Last reviewed · How we verify

NCT03476278

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

Completed Results posted Last updated 31 May 2019
What this trial tests

trial testing Questionnaire in Outcome Assessment in 300 participants. Completed in 1 June 2011.

Timeline
1 January 2010
Primary endpoint
1 January 2011
1 June 2011

Quick facts

Lead sponsorDerince Training and Research Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment300
Start date1 January 2010
Primary completion1 January 2011
Estimated completion1 June 2011

Drugs / interventions tested

Conditions studied

Sponsor

Derince Training and Research Hospital

Who can join

Adults 18 to 75, any sex, with Outcome Assessment or Patient Satisfaction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Patient Satisfaction Primary · 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)

GroupValue95% CI
Satisfaction247
Dissatisfaction53
Overall Mood-state Primary · 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)

GroupValue95% CI
Safe137
Unsafe20
Comfortable109
Excited115
Anxious67
Patient Satisfaction According to Age Secondary · 1 day (postoperative)

patient satisfaction according to age under regional anesthesia

GroupValue95% CI
Satisfaction23
Dissatisfaction1
Satisfaction30
Dissatisfaction16
Satisfaction77
Dissatisfaction12
Satisfaction54
Dissatisfaction10
Patient Satisfaction According to Gender Secondary · 1 day

patient satisfaction according to gender under regional anesthesia

GroupValue95% CI
Satisfaction83
Dissatisfaction25
Satisfaction164
Dissatisfaction28
Patient Satisfaction According to Education Secondary · 1 day

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

GroupValue95% CI
Satisfaction112
Dissatisfaction24
Satisfaction32
Dissatisfaction8
Satisfaction59
Dissatisfaction15
Satisfaction44
Dissatisfaction6
Patient Satisfaction According to the Type of Surgery Secondary · 1 day

patient satisfaction according to the type of surgery under regional anesthesia

GroupValue95% CI
Satisfaction56
Dissatisfaction16
Satisfaction51
Dissatisfaction9
Satisfaction38
Dissatisfaction16
Satisfaction102
Dissatisfaction12
Patient Satisfaction According to Past Regional Anesthesia Experience Secondary · 1 day

patient satisfaction according to past regional anesthesia experience under regional anesthesia

GroupValue95% CI
Satisfaction115
Dissatisfaction15
Satisfaction132
Dissatisfaction38
Patient Satisfaction According to Preoperative Information Secondary · 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.)

GroupValue95% CI
Satisfaction241
Dissatisfaction44
Satisfaction6
Dissatisfaction9
Patient Satisfaction According to Intra-operative Adverse Events Secondary · 1 day

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

Hypotension
GroupValue95% CI
Satisfaction61
Dissatisfaction11
Bradycardia
GroupValue95% CI
Satisfaction22
Dissatisfaction5
Nausea-vomiting
GroupValue95% CI
Satisfaction36
Dissatisfaction12
Pain
GroupValue95% CI
Satisfaction4
Dissatisfaction9
Patient Satisfaction According to Recovery Room Adverse Events Secondary · 1 day

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

Hypotension
GroupValue95% CI
Satisfaction26
Dissatisfaction4
Bradycardia
GroupValue95% CI
Satisfaction30
Dissatisfaction6
Nausea-vomiting
GroupValue95% CI
Satisfaction14
Dissatisfaction5
Pain
GroupValue95% CI
Satisfaction28
Dissatisfaction4
Mood State According to Age Secondary · 1 day

Patients' mood state according to age

18-25
GroupValue95% CI
Safe6
Unsafe0
Comfortable8
Excited12
Anxious5
26-35
GroupValue95% CI
Safe16
Unsafe5
Comfortable11
Excited26
Anxious16
36-45
GroupValue95% CI
Safe42
Unsafe5
Comfortable32
Excited34
Anxious22
46-55
GroupValue95% CI
Safe36
Unsafe5
Comfortable24
Excited19
Anxious10
56-65
GroupValue95% CI
Safe24
Unsafe3
Comfortable24
Excited17
Anxious10
66-75
GroupValue95% CI
Safe13
Unsafe2
Comfortable10
Excited7
Anxious4
Mood State According to Gender Secondary · 1 day

Patients' mood state according to gender

Female
GroupValue95% CI
Safe45
Unsafe8
Comfortable33
Excited48
Anxious28
Male
GroupValue95% CI
Safe92
Unsafe12
Comfortable76
Excited67
Anxious39

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 day. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Regional, Questionnaire
Serious: 85/300 (28%)
Deaths: 0/300

Serious adverse events (4 terms)

ReactionSystemRegional, Questionnaire
hypotensionCardiac disorders
painSurgical and medical procedures
BradycardiaCardiac disorders
nausea-vomittingGastrointestinal disorders

Most-reported serious reactions: hypotension, pain, Bradycardia, nausea-vomitting.

Data from ClinicalTrials.gov NCT03476278 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Evaluation of factors associated with patient satisfaction and mood-state in regional anesthesia.
    Tosuner Akpinar V, Koroglu L, Gurbuz Aytuluk H. · · 2019 · cited 4× · PMID 30995331 · DOI 10.5505/agri.2018.71363

Verify or expand the search:

Other trials of Questionnaire

Trials testing the same drug.

Other recruiting trials for Outcome Assessment

Currently open trials in the same condition.

Other Derince Training and Research Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03476278.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing