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Enrolling by invitationNCT05534490SFOUpdated May 8, 2024

Surgery and Functionality in Older Adults

An interventional study of therapatic Foot massaje (sweden technic) in Fear, Movement Disorder, Functional and Kinesiophobia, sponsored by University of Yalova. Enrolling by invitation at 1 site in Turkey. Open to participants aged 65 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Yalova · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
65 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fear
  • Movement Disorder, Functional
  • Kinesiophobia
  • Surgery
03

In context

Conversion Disorder

89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.

This study's planned enrollment of 70 is above the median of 38 across 51 interventional studies indexed under Conversion Disorder.

Browse Conversion Disorder studies →

Lead sponsor

University of Yalova is the lead sponsor of 61 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Lying in the service after surgery

Being in the age range of 65-75 years -

Exclusion criteria

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

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Massage group

    The group will have a foot massage.

    Other: therapatic Foot massaje (sweden technic)

  • No intervention
    Control group

    The group will not have any intervention.

Interventions

  • Othertherapatic 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.

06

What researchers measure

Primary outcomes

  1. Decreased Kinesiophobia

    Measures will doing with Tampa scale of kinesiophobia.

    Time frame: 3 weeks

Secondary outcomes

  1. Decreased Pain

    Measures will doing with Visual Analog Scale

    Time frame: 3 weeks

07

Study locations

1 site
  • Asuman Saltan
    Merkez, Yalova 77400, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Sep 2022, 0 months.

Of 34 interventional studies with no phase under Conversion Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2022
First posted
Sep 9, 2022
StartActual
Sep 6, 2022
Primary completionActual
Sep 6, 2022
CompletionEst.
Nov 15, 2024
Last update
May 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05534490
Lead sponsor
University of Yalova
Responsible party
asuman saltan (Associate Proffesor, University of Yalova) — Principal investigator
First posted
Sep 9, 2022
Start date
Sep 6, 2022
Primary completion
Sep 6, 2022
Completion
Nov 15, 2024 (estimated)
Last update
May 8, 2024

Study contacts

asuman saltan
principal investigator · YU

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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