Anxiety StateNCT03468517
Preoperative Anxiety and BATHE Method
A study testing Bathe method: in people with Anxiety State, run by Izmir Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety State
- What is being tested?
- Bathe method:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 30 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Katip Çelebi University İzmir Atatürk Training and Reseach Hospital
Izmir, 35360
About this study
Official title: Does the Preoperative Anxiety Decrease With BATHE Method? A Prospective Randomized Study
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.
Read the 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.
- Conditions
- Anxiety State
- Being tested
- Bathe method:
- Keywords
- General Anaesthesia, Preoperative Anxiety, BATHE method
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Bathe method: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (1)
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)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Jan 2016
- Primary completion28 Feb 2016
- Study completion30 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Arslan Yurtlu, Izmir Ataturk Training and Research Hospital
- Investigators
- Pınar P Ayvat, MD, Study chair, Principal InvestigatorDerya DA Yurtlu, MD, Principal investigator, InvestigatorYasemin Y Işık, MD, Principal investigator, InvestigatorUğur U Özgürbüz, MD, Principal investigator, InvestigatorFatma F Güntürkün, PhD, Principal investigator, InvestigatorKaan K Katırcıoğlu, MD, Principal investigator, InvestigatorMehmet M Kızılkaya, MD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468517
- Sponsor's protocol ID
- KÇÜ-IATRH
- Status last verified
- Mar 2018
- First submitted
- 11 Dec 2017
- Last updated
- 21 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18773778
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Preoperative Anxiety Decrease With BATHE Method? A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03468517
- Acronym / sponsor ID
- KÇÜ-IATRH
- Conditions
- Anxiety State
- Keywords
- General Anaesthesia, Preoperative Anxiety, BATHE method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Izmir Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 30 Mar 2016 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard preoperative evaluation process will continue without any intervention. |
| Bathe Group | Active comparator | Other: Bathe method:In the comparator group of patients, Bathe method will be applied at preoperative evaluation process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >18 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bathe method: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 | Other | Bathe Group |
Primary outcome
2 item State Trait Anxiety Intentory (STAI) Score Measure
Time frame: 1 hour
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 secondary outcome
Patient satisfaction score
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Background: PubMed 18773778Leiblum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pınar P Ayvat, MD study chair
Principal Investigator
Derya DA Yurtlu, MD principal investigator
Investigator
Yasemin Y Işık, MD principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bathe method: in people with Anxiety State, run by Izmir Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 item State Trait Anxiety Intentory (STAI) Score Measure (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.