Evaluation of preoperative anxiety and fear of anesthesia using Apais score

ISRCTN ISRCTN43960422
DOI https://doi.org/10.1186/ISRCTN43960422
Secondary identifying numbers study no:2010-05/04
Submission date
15/02/2018
Registration date
19/02/2018
Last edited
14/09/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Contact information

Prof Ipek Saadet Edipoglu
Scientific

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

Study information

Study designObservational cross sectional cohort study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation of preoperative anxiety and fear of anesthesia using the Amsterdam preoperative anxiety and information scale score: a prospective cohort stud
Study hypothesisThe 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(s)Ethics Committee of Ahi Evran University on 27/04/2016, ref: 2016-05/04
ConditionPreoperative anxiety and patients' fear of anesthesia
InterventionInterviews 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 typeBiological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure1. 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 measuresThere are no secondary outcome measures.
Overall study start date20/02/2016
Overall study end date20/07/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit95 Years
SexBoth
Target number of participants600
Participant inclusion criteria1. 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 exclusion criteria1. 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 date28/05/2016
Recruitment end date20/05/2017

Locations

Countries of recruitment

  • Türkiye

Study participating centre

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

Sponsor information

Ahi Evran University Medical Faculty
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/05rrfpt58

Funders

Funder type

Hospital/treatment centre

Ahi Evran University Medical Faculty clinical investigations

No information available

Results and Publications

Intention to publish date20/07/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal. Additional documents will not be available.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 11/09/2018 Yes No

Editorial Notes

14/09/2018: Publication reference added.