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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03476278
Other study ID # U1111-1211-0907
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date June 1, 2011

Study information

Verified date February 2019
Source Derince Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date June 1, 2011
Est. primary completion date January 1, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
Postoperative questionnaire, and records of complications in the peri-operative period

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Derince Training and Research Hospital

References & Publications (5)

De Andrés J, Valía JC, Gil A, Bolinches R. Predictors of patient satisfaction with regional anesthesia. Reg Anesth. 1995 Nov-Dec;20(6):498-505. — View Citation

Donabedian A. Evaluating the quality of medical care. 1966. Milbank Q. 2005;83(4):691-729. — View Citation

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. Erratum in: Soc Sci Med 1990;30(12):following 1368. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 1 day (peri-operative)
Primary 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) 1 day
Secondary Patient Satisfaction According to Age patient satisfaction according to age under regional anesthesia 1 day (postoperative)
Secondary Patient Satisfaction According to Gender patient satisfaction according to gender under regional anesthesia 1 day
Secondary Patient Satisfaction According to Education patient satisfaction from regional anesthesia according to their highest level of education received. 1 day
Secondary Patient Satisfaction According to the Type of Surgery patient satisfaction according to the type of surgery under regional anesthesia 1 day
Secondary Patient Satisfaction According to Past Regional Anesthesia Experience patient satisfaction according to past regional anesthesia experience under regional anesthesia 1 day
Secondary 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.) 1 day
Secondary Patient Satisfaction According to Intra-operative Adverse Events patient satisfaction according to intra-operative adverse events under regional anesthesia 1 day
Secondary Patient Satisfaction According to Recovery Room Adverse Events patient satisfaction according to recovery room adverse events following surgery under regional anesthesia 1 day
Secondary Mood State According to Age Patients' mood state according to age 1 day
Secondary Mood State According to Gender Patients' mood state according to gender 1 day
Secondary Mood State According to Education Patients' mood state according to their highest degree of education received 1 day
Secondary 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.) 1 day
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