Outcome AssessmentNCT03476278
Evaluation of Factors Associated With Patient Satisfaction and Mood-State in Regional Anesthesia
An observational study of Outcome Assessment and Patient Satisfaction, run by Derince Training and Research Hospital.
Trial summary
Patient satisfaction is an important subjective measure of healthcare quality which contributes to evaluation of the structure, process and outcome of services. The key factor in patient satisfaction is adequate perioperative information of the patient and communication between healthcare providers and patient or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Outcome Assessment, Patient Satisfaction
- What is being tested?
- Questionnaire
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Jun 2011
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent gynecological and obstetrical, urological, orthopedic and general surgical procedures under general anesthesia
Who may be able to join
- patients who underwent gynecological and obstetrical, urological, orthopedic and general surgical procedures under general anesthesia
Who cannot join
- clinically significant psychiatrically ill illiterate patients who received general anesthesia patients that have speech, hearing, or understanding problems
About this study
Patient satisfaction is an important subjective measure of healthcare quality which contributes to evaluation of the structure, process and outcome of services. The key factor in patient satisfaction is adequate perioperative information of the patient and communication between healthcare providers and patient or patient's kin.
There are few studies in anesthesia that have assessed patient satisfaction and mood-state during regional anesthesia.
The investigators aimed to evaluate factors associated with patient satisfaction from regional anesthesia procedure and mood-state of patients who underwent surgery under regional anesthesia.
Read the detailed description
Patient satisfaction is an important subjective measure of healthcare quality which contributes to evaluation of the structure, process and outcome of services. Many factors contribute to patient satisfaction, including institutional structure, interpersonal relationships, and a patient' expectations. Age, gender, social insurance, educational and social statue also play role in patient satisfaction. The key factor in patient satisfaction is adequate perioperative information of the patient and communication between healthcare providers and patient or patient's kin.
The success of regional anesthesia is influenced by several factors. Most patients expect uneventful perioperative process. Nevertheless, recovery from surgery and anesthesia is sometimes complicated by major and minor complaints including pain, nausea, vomiting and other. Although there is no scientific or clinical evidence that regional anesthesia is superior to general anesthesia, regional anesthesia has some advantages like keeping consciousness of the patient during surgery, continuation of spontaneous breathing, avoiding the loss of protective reflexes, allowing early mobilization in the postoperative period and shortening the length of hospital stay. However, the major contraindication for regional anesthesia is the patient's unwillingness.
There are few studies in anesthesia that have assessed patient satisfaction and mood-state during regional anesthesia.
The investigators aimed to evaluate factors associated with patient satisfaction from regional anesthesia procedure and mood-state of patients who underwent surgery under regional anesthesia.
- Conditions
- Outcome Assessment, Patient Satisfaction
- Being tested
- Questionnaire
- Keywords
- Outcome Assessment (Health Care), Patient Satisfaction, Perioperative Period, Regional Anesthesia, Surveys and Questionnaires
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Postoperative questionnaire, and records of complications in the peri-operative period
| Study group | Role | What they receive |
|---|---|---|
| regional, questionnaire | patients who underwent surgery under regional anesthesia. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Patient Satisfaction
satisfaction of patients during regional anesthesia (patients will be handed a questionnaire about their satisfaction in recovery room or in ward. They will be able to mark only one option: satisfaction, dissatisfaction)
Measured: 1 day (peri-operative)
Overall Mood-state
mood-state of patients during regional anesthesia (patients will be handed a questionnaire about their mood-state in recovery room or in ward. They will be able to mark more than one option about their mood-state: safe, unsafe, comfortable, exited, anxious)
Measured: 1 day
Secondary outcomes (12)
Patient Satisfaction According to Age
patient satisfaction according to age under regional anesthesia
Measured: 1 day (postoperative)
Patient Satisfaction According to Gender
patient satisfaction according to gender under regional anesthesia
Measured: 1 day
Patient Satisfaction According to Education
patient satisfaction from regional anesthesia according to their highest level of education received.
Measured: 1 day
Patient Satisfaction According to the Type of Surgery
patient satisfaction according to the type of surgery under regional anesthesia
Measured: 1 day
Patient Satisfaction According to Past Regional Anesthesia Experience
patient satisfaction according to past regional anesthesia experience under regional anesthesia
Measured: 1 day
Patient Satisfaction According to Preoperative Information
Patients who were given additional preoperative information about regional anesthesia and the things they would encounter during regional anesthesia (ie: they will feel the touches but pain is not expected to be felt, they can feel nausea because of the side-effect of the regional block, what will be done if the regional blocks are unsuccessful and they feel pain,..etc.)
