group will have a foot massage.	Other: therapatic Foot massaje (sweden technic); Everything is explained to the individuals on the day of surgery. After the surgery, when the individuals regains consciousness in the service, the Swedish massage technique is applied bilaterally for 10 minutes. In addition to the demographic data of the patient before the application and in the preoperative period; pain, mental level, delirium status, mobility, kinesiophobia, balance, and functional independence level measurement evaluations are made. Massage is continued for a total of 20 minutes, 10 minutes for each foot, once a day until the patient is discharged. The measurements are repeated on the day the individual will be discharged.
No Intervention: Control group; The group will not have any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased Kinesiophobia	Measures will doing with Tampa scale of kinesiophobia.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased Pain	Measures will doing with Visual Analog Scale	3 weeks

Collaborators and Investigators

• Sponsor: University of Yalova
• Investigators: Principal Investigator: asuman saltan, YU

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): September 6, 2022
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: September 4, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Personality Disorders; Anxiety Disorders; Phobic Disorders; Somatoform Disorders; Histrionic Personality Disorder; Movement Disorders; Conversion Disorder; Hysteria; Kinesiophobia
• Other Study ID Numbers: KAD001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No