ClinicalTrials.gg
CompletedNCT03476278Updated May 31, 2019Results posted

Evaluation of Factors Associated With Patient Satisfaction and Mood-State in Regional Anesthesia

An observational study in Outcome Assessment and Patient Satisfaction, sponsored by Derince Training and Research Hospital. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-31.

Sponsored by Derince Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Outcome Assessment
  • Patient Satisfaction

Browse trials for

Keywords

  • Outcome Assessment (Health Care)
  • Patient Satisfaction
  • Perioperative Period
  • Regional Anesthesia
  • Surveys and Questionnaires
03

In context

Patient Satisfaction

877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.

This study's enrollment of 300 is above the median of 149 across 225 observational studies indexed under Patient Satisfaction.

Browse Patient Satisfaction studies →

Lead sponsor

Derince Training and Research Hospital is the lead sponsor of 39 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients who underwent gynecological and obstetrical, urological, orthopedic and general surgical procedures under general anesthesia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients who underwent gynecological and obstetrical, urological, orthopedic and general surgical procedures under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • psychiatrically ill illiterate patients who received general anesthesia patients that have speech, hearing, or understanding problems
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • regional, questionnaire

    patients who underwent surgery under regional anesthesia.

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 day (peri-operative)

  2. 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)

    Time frame: 1 day

Secondary outcomes

  1. Patient Satisfaction According to Age

    patient satisfaction according to age under regional anesthesia

    Time frame: 1 day (postoperative)

  2. Patient Satisfaction According to Gender

    patient satisfaction according to gender under regional anesthesia

    Time frame: 1 day

  3. Patient Satisfaction According to Education

    patient satisfaction from regional anesthesia according to their highest level of education received.

    Time frame: 1 day

  4. Patient Satisfaction According to the Type of Surgery

    patient satisfaction according to the type of surgery under regional anesthesia

    Time frame: 1 day

  5. Patient Satisfaction According to Past Regional Anesthesia Experience

    patient satisfaction according to past regional anesthesia experience under regional anesthesia

    Time frame: 1 day

  6. 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.)

    Time frame: 1 day

  7. Patient Satisfaction According to Intra-operative Adverse Events

    patient satisfaction according to intra-operative adverse events under regional anesthesia

    Time frame: 1 day

  8. Patient Satisfaction According to Recovery Room Adverse Events

    patient satisfaction according to recovery room adverse events following surgery under regional anesthesia

    Time frame: 1 day

  9. Mood State According to Age

    Patients' mood state according to age

    Time frame: 1 day

  10. Mood State According to Gender

    Patients' mood state according to gender

    Time frame: 1 day

  11. Mood State According to Education

    Patients' mood state according to their highest degree of education received

    Time frame: 1 day

  12. 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.)

    Time frame: 1 day

07

Results

Posted May 31, 2019

Participant flow

Participant flow — Overall Study
MilestoneRegional
Started300
Completed300
Not completed0

Outcome measures

PrimaryOverall 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)

Time frame:
1 day (peri-operative)
Reported as:
Count of participants · Participants
Overall Patient Satisfaction
ParticipantsSatisfactionDissatisfaction
Overall Patient Satisfaction24753
PrimaryOverall 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)

Time frame:
1 day
Reported as:
Count of participants · Participants
Overall Mood-state
ParticipantsSafeUnsafeComfortableExcitedAnxious
Overall Mood-state1372010911567
SecondaryPatient Satisfaction According to Age

patient satisfaction according to age under regional anesthesia

Time frame:
1 day (postoperative)
Reported as:
Count of participants · Participants
Patient Satisfaction According to Age
ParticipantsSatisfactionDissatisfaction
18-25231
26-353016
36-457712
46-555410
56-654110
66-75224
SecondaryPatient Satisfaction According to Gender

patient satisfaction according to gender under regional anesthesia

Time frame:
1 day
Reported as:
Count of participants · Participants
Patient Satisfaction According to Gender
ParticipantsSatisfactionDissatisfaction
Female8325
Male16428
SecondaryPatient Satisfaction According to Education

patient satisfaction from regional anesthesia according to their highest level of education received.

