Patient Relations, NurseAnesthesiaNCT03037996
To Develop a Validated Program and Use it to Evaluate Patients Post-operatively
An observational study of Patient Relations, Nurse and Post-operative Patients, run by Siriraj Hospital at 2 sites in Thailand.
Trial summary
Annually, the Department of Anesthesiology, Siriraj hospital has responsibilities to take care of more than 50,000 patients peri-operatively. According to Maslow's hierarchy of needs; human's pleasure is classified as physiological, safety, belonging, esteem and self-actualization. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patient Relations, Nurse, Post-operative Patients
- What is being tested?
- patients' response
- How many people
- 450 participants
- Where
- 2 sitesThailand
- Study dates
- 23 Jan 2017to 31 Dec 2017
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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
Study population: A developed and validated questionnaire will be studied in 450 patients as target group (4 months). Post-operatively, a nurse anesthetist visits a patient to explain the details of the study and ask for consent. Afterwards, a participant responses to a questionnaire privately (10 minutes). Co-investigators collect data in a computer file. A statistician who not involved in the study analyzes the data.
Who may be able to join
- Volunteered, literate and communicable, well-conscious, in-patients ASA I-III, aged 18-65 years who underwent elective surgery.
Who cannot join
- Patients with severe diseases such as congestive heart failure, end-stage renal disease, etc. Patients refuse to join the study.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
Official title: The Develop a Validated Si-2-AQ and Use it to Evaluate Patients Postoperatively
Annually, the Department of Anesthesiology, Siriraj hospital has responsibilities to take care of more than 50,000 patients peri-operatively. According to Maslow's hierarchy of needs; human's pleasure is classified as physiological, safety, belonging, esteem and self-actualization. Since defining and measuring quality of healthcare service is an inevitable challenge for all institutes in medical fields, a questionnaire is developed to assess the quality of all services. The Siriraj Anesthesia Quality Assessment Questionnaire (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises Accessibility and convenience, Communication and Information, Process of care, Technical Quality, Psychological support, Physical support and Royalty.
Read the detailed description
Anesthesia service is the medical specialty that focuses on peri-operative medicine and the administration of anesthetics. It expresses traditionally as the conditions of no pain perception during surgical procedure. This includes three broad categories: 1) General Anesthesia is a medically induced state of unconsciousness with loss of protective reflexes; 2) Sedation is a state of irritability or agitation reduction to facilitate a medical or diagnostic procedure; and 3) Regional Anesthesia is a technique to abolish either or both motor and sensory sensitivity in a specific part of the body.
Siriraj Hospital, Mahidol University, Bangkok is a tertiary, general hospital with more than 2,200 beds. Annually, the Department of Anesthesiology has responsibilities to take care of more than 50,000 patients peri-operatively. Currently, it plays a part in many surgical departments: Traumatic surgery (TRAU); Orthopedics surgery (ORT); Eye surgery (EYE); Ear, Nose and Throat surgery (ENT); Plastics surgery (PLA); Cardio-thoracic surgery (CVT); Neurosurgery (NEU); General surgery (GEN), Urological surgery (URO); Head and Neck surgery (H\&N); Pediatric surgery (PED); Obstetrics surgery (OBG); Gynecological surgery (GYN); Electro-convulsive therapy (PSY); Radiological services (RAD); Endoscopic center (SCOP); Intensive Care Unit (ICU); Acute Pain service (APS); Pain Clinic (PC); and Pre-Anesthesia Assessment Center (SiPAC).
According to Maslow's hierarchy of needs; human's pleasure is classified as physiological, safety, belonging, esteem and self-actualization. Likewise, patients' satisfaction seems to cover all these aspects; since participants crave for an excellent healthcare services. As a result, their contentment become a crucial factor to determine the quality of care particularly in Anesthesia procedure. This includes many processes in peri-Anesthesia management such as patient safety in operating theater, pain controlling and mutually convenient inter-relationship, etc. To solve these procedural running by means of patients' desires, a quality survey seems to be a promising tool that right on the target.
