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Preoperative Anxiety and BATHE Method

Primary Purpose

Anxiety State

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bathe method:
Sponsored by
Izmir Ataturk Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety State focused on measuring General Anaesthesia, Preoperative Anxiety, BATHE method

Eligibility Criteria

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

Inclusion Criteria:

  • Patients >18 years old

Exclusion Criteria:

  • Not to accept to be involved in the study
  • Being illiterate
  • Having been diagnosed a psychiatric illness
  • Having a physical/psychiatric trauma within the last one year
  • Using sedative, antidepressant, antiepileptic substances or drugs
  • Having cooperation, understanding or hearing problems
  • Patients who were ASA PS >III

Sites / Locations

  • Katip Çelebi University İzmir Atatürk Training and Reseach Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Bathe Group

Arm Description

Standard preoperative evaluation process will continue without any intervention.

In the comparator group of patients, Bathe method will be applied at preoperative evaluation process.

Outcomes

Primary Outcome Measures

2 item State Trait Anxiety Intentory (STAI) Score Measure
State Trait Anxiety Intentory (STAI) Score Measure was applied before BATHE intervention. Then, State Trait Anxiety Intentory (STAI) Score Measure was again applied after BATHE intervention. Then, the change between STAI scores are assessed to understand whether BATHE intervention makes a difference or not.

Secondary Outcome Measures

Patient satisfaction score
Five point Likert scale were applied to determine patient satisfaction after preoperative anesthesia evaluation. Patient satisfaction is scored 11-55. (11=no satisfaction, 55=much satisfaction)

Full Information

First Posted
December 11, 2017
Last Updated
March 20, 2018
Sponsor
Izmir Ataturk Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03468517
Brief Title
Preoperative Anxiety and BATHE Method
Official Title
Does the Preoperative Anxiety Decrease With BATHE Method? A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
February 28, 2016 (Actual)
Study Completion Date
March 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Ataturk Training and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
The patients were randomized into "Bathe" and "Control" groups by using the closed envelope technique. Demographic data and pre-examination anxiety scores State- Trait Anxiety Inventory (STAI) are recorded as entrance STAI for all patients. Then they had routine preoperative evaluation. During these procedures, Bathe method was applied to the Bathe Group whereas it was not applied to the Control Group. After that post-examination, STAI scores were recorded as exit STAI and the patients were later asked questions about their contentment.
Detailed Description
Participants and Procedure: Before the study, approval from the ethics committee of Katip Celebi University Faculty of Medicine was received. 463 patients were included in the prospective randomized double blind study. To accept to be involved in the study, being above 18 years old and being literate were the criteria necessary to be involved in the study. Exclusion criteria were listed as below: Not to accept to be involved in the study, being under 18 years old, being illiterate, having been diagnosed a psychiatric illness, having a physical/psychiatric trauma within the last one year, using sedative, antidepressant, antiepileptic substances or drugs, having cooperation, understanding or hearing problems, belonging to American Society of Anesthesiologists (ASA) physical situation (PS) III and above. STAI Analysis: By randomization using the closed envelope technique, the envelopes have been prepared beforehand the patient examination. Sealed envelopes contained a specific number and a patient group defined for this number. Thus, patients were divided into two as 'bathe group' and 'control group' by simple randomization method and they were given one of these closed envelopes respectively. The demographic data of the patients which included their names-surnames, gender, age, educational background, income level, their previous anesthesia experience (no experience, with general anesthesia experience, with regional anesthesia experience, with both general and regional anesthesia experience) have been questioned. Following this, STAI anxiety questionnaire that was validated to Turkish language by Oner et al., has been applied in order to learn the patients' anxiety levels before preoperative evaluation and the result has been recorded as entrance STAI. Since we aimed to decrease operation anxiety of the patients, we only used state anxiety scale at that moment. After then, patients have been taken to anesthesia examination room. BATHE technique: All the patients were evaluated before the anaesthesia. Later, by opening the envelope of the patient, his/her group has been learned. Feedback has been given with empathetic statements to those in BATHE group after key questions and they have been informed about the possible outcomes . Bathe questions have been modelled by Hepner et al. and have been modified in order to be used in perioperative period. It was validated to Turkish language by Akturan et al. For the patients in the control group, the interview ended by routine preoperative evaluation (without applying BATHE technique). Satisfaction Questionnaire At the end of the examination, the STAI anxiety questionnaire (Exit STAI) was repeated for patients to measure their anxiety levels. In addition, satisfaction questionnaire, which was prepared by Leiblum et al., was also applied. Patients have been asked to rate their satisfaction level by using five point Likert scale. At the end, the bathe method has also been applied to the patients in control group as well. The reason for this procedure was to prevent the discrimination of the control group. Obviously, this did not change the results of the study as the satisfaction questionnaire was applied before the BATHE technique procedure for the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State
Keywords
General Anaesthesia, Preoperative Anxiety, BATHE method

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
463 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard preoperative evaluation process will continue without any intervention.
Arm Title
Bathe Group
Arm Type
Active Comparator
Arm Description
In the comparator group of patients, Bathe method will be applied at preoperative evaluation process.
Intervention Type
Other
Intervention Name(s)
Bathe method:
Intervention Description
BATHE technique, on the other hand, is one of the short therapeutic consultation techniques that strengthen the doctor-patient relationship. BATHE stands for the initials of the questions that include the titles for Background, Affect, Trouble, Handling and Empathy. It allows evaluating the physiological stress of the patients quickly. BATHE method necessitates an empathetic expression that includes the view of the patient in addition to asking the key questions by the doctor doing the interview
Primary Outcome Measure Information:
Title
2 item State Trait Anxiety Intentory (STAI) Score Measure
Description
State Trait Anxiety Intentory (STAI) Score Measure was applied before BATHE intervention. Then, State Trait Anxiety Intentory (STAI) Score Measure was again applied after BATHE intervention. Then, the change between STAI scores are assessed to understand whether BATHE intervention makes a difference or not.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Patient satisfaction score
Description
Five point Likert scale were applied to determine patient satisfaction after preoperative anesthesia evaluation. Patient satisfaction is scored 11-55. (11=no satisfaction, 55=much satisfaction)
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients >18 years old Exclusion Criteria: Not to accept to be involved in the study Being illiterate Having been diagnosed a psychiatric illness Having a physical/psychiatric trauma within the last one year Using sedative, antidepressant, antiepileptic substances or drugs Having cooperation, understanding or hearing problems Patients who were ASA PS >III
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pınar P Ayvat, MD
Organizational Affiliation
Principal Investigator
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Derya DA Yurtlu, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasemin Y Işık, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Uğur U Özgürbüz, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatma F Güntürkün, PhD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kaan K Katırcıoğlu, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehmet M Kızılkaya, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katip Çelebi University İzmir Atatürk Training and Reseach Hospital
City
İzmir
ZIP/Postal Code
35360
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18773778
Citation
Leiblum SR, Schnall E, Seehuus M, DeMaria A. To BATHE or not to BATHE: patient satisfaction with visits to their family physician. Fam Med. 2008 Jun;40(6):407-11.
Results Reference
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Preoperative Anxiety and BATHE Method

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