NCT05651048

Brief Summary

The literature indicates that postoperative pulmonary complications are seen when pain is not treated effectively after videothoracoscopy surgery (VATS). After surgery, physiotherapy and rehabilitation approaches are applied to prevent complications. Bio-Electro-Magnetic-Energy-Regulation (BEMER) therapy uses low-frequency electromagnetic energy to regulate vasomotion in capillaries and increase microcirculation. BEMER therapy can be applied together with physiotherapy and rehabilitation. The aim of this study is to investigate the effectiveness of BEMER application, which is added to the physiotherapy and rehabilitation program applied after videothoracoscopy surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

November 11, 2022

Last Update Submit

December 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Pain Scores

    Change From Baseline in Pain Scores on the Visual Analog Scale at Postoperative 4th day

    Postoperative 4th day

Study Arms (3)

BEMER Group

EXPERIMENTAL

BEMER application with routine treatment protocol

Other: BEMER Group

Kinesiotape Group

EXPERIMENTAL

Kinesiotape application with routine treatment protocol

Other: Kinesiotape Group

Control Group

EXPERIMENTAL

routine treatment protocol

Other: Control Group

Interventions

Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery

Control Group

BEMER therapy and Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery

BEMER Group

Kinesiotape application and Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery

Kinesiotape Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Presence of pacemaker, severe cardiac failure, severe arrhythmia
  • Those with cooperative disorders
  • Presence of neurological or orthopedic problems affecting the extremities
  • Those with severe psychiatric disorders
  • Failure to perform the operation according to the result of intraoperative tumor staging
  • Patients who go out of the standard Analgesia protocol
  • Patients who were taken back from the service to the intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, 34540, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2022

First Posted

December 14, 2022

Study Start

November 1, 2020

Primary Completion

February 1, 2021

Study Completion

December 20, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations