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Surgery and Functionality in Older Adults (SFO)

Primary Purpose

Fear, Movement Disorder, Functional, Kinesiophobia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
therapatic Foot massaje (sweden technic)
Sponsored by
University of Yalova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fear

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Asuman Saltan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Massage group

Control group

Arm Description

The group will have a foot massage.

The group will not have any intervention.

Outcomes

Primary Outcome Measures

Decreased Kinesiophobia
Measures will doing with Tampa scale of kinesiophobia.

Secondary Outcome Measures

Decreased Pain
Measures will doing with Visual Analog Scale

Full Information

First Posted
September 4, 2022
Last Updated
March 26, 2023
Sponsor
University of Yalova
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1. Study Identification

Unique Protocol Identification Number
NCT05534490
Brief Title
Surgery and Functionality in Older Adults
Acronym
SFO
Official Title
The Investigation of the Effect of Foot Massage on the Functionality of Older Adults After General Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
September 6, 2022 (Actual)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Yalova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear, Movement Disorder, Functional, Kinesiophobia, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study, single-blind.
Masking
Care Provider
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Massage group
Arm Type
Experimental
Arm Description
The group will have a foot massage.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The group will not have any intervention.
Intervention Type
Other
Intervention Name(s)
therapatic Foot massaje (sweden technic)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decreased Kinesiophobia
Description
Measures will doing with Tampa scale of kinesiophobia.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Decreased Pain
Description
Measures will doing with Visual Analog Scale
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
asuman saltan
Organizational Affiliation
YU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asuman Saltan
City
Merkez
State/Province
Yalova
ZIP/Postal Code
77400
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Surgery and Functionality in Older Adults

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