Trial Outcomes & Findings for Evaluation of Factors Associated With Patient Satisfaction and Mood-State in Regional Anesthesia (NCT NCT03476278)

NCT ID: NCT03476278

Last Updated: 2019-05-31

Results Overview

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)

• Recruitment status: COMPLETED
• Target enrollment: 300 participants
• Primary outcome timeframe: 1 day (peri-operative)
• Results posted on: 2019-05-31

Participant Flow

Participant milestones

Measure	Regional patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period
Overall Study STARTED	300
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Regional n=300 Participants patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period
Age, Categorical <=18 years	0 Participants n=300 Participants
Age, Categorical Between 18 and 65 years	274 Participants n=300 Participants
Age, Categorical >=65 years	26 Participants n=300 Participants
Sex: Female, Male Female	108 Participants n=300 Participants
Sex: Female, Male Male	192 Participants n=300 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Satisfaction n=300 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=300 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable Patients who feel comfortable under regional anesthesia	Excited Patients who feel excited under regional anesthesia	Anxious Patients who feel anxious under regional anesthesia
Overall Patient Satisfaction	247 Participants	53 Participants	—	—	—

PRIMARY outcome

Timeframe: 1 day

Population: Patients were able to mark more than one option in the part of the questionnaire about mood-state: safe, unsafe, comfortable, exited, anxious. If patient was heavily sedated and too confused to participate, the questionnaire was handed at the ward after recovery.

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)

Outcome measures

Measure	Satisfaction n=300 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=300 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable n=300 Participants Patients who feel comfortable under regional anesthesia	Excited n=300 Participants Patients who feel excited under regional anesthesia	Anxious n=300 Participants Patients who feel anxious under regional anesthesia
Overall Mood-state	137 Participants	20 Participants	109 Participants	115 Participants	67 Participants

SECONDARY outcome

Timeframe: 1 day (postoperative)

patient satisfaction according to age under regional anesthesia

Outcome measures

Measure	Satisfaction n=247 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=53 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable Patients who feel comfortable under regional anesthesia	Excited Patients who feel excited under regional anesthesia	Anxious Patients who feel anxious under regional anesthesia
Patient Satisfaction According to Age 18-25	23 Participants	1 Participants	—	—	—
Patient Satisfaction According to Age 26-35	30 Participants	16 Participants	—	—	—
Patient Satisfaction According to Age 36-45	77 Participants	12 Participants	—	—	—
Patient Satisfaction According to Age 46-55	54 Participants	10 Participants	—	—	—
Patient Satisfaction According to Age 56-65	41 Participants	10 Participants	—	—	—
Patient Satisfaction According to Age 66-75	22 Participants	4 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 day

patient satisfaction according to gender under regional anesthesia

Outcome measures

Measure	Satisfaction n=247 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=53 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable Patients who feel comfortable under regional anesthesia	Excited Patients who feel excited under regional anesthesia	Anxious Patients who feel anxious under regional anesthesia
Patient Satisfaction According to Gender Female	83 Participants	25 Participants	—	—	—
Patient Satisfaction According to Gender Male	164 Participants	28 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 day

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

Outcome measures

Measure	Satisfaction n=247 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=53 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable Patients who feel comfortable under regional anesthesia	Excited Patients who feel excited under regional anesthesia	Anxious Patients who feel anxious under regional anesthesia
Patient Satisfaction According to Education Primary school	112 Participants	24 Participants	—	—	—
Patient Satisfaction According to Education Junior high school	32 Participants	8 Participants	—	—	—
Patient Satisfaction According to Education High school	59 Participants	15 Participants	—	—	—
Patient Satisfaction According to Education University	44 Participants	6 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 day

patient satisfaction according to the type of surgery under regional anesthesia

Outcome measures

Measure	Satisfaction n=247 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=53 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable Patients who feel comfortable under regional anesthesia	Excited Patients who feel excited under regional anesthesia	Anxious Patients who feel anxious under regional anesthesia
Patient Satisfaction According to the Type of Surgery General	56 Participants	16 Participants	—	—	—
Patient Satisfaction According to the Type of Surgery Orthopedic	51 Participants	9 Participants	—	—	—
Patient Satisfaction According to the Type of Surgery Gynecology & obstetric	38 Participants	16 Participants	—	—	—
Patient Satisfaction According to the Type of Surgery Urology	102 Participants	12 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 day

patient satisfaction according to past regional anesthesia experience under regional anesthesia

Outcome measures

Measure	Satisfaction n=247 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=53 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable Patients who feel comfortable under regional anesthesia	Excited Patients who feel excited under regional anesthesia	Anxious Patients who feel anxious under regional anesthesia
Patient Satisfaction According to Past Regional Anesthesia Experience yes	115 Participants	15 Participants	—	—	—
Patient Satisfaction According to Past Regional Anesthesia Experience no	132 Participants	38 Participants	—	—	—

SECONDARY outcome

Timeframe: 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.)