Measured: 1 day
Patient Satisfaction According to Intra-operative Adverse Events
patient satisfaction according to intra-operative adverse events under regional anesthesia
Measured: 1 day
Patient Satisfaction According to Recovery Room Adverse Events
patient satisfaction according to recovery room adverse events following surgery under regional anesthesia
Measured: 1 day
Mood State According to Age
Patients' mood state according to age
Measured: 1 day
Mood State According to Gender
Patients' mood state according to gender
Measured: 1 day
Mood State According to Education
Patients' mood state according to their highest degree of education received
Measured: 1 day
Mood State According to Preoperative Information
Patients who were given additional preoperative information about regional anesthesia and the things they would encounter during regional anesthesia (ie: they will feel the touches but pain is not expected to be felt, they can feel nausea because of the side-effect of the regional block, what will be done if the regional blocks are unsuccessful and they feel pain,..etc.)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jan 2010
- Primary completion1 Jan 2011
- Study completion1 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Outcome AssessmentStudies 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
- 300 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande G. Aytuluk, Derince Training and Research Hospital
- Investigators
- Vildan Akpinar, MD, Study director, Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476278
- Sponsor's protocol ID
- U1111-1211-0907
- Status last verified
- Feb 2019
- First submitted
- 17 Mar 2018
- Last updated
- 31 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators do not prefer to share the study plan and records.
Publications
De Andres J, Valia JC, Gil A, Bolinches R. Predictors of patient satisfaction with regional anesthesia. Reg Anesth. 1995 Nov-Dec;20(6):498-505.
PubMed 8608068Donabedian A. Evaluating the quality of medical care. 1966. Milbank Q. 2005;83(4):691-729. doi: 10.1111/j.1468-0009.2005.00397.x. No abstract available.
PubMed 16279964Lohr KN, Donaldson MS, Harris-Wehling J. Medicare: a strategy for quality assurance, V: Quality of care in a changing health care environment. QRB Qual Rev Bull. 1992 Apr;18(4):120-6. doi: 10.1016/s0097-5990(16)30518-8.
PubMed 1630793Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.
PubMed 10740539Hall JA, Dornan MC. Patient sociodemographic characteristics as predictors of satisfaction with medical care: a meta-analysis. Soc Sci Med. 1990;30(7):811-8. doi: 10.1016/0277-9536(90)90205-7.
PubMed 2138357Tosuner Akpinar V, Koroglu L, Gurbuz Aytuluk H. Evaluation of factors associated with patient satisfaction and mood-state in regional anesthesia. Agri. 2019 Apr;31(2):57-62. doi: 10.5505/agri.2018.71363.
PubMed 30995331
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Factors Associated With Patient Satisfaction and Mood-State in Regional Anesthesia
- ClinicalTrials.gov ID
- NCT03476278
- Acronym / sponsor ID
- U1111-1211-0907
- Conditions
- Outcome Assessment, Patient Satisfaction
- Keywords
- Outcome Assessment (Health Care), Patient Satisfaction, Perioperative Period, Regional Anesthesia, Surveys and Questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2011 (actual)
- Study completion
- 1 Jun 2011 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient satisfaction is an important subjective measure of healthcare quality which contributes to evaluation of the structure, process and outcome of services. The key factor in patient satisfaction is adequate perioperative information of the patient and communication between healthcare providers and patient or patient's kin.
There are few studies in anesthesia that have assessed patient satisfaction and mood-state during regional anesthesia.
The investigators aimed to evaluate factors associated with patient satisfaction from regional anesthesia procedure and mood-state of patients who underwent surgery under regional anesthesia.
Detailed description
Patient satisfaction is an important subjective measure of healthcare quality which contributes to evaluation of the structure, process and outcome of services. Many factors contribute to patient satisfaction, including institutional structure, interpersonal relationships, and a patient' expectations. Age, gender, social insurance, educational and social statue also play role in patient satisfaction. The key factor in patient satisfaction is adequate perioperative information of the patient and communication between healthcare providers and patient or patient's kin.
The success of regional anesthesia is influenced by several factors. Most patients expect uneventful perioperative process. Nevertheless, recovery from surgery and anesthesia is sometimes complicated by major and minor complaints including pain, nausea, vomiting and other. Although there is no scientific or clinical evidence that regional anesthesia is superior to general anesthesia, regional anesthesia has some advantages like keeping consciousness of the patient during surgery, continuation of spontaneous breathing, avoiding the loss of protective reflexes, allowing early mobilization in the postoperative period and shortening the length of hospital stay. However, the major contraindication for regional anesthesia is the patient's unwillingness.
There are few studies in anesthesia that have assessed patient satisfaction and mood-state during regional anesthesia.
The investigators aimed to evaluate factors associated with patient satisfaction from regional anesthesia procedure and mood-state of patients who underwent surgery under regional anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| regional, questionnaire | – | Other: Questionnairepatients who underwent surgery under regional anesthesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent gynecological and obstetrical, urological, orthopedic and general surgical procedures under general anesthesia
Key inclusion criteria (1 listed)
- patients who underwent gynecological and obstetrical, urological, orthopedic and general surgical procedures under general anesthesia
Key exclusion criteria (1 listed)
- clinically significant psychiatrically ill illiterate patients who received general anesthesia patients that have speech, hearing, or understanding problems
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 |
|---|---|---|
| QuestionnairePostoperative questionnaire, and records of complications in the peri-operative period | Other | regional, questionnaire |
Primary outcome
Overall Patient Satisfaction
Time frame: 1 day (peri-operative)
satisfaction of patients during regional anesthesia (patients will be handed a questionnaire about their satisfaction in recovery room or in ward. They will be able to mark only one option: satisfaction, dissatisfaction)
Overall Mood-state
Time frame: 1 day
mood-state of patients during regional anesthesia (patients will be handed a questionnaire about their mood-state in recovery room or in ward. They will be able to mark more than one option about their mood-state: safe, unsafe, comfortable, exited, anxious)
12 secondary outcomes
Patient Satisfaction According to Age
Time frame: 1 day (postoperative)
Patient Satisfaction According to Gender
Time frame: 1 day
Patient Satisfaction According to Education
Time frame: 1 day
Patient Satisfaction According to the Type of Surgery
Time frame: 1 day
Patient Satisfaction According to Past Regional Anesthesia Experience
Time frame: 1 day
Patient Satisfaction According to Preoperative Information
Time frame: 1 day
Patient Satisfaction According to Intra-operative Adverse Events
Time frame: 1 day
Patient Satisfaction According to Recovery Room Adverse Events
Time frame: 1 day
Mood State According to Age
Time frame: 1 day
Mood State According to Gender
Time frame: 1 day
Mood State According to Education
Time frame: 1 day
Mood State According to Preoperative Information
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 8608068De Andres J, Valia JC, Gil A, Bolinches R. Predictors of patient satisfaction with regional anesthesia. Reg Anesth. 1995 Nov-Dec;20(6):498-505.
- Results publication: PubMed 16279964Donabedian A. Evaluating the quality of medical care. 1966. Milbank Q. 2005;83(4):691-729. doi: 10.1111/j.1468-0009.2005.00397.x. No abstract available.
- Results publication: PubMed 1630793Lohr KN, Donaldson MS, Harris-Wehling J. Medicare: a strategy for quality assurance, V: Quality of care in a changing health care environment. QRB Qual Rev Bull. 1992 Apr;18(4):120-6. doi: 10.1016/s0097-5990(16)30518-8.
- Results publication: PubMed 10740539Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.
- Results publication: PubMed 2138357Hall JA, Dornan MC. Patient sociodemographic characteristics as predictors of satisfaction with medical care: a meta-analysis. Soc Sci Med. 1990;30(7):811-8. doi: 10.1016/0277-9536(90)90205-7.
- Derived from this study: PubMed 30995331Tosuner Akpinar V, Koroglu L, Gurbuz Aytuluk H. Evaluation of factors associated with patient satisfaction and mood-state in regional anesthesia. Agri. 2019 Apr;31(2):57-62. doi: 10.5505/agri.2018.71363.
- Individual participant dataSharing planned: Undecided. The investigators do not prefer to share the study plan and records.
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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.
Vildan Akpinar, MD study director
Izmir Bozyaka Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome Assessment and Patient Satisfaction, run by Derince Training and Research Hospital.
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: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Patient Satisfaction (time frame: 1 day (peri-operative)). The study lists 2 primary outcomes in all. 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 NCT03476278, which also lists 6 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 31 May 2019.