Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05534490 |
| Other study ID # |
KAD001 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 6, 2022 |
| Est. completion date |
November 15, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
University of Yalova |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
