NCT04386486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 9, 2020

Last Update Submit

May 9, 2020

Conditions

Keywords

preoperative anxietyanesthesia anxietyBATHE methodAPAISpatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • t-test

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

    0-30 minutes

Study Arms (2)

bathe group

EXPERIMENTAL

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

Other: Bathe anamnesis method

standart anamnesis group

SHAM COMPARATOR

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

Other: standart anamnesis

Interventions

BATHE anamnesis (BA) is applied to first group and preoperative examinations are completed.

bathe group

standart anamnesis is applied to second group and preoperative examinations are completed.

standart anamnesis group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cemil Ahmet Isbir

Sivas, 58140, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 21865495BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Cemil A Isbir, M.D.

    Dr. at Cumhuriyet University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

May 9, 2020

First Posted

May 13, 2020

Study Start

December 13, 2017

Primary Completion

December 30, 2018

Study Completion

February 10, 2019

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

There is no plan to share any data of any patients with other researchers.

Locations