NCT03468517

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
463

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

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

January 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

December 11, 2017

Last Update Submit

March 20, 2018

Conditions

Anxiety State

Keywords

General AnaesthesiaPreoperative AnxietyBATHE method

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 hour

Secondary Outcomes (1)

  • Patient satisfaction score

    1 hour

Study Arms (2)

Control group

NO INTERVENTION

Standard preoperative evaluation process will continue without any intervention.

Bathe Group

ACTIVE COMPARATOR

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

Other: Bathe method:

Interventions

Bathe method:OTHER

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

Bathe Group

Eligibility Criteria

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

You may qualify if:

  • Patients \>18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katip Çelebi University İzmir Atatürk Training and Reseach Hospital

Izmir, 35360, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 18773778BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Pınar P Ayvat, MD

    Principal Investigator

    STUDY CHAIR

  • Derya DA Yurtlu, MD

    Investigator

    PRINCIPAL INVESTIGATOR

  • Yasemin Y Işık, MD

    Investigator

    PRINCIPAL INVESTIGATOR

  • Uğur U Özgürbüz, MD

    Investigator

    PRINCIPAL INVESTIGATOR

  • Fatma F Güntürkün, PhD

    Investigator

    PRINCIPAL INVESTIGATOR

  • Kaan K Katırcıoğlu, MD

    Investigator

    PRINCIPAL INVESTIGATOR

  • Mehmet M Kızılkaya, MD

    Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr, MD

Study Record Dates

First Submitted

December 11, 2017

First Posted

March 16, 2018

Study Start

January 1, 2016

Primary Completion

February 28, 2016

Study Completion

March 30, 2016

Last Updated

March 21, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)