Time frame:
1 day
Reported as:
Count of participants · Participants
Patient Satisfaction According to Education
ParticipantsSatisfactionDissatisfaction
Primary school11224
Junior high school328
High school5915
University446
SecondaryPatient Satisfaction According to the Type of Surgery

patient satisfaction according to the type of surgery under regional anesthesia

Time frame:
1 day
Reported as:
Count of participants · Participants
Patient Satisfaction According to the Type of Surgery
ParticipantsSatisfactionDissatisfaction
General5616
Orthopedic519
Gynecology & obstetric3816
Urology10212
SecondaryPatient Satisfaction According to Past Regional Anesthesia Experience

patient satisfaction according to past regional anesthesia experience under regional anesthesia

Time frame:
1 day
Reported as:
Count of participants · Participants
Patient Satisfaction According to Past Regional Anesthesia Experience
ParticipantsSatisfactionDissatisfaction
yes11515
no13238
SecondaryPatient 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.)

Time frame:
1 day
Reported as:
Count of participants · Participants
Patient Satisfaction According to Preoperative Information
ParticipantsSatisfactionDissatisfaction
yes24144
no69
SecondaryPatient Satisfaction According to Intra-operative Adverse Events

patient satisfaction according to intra-operative adverse events under regional anesthesia

Time frame:
1 day
Reported as:
Number · number of experienced adverse events
Patient Satisfaction According to Intra-operative Adverse Events
number of experienced adverse eventsSatisfactionDissatisfaction
Hypotension6111
Bradycardia225
Nausea-vomiting3612
Pain49
SecondaryPatient Satisfaction According to Recovery Room Adverse Events

patient satisfaction according to recovery room adverse events following surgery under regional anesthesia

Time frame:
1 day
Reported as:
Count of units · adverse events
Patient Satisfaction According to Recovery Room Adverse Events
adverse eventsSatisfactionDissatisfaction
Hypotension264
Bradycardia306
Nausea-vomiting145
Pain284
SecondaryMood State According to Age

Patients' mood state according to age

Time frame:
1 day
Reported as:
Count of participants · Participants
Mood State According to Age
ParticipantsSafeUnsafeComfortableExcitedAnxious
18-25608125
26-35165112616
36-45425323422
46-55365241910
56-65243241710
66-751321074
SecondaryMood State According to Gender

Patients' mood state according to gender

Time frame:
1 day
Reported as:
Count of participants · Participants
Mood State According to Gender
ParticipantsSafeUnsafeComfortableExcitedAnxious
Female458334828
Male9212766739
SecondaryMood State According to Education

Patients' mood state according to their highest degree of education received

Time frame:
1 day
Reported as:
Count of participants · Participants
Mood State According to Education
ParticipantsSafeUnsafeComfortableExcitedAnxious
Primary school6410574732
Junior high school161151511
High school317213714
University262161610
SecondaryMood 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.)

Time frame:
1 day
Reported as:
Count of participants · Participants
Mood State According to Preoperative Information
ParticipantsSafeUnsafeComfortableExcitedAnxious
yes1341710611060
no33357

Adverse events

Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Regional, Questionnaire0/300 (0%)85/300 (28.3%)0/300 (0%)
Most frequent serious events
Most frequent serious events
EventRegional, Questionnaire
hypotensionCardiac disorders83/300
painSurgical and medical procedures36/300
BradycardiaCardiac disorders32/300
nausea-vomittingGastrointestinal disorders24/300

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Regional
<=18 years0
Between 18 and 65 years274
>=65 years26
Sex: Female, Male
Sex: Female, Male(Participants)Regional
Female108
Male192
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Regional
08

Study locations

No study locations are listed for this record.

09

References and documents

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 8608068 ↗
  • 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. PubMed 16279964 ↗
  • 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. PubMed 1630793 ↗
  • 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. PubMed 10740539 ↗
  • 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. PubMed 2138357 ↗
  • 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. PubMed 30995331 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — The investigators do not prefer to share the study plan and records.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2010 to primary completion in Jan 2011, 12 months.

Results were first posted in May 2019, 8 years 4 months after primary completion.

Of 105 non-industry observational studies under Patient Satisfaction, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 45. This study's 12 months is below that.

Counting every sponsor, half of 111 studies reached it within 20 months; a quarter within 7 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2018
First posted
Mar 26, 2018
StartActual
Jan 1, 2010
Primary completionActual
Jan 1, 2011
CompletionActual
Jun 1, 2011
Results first posted
May 31, 2019
Last update
May 31, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03476278
Lead sponsor
Derince Training and Research Hospital
Responsible party
Hande G. Aytuluk (Principal Investigator, Derince Training and Research Hospital) — Principal investigator
First posted
Mar 26, 2018
Start date
Jan 1, 2010
Primary completion
Jan 1, 2011
Completion
Jun 1, 2011
Results posted
May 31, 2019
Last update
May 31, 2019

Study contacts

Vildan Akpinar, MD
study director · Izmir Bozyaka Training and Research Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion