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

Sponsor
Cumhuriyet University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04386486
Collaborator
(none)
500
1
2
13.9
35.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Bathe anamnesis method
  • Other: standart anamnesis
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Screening
Official Title:
The Effect of BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns in Adults in Anesthesia Polyclinics
Actual Study Start Date :
Dec 13, 2017
Actual Primary Completion Date :
Dec 30, 2018
Actual Study Completion Date :
Feb 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: bathe group

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

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

Sham Comparator: standart anamnesis group

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

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

Outcome Measures

Primary Outcome Measures

  1. t-test [0-30 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria: A) ASA I-II patients

Exclusion Criteria:
  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cemil Ahmet Isbir Sivas Turkey 58140

Sponsors and Collaborators

  • Cumhuriyet University Hospital

Investigators

  • Study Director: Cemil A Isbir, M.D., Dr. at Cumhuriyet University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmet Cemil Isbir, Assoc. Prof., Cumhuriyet University Hospital
ClinicalTrials.gov Identifier:
NCT04386486
Other Study ID Numbers:
  • bathe-2019
First Posted:
May 13, 2020
Last Update Posted:
May 13, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmet Cemil Isbir, Assoc. Prof., Cumhuriyet University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2020