Since defining and measuring quality of healthcare service is an inevitable challenge for all institutes in medical fields, many organizations try to work out intensively. Currently, there are many leading quality assessment tools in healthcare services, namely Hospital Consumer Assessment of Healthcare Providers and System (HCAHPS), Patient Satisfaction Questionnaire (PSQ), Service Quality Questionnaire (SERVQUAL), Quality of Recover after anesthesia 40 (QoR-40), Post-operative Quality of Recovery Questionnaire and Developing and Testing Questionnaire. These tests have been already verified for its validity and reliability.
HCAHPS a 33-item survey in three dimensions, comprises nurse and doctor communication, medical communication, responsiveness of hospital staff, pain management, discharge information, care transition 17 items; cleanliness and quietness of hospital environment 2 items; as well as overall rating of hospital and willingness to recommend hospital 2 items.
PSQ an 18-item questionnaire in seven dimensions, consists of general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor as well as accessibility and convenience.
SERVQUAL a questionnaire related to hospital services in five dimensions, is composed of tangibles, reliability, responsiveness, assurance and empathy.
QoR-40 a 40-item questionnaire concerning good quality recovery after anesthesia and surgery, includes emotional states, physical and physiological support, physical independence and pain management.
Based upon the previously mentioned; investigators, therefore, would like to develop a questionnaire to assess the quality of our services. The Siriraj Anesthesia Quality Assessment Questionnaire (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises Accessibility and convenience (5 items), Communication and Information (10 items), Process of care (8 items), Technical Quality (9 items) Psychological support (4 items) Physical support (2 items) and Royalty (2 items).
- Conditions
- Patient Relations, Nurse, Post-operative Patients
- Being tested
- patients' response
- Keywords
- anesthesia, satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients' responseOther
patients' satisfaction to anesthesia services
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' satisfaction
questionnaires
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start23 Jan 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Relations, NurseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudta Parakkamodom, Siriraj Hospital
- Investigators
- Chairal Shayakul, M.D., Study chair, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037996
- Sponsor's protocol ID
- COA no. Si 790/2016
- Acronym
- Anesthesia
- Status last verified
- Oct 2017
- First submitted
- 23 Jan 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Develop a Validated Si-2-AQ and Use it to Evaluate Patients Postoperatively
- ClinicalTrials.gov ID
- NCT03037996
- Acronym / sponsor ID
- Anesthesia / COA no. Si 790/2016
- Conditions
- Patient Relations, Nurse, Post-operative Patients
- Keywords
- anesthesia, satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- 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.
Annually, the Department of Anesthesiology, Siriraj hospital has responsibilities to take care of more than 50,000 patients peri-operatively. According to Maslow's hierarchy of needs; human's pleasure is classified as physiological, safety, belonging, esteem and self-actualization. Since defining and measuring quality of healthcare service is an inevitable challenge for all institutes in medical fields, a questionnaire is developed to assess the quality of all services. The Siriraj Anesthesia Quality Assessment Questionnaire (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises Accessibility and convenience, Communication and Information, Process of care, Technical Quality, Psychological support, Physical support and Royalty.
Detailed description
Anesthesia service is the medical specialty that focuses on peri-operative medicine and the administration of anesthetics. It expresses traditionally as the conditions of no pain perception during surgical procedure. This includes three broad categories: 1) General Anesthesia is a medically induced state of unconsciousness with loss of protective reflexes; 2) Sedation is a state of irritability or agitation reduction to facilitate a medical or diagnostic procedure; and 3) Regional Anesthesia is a technique to abolish either or both motor and sensory sensitivity in a specific part of the body.