Outcome measures

Measure	Satisfaction n=247 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=53 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable Patients who feel comfortable under regional anesthesia	Excited Patients who feel excited under regional anesthesia	Anxious Patients who feel anxious under regional anesthesia
Patient Satisfaction According to Preoperative Information yes	241 Participants	44 Participants	—	—	—
Patient Satisfaction According to Preoperative Information no	6 Participants	9 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 day

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

Outcome measures

Measure	Satisfaction n=123 adverse events satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=37 adverse events dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable Patients who feel comfortable under regional anesthesia	Excited Patients who feel excited under regional anesthesia	Anxious Patients who feel anxious under regional anesthesia
Patient Satisfaction According to Intra-operative Adverse Events Hypotension	61 number of experienced adverse events	11 number of experienced adverse events	—	—	—
Patient Satisfaction According to Intra-operative Adverse Events Bradycardia	22 number of experienced adverse events	5 number of experienced adverse events	—	—	—
Patient Satisfaction According to Intra-operative Adverse Events Nausea-vomiting	36 number of experienced adverse events	12 number of experienced adverse events	—	—	—
Patient Satisfaction According to Intra-operative Adverse Events Pain	4 number of experienced adverse events	9 number of experienced adverse events	—	—	—

SECONDARY outcome

Timeframe: 1 day

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

Outcome measures

Measure	Satisfaction n=98 adverse events satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=19 adverse events dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable Patients who feel comfortable under regional anesthesia	Excited Patients who feel excited under regional anesthesia	Anxious Patients who feel anxious under regional anesthesia
Patient Satisfaction According to Recovery Room Adverse Events Hypotension	26 adverse events	4 adverse events	—	—	—
Patient Satisfaction According to Recovery Room Adverse Events Bradycardia	30 adverse events	6 adverse events	—	—	—
Patient Satisfaction According to Recovery Room Adverse Events Nausea-vomiting	14 adverse events	5 adverse events	—	—	—
Patient Satisfaction According to Recovery Room Adverse Events Pain	28 adverse events	4 adverse events	—	—	—

SECONDARY outcome

Timeframe: 1 day

Patients' mood state according to age

Outcome measures

Measure	Satisfaction n=137 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=20 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable n=109 Participants Patients who feel comfortable under regional anesthesia	Excited n=115 Participants Patients who feel excited under regional anesthesia	Anxious n=67 Participants Patients who feel anxious under regional anesthesia
Mood State According to Age 18-25	6 Participants	0 Participants	8 Participants	12 Participants	5 Participants
Mood State According to Age 26-35	16 Participants	5 Participants	11 Participants	26 Participants	16 Participants
Mood State According to Age 36-45	42 Participants	5 Participants	32 Participants	34 Participants	22 Participants
Mood State According to Age 46-55	36 Participants	5 Participants	24 Participants	19 Participants	10 Participants
Mood State According to Age 56-65	24 Participants	3 Participants	24 Participants	17 Participants	10 Participants
Mood State According to Age 66-75	13 Participants	2 Participants	10 Participants	7 Participants	4 Participants

SECONDARY outcome

Timeframe: 1 day

Patients' mood state according to gender

Outcome measures

Measure	Satisfaction n=137 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=20 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable n=109 Participants Patients who feel comfortable under regional anesthesia	Excited n=115 Participants Patients who feel excited under regional anesthesia	Anxious n=67 Participants Patients who feel anxious under regional anesthesia
Mood State According to Gender Female	45 Participants	8 Participants	33 Participants	48 Participants	28 Participants
Mood State According to Gender Male	92 Participants	12 Participants	76 Participants	67 Participants	39 Participants

SECONDARY outcome

Timeframe: 1 day

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

Outcome measures

Measure	Satisfaction n=137 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=20 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable n=109 Participants Patients who feel comfortable under regional anesthesia	Excited n=115 Participants Patients who feel excited under regional anesthesia	Anxious n=67 Participants Patients who feel anxious under regional anesthesia
Mood State According to Education Primary school	64 Participants	10 Participants	57 Participants	47 Participants	32 Participants
Mood State According to Education Junior high school	16 Participants	1 Participants	15 Participants	15 Participants	11 Participants
Mood State According to Education High school	31 Participants	7 Participants	21 Participants	37 Participants	14 Participants
Mood State According to Education University	26 Participants	2 Participants	16 Participants	16 Participants	10 Participants

SECONDARY outcome

Timeframe: 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.)

Outcome measures

Measure	Satisfaction n=137 Participants satisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Dissatisfaction n=20 Participants dissatisfied patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period	Comfortable n=109 Participants Patients who feel comfortable under regional anesthesia	Excited n=115 Participants Patients who feel excited under regional anesthesia	Anxious n=67 Participants Patients who feel anxious under regional anesthesia
Mood State According to Preoperative Information yes	134 Participants	17 Participants	106 Participants	110 Participants	60 Participants
Mood State According to Preoperative Information no	3 Participants	3 Participants	3 Participants	5 Participants	7 Participants

Adverse Events

Regional, Questionnaire

Serious events: 85 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Regional, Questionnaire n=300 participants at risk patients who underwent surgery under regional anesthesia. Questionnaire: Postoperative questionnaire, and records of complications in the peri-operative period
Cardiac disorders Bradycardia	10.7% 32/300 • Number of events 32 • 1 day adverse events (ie: bradycardia, hypotension, nausea-vomiting, pain) due to regional anesthesia were collected. However these events were not related to the participant's participation in the research (this research is a questionnaire).
Cardiac disorders hypotension	27.7% 83/300 • Number of events 83 • 1 day adverse events (ie: bradycardia, hypotension, nausea-vomiting, pain) due to regional anesthesia were collected. However these events were not related to the participant's participation in the research (this research is a questionnaire).
Gastrointestinal disorders nausea-vomitting	8.0% 24/300 • Number of events 24 • 1 day adverse events (ie: bradycardia, hypotension, nausea-vomiting, pain) due to regional anesthesia were collected. However these events were not related to the participant's participation in the research (this research is a questionnaire).
Surgical and medical procedures pain	12.0% 36/300 • Number of events 36 • 1 day adverse events (ie: bradycardia, hypotension, nausea-vomiting, pain) due to regional anesthesia were collected. However these events were not related to the participant's participation in the research (this research is a questionnaire).

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hande Aytuluk

Derince Eğitim Ve Araştırma Hastanesi

Phone: 5336515650

Email: handegrbz@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place