- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03476278
Evaluation of Factors Associated With Patient Satisfaction and Mood-State in Regional Anesthesia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients who underwent gynecological and obstetrical, urological, orthopedic and general surgical procedures under general anesthesia
Exclusion Criteria:
- clinically significant psychiatrically ill illiterate patients who received general anesthesia patients that have speech, hearing, or understanding problems
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
regional, questionnaire
patients who underwent surgery under regional anesthesia.
|
Postoperative questionnaire, and records of complications in the peri-operative period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 day (peri-operative)
|
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)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction According to Age
Time Frame: 1 day (postoperative)
|
patient satisfaction according to age under regional anesthesia
|
1 day (postoperative)
|
Patient Satisfaction According to Gender
Time Frame: 1 day
|
patient satisfaction according to gender under regional anesthesia
|
1 day
|
Patient Satisfaction According to Education
Time Frame: 1 day
|
patient satisfaction from regional anesthesia according to their highest level of education received.
|
1 day
|
Patient Satisfaction According to the Type of Surgery
Time Frame: 1 day
|
patient satisfaction according to the type of surgery under regional anesthesia
|
1 day
|
Patient Satisfaction According to Past Regional Anesthesia Experience
Time Frame: 1 day
|
patient satisfaction according to past regional anesthesia experience under regional anesthesia
|
1 day
|
Patient Satisfaction According to Preoperative Information
Time Frame: 1 day
|
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.)
|
1 day
|
Patient Satisfaction According to Intra-operative Adverse Events
Time Frame: 1 day
|
patient satisfaction according to intra-operative adverse events under regional anesthesia
|
1 day
|
Patient Satisfaction According to Recovery Room Adverse Events
Time Frame: 1 day
|
patient satisfaction according to recovery room adverse events following surgery under regional anesthesia
|
1 day
|
Mood State According to Age
Time Frame: 1 day
|
Patients' mood state according to age
|
1 day
|
Mood State According to Gender
Time Frame: 1 day
|
Patients' mood state according to gender
|
1 day
|
Mood State According to Education
Time Frame: 1 day
|
Patients' mood state according to their highest degree of education received
|
1 day
|
Mood State According to Preoperative Information
Time Frame: 1 day
|
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.)
|
1 day
|
Collaborators and Investigators
Investigators
- Study Director: Vildan Akpinar, MD, Izmir Bozyaka Training and Research Hospital
Publications and helpful links
General 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.
- Donabedian 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.
- Lohr 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.
- Myles 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.
- Hall 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. Erratum In: Soc Sci Med 1990;30(12):following 1368.
- Tosuner 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- U1111-1211-0907
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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