Siriraj Hospital, Mahidol University, Bangkok is a tertiary, general hospital with more than 2,200 beds. Annually, the Department of Anesthesiology has responsibilities to take care of more than 50,000 patients peri-operatively. Currently, it plays a part in many surgical departments: Traumatic surgery (TRAU); Orthopedics surgery (ORT); Eye surgery (EYE); Ear, Nose and Throat surgery (ENT); Plastics surgery (PLA); Cardio-thoracic surgery (CVT); Neurosurgery (NEU); General surgery (GEN), Urological surgery (URO); Head and Neck surgery (H\&N); Pediatric surgery (PED); Obstetrics surgery (OBG); Gynecological surgery (GYN); Electro-convulsive therapy (PSY); Radiological services (RAD); Endoscopic center (SCOP); Intensive Care Unit (ICU); Acute Pain service (APS); Pain Clinic (PC); and Pre-Anesthesia Assessment Center (SiPAC).
According to Maslow's hierarchy of needs; human's pleasure is classified as physiological, safety, belonging, esteem and self-actualization. Likewise, patients' satisfaction seems to cover all these aspects; since participants crave for an excellent healthcare services. As a result, their contentment become a crucial factor to determine the quality of care particularly in Anesthesia procedure. This includes many processes in peri-Anesthesia management such as patient safety in operating theater, pain controlling and mutually convenient inter-relationship, etc. To solve these procedural running by means of patients' desires, a quality survey seems to be a promising tool that right on the target.
Since defining and measuring quality of healthcare service is an inevitable challenge for all institutes in medical fields, many organizations try to work out intensively. Currently, there are many leading quality assessment tools in healthcare services, namely Hospital Consumer Assessment of Healthcare Providers and System (HCAHPS), Patient Satisfaction Questionnaire (PSQ), Service Quality Questionnaire (SERVQUAL), Quality of Recover after anesthesia 40 (QoR-40), Post-operative Quality of Recovery Questionnaire and Developing and Testing Questionnaire. These tests have been already verified for its validity and reliability.
HCAHPS a 33-item survey in three dimensions, comprises nurse and doctor communication, medical communication, responsiveness of hospital staff, pain management, discharge information, care transition 17 items; cleanliness and quietness of hospital environment 2 items; as well as overall rating of hospital and willingness to recommend hospital 2 items.
PSQ an 18-item questionnaire in seven dimensions, consists of general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor as well as accessibility and convenience.
SERVQUAL a questionnaire related to hospital services in five dimensions, is composed of tangibles, reliability, responsiveness, assurance and empathy.
QoR-40 a 40-item questionnaire concerning good quality recovery after anesthesia and surgery, includes emotional states, physical and physiological support, physical independence and pain management.
Based upon the previously mentioned; investigators, therefore, would like to develop a questionnaire to assess the quality of our services. The Siriraj Anesthesia Quality Assessment Questionnaire (Si-2-AQ), a simply 40-item tool in seven dimensions, comprises Accessibility and convenience (5 items), Communication and Information (10 items), Process of care (8 items), Technical Quality (9 items) Psychological support (4 items) Physical support (2 items) and Royalty (2 items).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A developed and validated questionnaire will be studied in 450 patients as target group (4 months). Post-operatively, a nurse anesthetist visits a patient to explain the details of the study and ask for consent. Afterwards, a participant responses to a questionnaire privately (10 minutes). Co-investigators collect data in a computer file. A statistician who not involved in the study analyzes the data.
Key inclusion criteria (1 listed)
- Volunteered, literate and communicable, well-conscious, in-patients ASA I-III, aged 18-65 years who underwent elective surgery.
Key exclusion criteria (1 listed)
- Patients with severe diseases such as congestive heart failure, end-stage renal disease, etc. Patients refuse to join the study.
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 |
|---|---|---|
| patients' responsepatients' satisfaction to anesthesia services | Other | – |
Primary outcome
Patients' satisfaction
Time frame: 4 months
questionnaires
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- 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.
Chairal Shayakul, M.D. study chair
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Relations, Nurse and Post-operative Patients, run by Siriraj Hospital at 2 sites in Thailand.
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 1 inclusion and 1 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 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
Patients' satisfaction (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2017.