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BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns (BATHE Method)

Primary Purpose

Anesthesia; Reaction, Anxiety Preoperative, Patient Satisfaction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bathe anamnesis method
standart anamnesis
Sponsored by
Cumhuriyet University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anesthesia; Reaction focused on measuring preoperative anxiety, anesthesia anxiety, BATHE method, APAIS, patient satisfaction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: A) ASA I-II patients

Exclusion Criteria:

A) ASA III-IV B) illiterate patients C) patients with known psychiatric disorders D) patients with chronic sedative E) antipsychotic drug use F) patients with a history of going to psychiatry in the last year G) patients with any cancer diagnosis were not included in the study.

Sites / Locations

  • Cemil Ahmet Isbir

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

bathe group

standart anamnesis group

Arm Description

The patients were divided into two equal groups randomly first group is BATHE anamnesis group.

The patients were divided into two equal groups randomly second group is standart anamnesis group.

Outcomes

Primary Outcome Measures

t-test
when measurements taken from two independent groups are compared, the independent T-test was used.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2020
Last Updated
May 9, 2020
Sponsor
Cumhuriyet University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04386486
Brief Title
BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns
Acronym
BATHE Method
Official Title
The Effect of BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns in Adults in Anesthesia Polyclinics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
February 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study the goal is to determine the causes of concern among the patients who will undergo surgical operations and receive general anesthesia, to gauge their preoperative anxiety levels and to study the effects of the BATHE method on preoperative anxiety and patient satisfaction.
Detailed Description
In this study the goal is to determine the causes of concern among the patients who will undergo surgical operations and receive general anesthesia, to gauge their preoperative anxiety levels and to study the effects of the BATHE method on preoperative anxiety and patient satisfaction. 500 patients who were planned to undergo elective surgery and under general anesthesia as anesthesia method were included in the study. Demographic data of patients, their three biggest fears of anesthesia and APAIS scores were recorded. The patients were divided into two groups, they underwent BATHE anamnesis or standard anamnesis methods according to their groups, then their APAIS and patient satisfaction scores were recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Reaction, Anxiety Preoperative, Patient Satisfaction
Keywords
preoperative anxiety, anesthesia anxiety, BATHE method, APAIS, patient satisfaction

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bathe group
Arm Type
Experimental
Arm Description
The patients were divided into two equal groups randomly first group is BATHE anamnesis group.
Arm Title
standart anamnesis group
Arm Type
Sham Comparator
Arm Description
The patients were divided into two equal groups randomly second group is standart anamnesis group.
Intervention Type
Other
Intervention Name(s)
Bathe anamnesis method
Intervention Description
BATHE anamnesis (BA) is applied to first group and preoperative examinations are completed.
Intervention Type
Other
Intervention Name(s)
standart anamnesis
Intervention Description
standart anamnesis is applied to second group and preoperative examinations are completed.
Primary Outcome Measure Information:
Title
t-test
Description
when measurements taken from two independent groups are compared, the independent T-test was used.
Time Frame
0-30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A) ASA I-II patients Exclusion Criteria: A) ASA III-IV B) illiterate patients C) patients with known psychiatric disorders D) patients with chronic sedative E) antipsychotic drug use F) patients with a history of going to psychiatry in the last year G) patients with any cancer diagnosis were not included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cemil A Isbir, M.D.
Organizational Affiliation
Dr. at Cumhuriyet University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Cemil Ahmet Isbir
City
Sivas
ZIP/Postal Code
58140
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share any data of any patients with other researchers.
Citations:
PubMed Identifier
21865495
Citation
DeMaria S Jr, DeMaria AP, Silvay G, Flynn BC. Use of the BATHE method in the preanesthetic clinic visit. Anesth Analg. 2011 Nov;113(5):1020-6. doi: 10.1213/ANE.0b013e318229497b. Epub 2011 Aug 24.
Results Reference
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BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns

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