- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03915093
Effect of Prehabilitation Protocol on Quality of Life After Thoracoscopic Surgery (VATS)
April 11, 2019 updated by: Maha Nafady Abd El Hafez, Assiut University
Thoracoscopic Surgery: Effect of Designing and Implementing Educational Nursing Protocol on Patients Quality of Life
video-assisted thoracic surgery (VATS) is a new approach used in cardio thoracic surgery department instead of thoracotomy to treat several diseases.patients
underwent thoracoscopic surgery without organized educational protocol either before or after the procedure.
Therefore, this study will be the first clinical research which will increase patients' knowledge about thoracoscopy and decrease its complications.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The role of thoracic nursing specialty is to support and educate patients, who are suffering from thoracic diseases, to achieve the best outcome in terms of physical, psychological, social and spiritual well beings.
The care provided not only focuses on in-hospital treatments that patient received, but also encompasses the whole patient journey including lifestyle modification, health concept promotion, self-empowerment and secondary prevention.
Preoperative prophylactic physiotherapy has been shown to be an important and effective approach in preventing or reducing postoperative complications, in addition to optimizing treatment by familiarizing the patient with the physiotherapeutic procedures.
Quasi experimental research design was utilized to conduct this study.Sixty adult patients undergoing thoracoscopic surgery included and had the following criteria, the age ranged from 18-65 years old, both male and female.
The patients divided into two equal groups (study and control groups), 30 patients for each.
The study group received educational nursing protocol while the control group received the routine hospital care.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt
- Assiut U
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who undergoing thoracoscopic surgery
- Age 18-65 year
- patients who agree to participate in the study
Exclusion Criteria:
- converting to thoracotomy
- patients refuse to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
receive educational nursing protocol
|
It is a booklet given to study group ,which contains Knowledge and practice about thoracoscopy, pre - post operative care and home care instructions
The routine care given by physicians and nurses after thoracoscopic surgery
|
Active Comparator: control group
receive routine hospital care
|
The routine care given by physicians and nurses after thoracoscopic surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of prehabilitation on quality of life after thoracoscopic surgery
Time Frame: after one month postoperative
|
WHOQOL developed by WHO (2004).
It contains 5 broad domains of QOL within which 18 facets are covered to determine the quality of life.
These 5 domains include physical, social, psychological, environmental and perceived QOL.
Within each domain several sub domains (facets) of QOL Summarize that particular domain of QOL.The scoring of these variables, a 3-point lickert scale on tables was adopted for the answer low QOL=0-3, moderate QOL=4-6, and high QOL =7-9.
|
after one month postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effect of prehabilitation on duration of hospital stay after thoracoscopic surgery
Time Frame: immediate post operative
|
assess length of hospital stay postoperative for both groups
|
immediate post operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hussein El Khayat, Faculty of Medicine
- Study Director: Sahra Azer, Faculty of Nursing
- Study Director: Magda Mohamed, Faculty of Nursing
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yeung WW. Post-operative care to promote recovery for thoracic surgical patients: a nursing perspective. J Thorac Dis. 2016 Feb;8(Suppl 1):S71-7. doi: 10.3978/j.issn.2072-1439.2015.10.68.
- Gao K, Yu PM, Su JH, He CQ, Liu LX, Zhou YB, Pu Q, Che GW. Cardiopulmonary exercise testing screening and pre-operative pulmonary rehabilitation reduce postoperative complications and improve fast-track recovery after lung cancer surgery: A study for 342 cases. Thorac Cancer. 2015 Jul;6(4):443-9. doi: 10.1111/1759-7714.12199. Epub 2014 Dec 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2017
Primary Completion (Actual)
December 20, 2018
Study Completion (Actual)
December 20, 2018
Study Registration Dates
First Submitted
April 10, 2019
First Submitted That Met QC Criteria
April 11, 2019
First Posted (Actual)
April 16, 2019
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 11, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 1562017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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