FearSFONCT05534490
Surgery and Functionality in Older Adults
A study testing therapatic Foot massaje (sweden technic) in people with Fear and Movement Disorder, Functional, run by University of Yalova at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Fear, Movement Disorder, Functional, Kinesiophobia
- What is being tested?
- therapatic Foot massaje (sweden technic)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2022to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Lying in the service after surgery
- Being in the age range of 65-75 years -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Fear, Movement Disorder, Functional, Kinesiophobia, Surgery
- Being tested
- therapatic Foot massaje (sweden technic)
- Medical subject headings
- Conversion Disorder, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapatic Foot massaje (sweden technic)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Massage group | Experimental | The group will have a foot massage. Receives: Other: therapatic Foot massaje (sweden technic) |
| Control group | No intervention | The group will not have any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased Kinesiophobia
Measures will doing with Tampa scale of kinesiophobia.
Measured: 3 weeks
Secondary outcomes (1)
Decreased Pain
Measures will doing with Visual Analog Scale
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start6 Sep 2022
- Primary completion6 Sep 2022
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study, single-blind.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asuman saltan, University of Yalova
- Investigators
- asuman saltan, Principal investigator, YU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534490
- Sponsor's protocol ID
- KAD001
- Acronym
- SFO
- Status last verified
- Mar 2024
- First submitted
- 4 Sep 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saltan A, Mert S, Topbas O, Aksu B. The investigation of effect on foot plantar massage on functional recovery in older adults with general surgery, randomized clinical trial. Aging Clin Exp Res. 2024 May 23;36(1):118. doi: 10.1007/s40520-024-02770-2.
PubMed 38780814
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Effect of Foot Massage on the Functionality of Older Adults After General Surgery
- ClinicalTrials.gov ID
- NCT05534490
- Acronym / sponsor ID
- SFO / KAD001
- Conditions
- Fear, Movement Disorder, Functional, Kinesiophobia, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized Controlled Study, single-blind.
| Arm | Type | Receives |
|---|---|---|
| Massage group | Experimental | Other: therapatic Foot massaje (sweden technic)The group will have a foot massage. |
| Control group | No intervention | –The group will not have any intervention. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Lying in the service after surgery
- Being in the age range of 65-75 years -
Key exclusion criteria (5 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Massage group |
Primary outcome
Decreased Kinesiophobia
Time frame: 3 weeks
Measures will doing with Tampa scale of kinesiophobia.
1 secondary outcome
Decreased Pain
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 38780814Saltan A, Mert S, Topbas O, Aksu B. The investigation of effect on foot plantar massage on functional recovery in older adults with general surgery, randomized clinical trial. Aging Clin Exp Res. 2024 May 23;36(1):118. doi: 10.1007/s40520-024-02770-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
asuman saltan principal investigator
YU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapatic Foot massaje (sweden technic) in people with Fear and Movement Disorder, Functional, run by University of Yalova at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased Kinesiophobia (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.