ThoracoscopyVATSNCT03915093
Effect of Prehabilitation Protocol on Quality of Life After Thoracoscopic Surgery
A study testing Educational nursing protocol and Routine hospital care in people with Thoracoscopy and Prehabilitation, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracoscopy, Prehabilitation
- What is being tested?
- Educational nursing protocol and Routine hospital care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2017to 20 Dec 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergoing thoracoscopic surgery
- Age 18-65 year
- patients who agree to participate in the study
Who cannot join
- converting to thoracotomy
- patients refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thoracoscopy, Prehabilitation
- Being tested
- Educational nursing protocol, Routine hospital care
- Keywords
- Thoracoscopy, Educational nursing protocol, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational nursing protocolOther
It is a booklet given to study group ,which contains Knowledge and practice about thoracoscopy, pre - post operative care and home care instructions
Routine hospital careOther
The routine care given by physicians and nurses after thoracoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | receive educational nursing protocol Receives: Other: Educational nursing protocol; Other: Routine hospital care |
| control group | Active comparator | receive routine hospital care Receives: Other: Routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of prehabilitation on quality of life after thoracoscopic surgery
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.
Measured: after one month postoperative
Secondary outcomes (1)
effect of prehabilitation on duration of hospital stay after thoracoscopic surgery
assess length of hospital stay postoperative for both groups
Measured: immediate post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start4 Oct 2017
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThoracoscopyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Nafady Abd El Hafez, Assiut University
- Investigators
- Hussein El Khayat, Study director, faculty of medicineSahra Azer, Study director, faculty of nursingMagda Mohamed, Study director, faculty of nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915093
- Sponsor's protocol ID
- 1562017
- Acronym
- VATS
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26941973Gao 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.
PubMed 26273399
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Surgery: Effect of Designing and Implementing Educational Nursing Protocol on Patients Quality of Life
- ClinicalTrials.gov ID
- NCT03915093
- Acronym / sponsor ID
- VATS / 1562017
- Conditions
- Thoracoscopy, Prehabilitation
- Keywords
- Thoracoscopy, Educational nursing protocol, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 16 Apr 2019 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Educational nursing protocol, Other: Routine hospital carereceive educational nursing protocol |
| control group | Active comparator | Other: Routine hospital carereceive routine hospital care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who undergoing thoracoscopic surgery
- Age 18-65 year
- patients who agree to participate in the study
Key exclusion criteria (2 listed)
- converting to thoracotomy
- patients refuse to participate
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 |
|---|---|---|
| Educational nursing protocolIt is a booklet given to study group ,which contains Knowledge and practice about thoracoscopy, pre - post operative care and home care instructions | Other | study group |
| Routine hospital careThe routine care given by physicians and nurses after thoracoscopic surgery | Other | control group, study group |
Primary outcome
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.
1 secondary outcome
effect of prehabilitation on duration of hospital stay after thoracoscopic surgery
Time frame: immediate post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Background: PubMed 26941973Yeung 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.
- Background: PubMed 26273399Gao 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.
- 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.
Hussein El Khayat study director
faculty of medicine
Sahra Azer study director
faculty of nursing
Magda Mohamed study director
faculty of nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational nursing protocol and Routine hospital care in people with Thoracoscopy and Prehabilitation, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 Apr 2019. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of prehabilitation on quality of life after thoracoscopic surgery (time frame: after one month postoperative). 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 NCT03915093, which also lists 2 linked publications.
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 16 Apr 2019.