Clinical trial NCT03468517: Preoperative Anxiety and BATHE Method
Official title: Does the Preoperative Anxiety Decrease With BATHE Method? A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Keywords: General Anaesthesia
Preoperative Anxiety
BATHE method
Lead sponsor: Izmir Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 2 item State Trait Anxiety Intentory (STAI) Score Measure
timeFrame: 1 hour
Secondary outcomes:
measure: Patient satisfaction score
timeFrame: 1 hour
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Katip Çelebi University İzmir Atatürk Training and Reseach Hospital
Study officials:
affiliation: Principal Investigator
name: Pınar P Ayvat, MD
role: STUDY_CHAIR
affiliation: Investigator
name: Derya DA Yurtlu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Yasemin Y Işık, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Uğur U Özgürbüz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Fatma F Güntürkün, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Kaan K Katırcıoğlu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Mehmet M Kızılkaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.