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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in Thailand

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).

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.

  1. 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.

  1. First posted31 Jan 2017 (estimated)
  2. Study start23 Jan 2017
  3. Primary completion31 Dec 2017 (estimated)
  4. Study completion31 Dec 2017 (estimated)

Resources

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
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

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.

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