NCT05534490

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

May 8, 2024

Status Verified

March 1, 2024

Enrollment Period

Same day

First QC Date

September 4, 2022

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Decreased Kinesiophobia

    Measures will doing with Tampa scale of kinesiophobia.

    3 weeks

Secondary Outcomes (1)

  • Decreased Pain

    3 weeks

Study Arms (2)

Massage group

EXPERIMENTAL

The group will have a foot massage.

Other: therapatic Foot massaje (sweden technic)

Control group

NO INTERVENTION

The group will not have any intervention.

Interventions

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.

Massage group

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Lying in the service after surgery
  • Being in the age range of 65-75 years -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asuman Saltan

Merkez, Yalova, 77400, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Conversion DisorderKinesiophobia

Condition Hierarchy (Ancestors)

Somatoform DisordersMental DisordersPhobic DisordersAnxiety Disorders

Study Officials

  • asuman saltan

    YU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study, single-blind.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

September 4, 2022

First Posted

September 9, 2022

Study Start

September 6, 2022

Primary Completion

September 6, 2022

Study Completion

November 15, 2024

Last Updated

May 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations