Condition category
Surgery
Date applied
15/02/2018
Date assigned
19/02/2018
Last edited
19/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients often feel anxiety prior to undergoing surgery. The reason for the anxiety can be both anesthesia used to numb the pain and the actual surgery. The preoperative anxiety that patients have can cause side effects. It is important for the reasons of anxiety to help them in future operations. The aim of this study is to investigate the preoperative patient anxiety and patients fear of anesthesia.

Who can participate?
Adults aged 18 to 95 who are scheduled to undergo elective surgery.

What does the study involve?
Participants are asked to fill out a short questionnaire at the anesthesia clinic about their feelings of anxiety prior to undergoing anesthesia. They are asked if they had received anesthesia before, if they have surgical briefing, and the cause of their anxiety.

What are the possible benefits and risks of participating?
The potential benefit is we can decrease participants anxiety with our interviews. There are no side effects of participating to our study.

Where is the study run from?
Ahi Evran University Medical Faculty (Turkey)

When is the study starting and how long is it expected to run for?
February 2016 to July 2017

Who is funding the study?
Ahi Evran University Medical Faculty (Turkey)

Who is the main contact?
Professor Ipek Edipoglu (Scientific)
dripeks@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ipek Saadet Edipoglu

ORCID ID

Contact details

Department of Anesthesiology
Suleymaniye Obstetrics & Pediatrics Training and Research Hospital Telsiz Mahallesi
Balıklı Kazlıçeşme Yolu Cd. No:1
Zeytinburnu
Istanbul
34020
Turkey

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

study no:2010-05/04

Study information

Scientific title

Evaluation of preoperative anxiety and fear of anesthesia using the Amsterdam preoperative anxiety and information scale score: a prospective cohort stud

Acronym

Study hypothesis

The aim of this study is to investigate how the patient's age, gender, the operation, surgical briefing, type of anesthesia recommended for the operation ahead, patient's prior anesthesia experience affect the patient's anxieties regarding anesthesia and surgery.

Ethics approval

Ethics Committee of Ahi Evran University on 27/04/2016, ref: 2016-05/04

Study design

Observational cross sectional cohort study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Preoperative anxiety and patients' fear of anesthesia

Intervention

Interviews with the patients are performed when they came to anesthesia clinic for preoperative examination, under the supervision of a specialist anesthetist.

For the study, The Amsterdam Preoperative Anxiety and Information Scale (APAIS), which comprises 6 statements, is used. The answers are evaluated in two scales; the anxiety score and the desire for information score. Anxiety score was obtained by calculating the total scores assigned to the expressions " I am worried about the anesthesic", "The anesthesic is on my mind continually", "I am worried about the procedure", "The procedure is on my mind continually", to measure the patient's level of anxiety regarding the anesthesia and surgery. Desire for information score is obtained by calculating the total scores assigned to the expressions "I would like to know as much as possible about the anesthesic " and "I would like to know as much as possible about the procedure “to measure the patient's level of desire for information regarding the anesthesia and surgery. Higher scores indicate higher levels of anxiety and desire for information. Answers to the statements were evaluated with Likert Scale. (1-Not at all… ,5-Extremely).

In addition, participants are asked whether they had received anesthesia due to any reason, if so, the type of anesthesia, and whether they received surgical briefing. Which anesthetic method recommended to the patient for the surgery they will undergo in the preoperative anesthesia clinic is recorded. Then, participants are asked about the cause of their anxiety regarding the anesthesia.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measure

1. Demographics is measured using the patient notes at the preoperative anesthesia visit
2. Type of anaesthesia patient notes is measured using at the preoperative anesthesia visit
3. Prior experience with anaesthesia patient interviews is measured using at the preoperative anesthesia visit
4. Anxiety regarding anaesthesia is measured using APAIS (Amsterdam preoperative anxiety and information scale) at the preoperative anesthesia visit.

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

20/02/2016

Overall trial end date

20/07/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. ASA I-III
2. Adult patients who are scheduled to undergo elective surgery in our hospital
3. Adequate language skills for the interview were included in our study
4. 18-95 (all adults)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Pediatric patients
2. Patients who did not give consent
3. Patients with mental retardation
4. Alzheimer's disease
5. Dementia or psychiatric disorders
6. Emergency and ASA-IV patients

Recruitment start date

28/05/2016

Recruitment end date

20/05/2017

Locations

Countries of recruitment

Turkey

Trial participating centre

Ahi Evran University Medical Faculty
Department of Anesthesiology and Intensive Care Medicine
Kirsehir
40100
Turkey

Sponsor information

Organisation

Ahi Evran University Medical Faculty

Sponsor details

Department of Anesthesiology and Intensive Care Medicine
Bağbaşı Mahallesi
Şht. Sahir Kurutluoğlu Cd.
Merkez
Kirsehir
40100
Turkey

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Ahi Evran University Medical Faculty clinical investigations

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. Additional documents will not be available.

IPD sharing treatment:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Ipek S. Edipoglu at dripeks@yahoo.com.

Intention to publish date

20/07/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes