Anesthesia; ReactionBATHE MethodNCT04386486
BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns
A study testing Bathe anamnesis method and standart anamnesis in people with Anesthesia; Reaction and Anxiety Preoperative, run by Cumhuriyet University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Reaction, Anxiety Preoperative, Patient Satisfaction
- What is being tested?
- Bathe anamnesis method and standart anamnesis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Dec 2017to 10 Feb 2019
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns in Adults in Anesthesia Polyclinics
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.
Read the 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.
- Being tested
- Bathe anamnesis method, standart anamnesis
- Keywords
- preoperative anxiety, anesthesia anxiety, BATHE method, APAIS, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bathe anamnesis methodOther
BATHE anamnesis (BA) is applied to first group and preoperative examinations are completed.
standart anamnesisOther
standart anamnesis is applied to second group and preoperative examinations are completed.
| Study group | Role | What they receive |
|---|---|---|
| bathe group | Experimental | The patients were divided into two equal groups randomly first group is BATHE anamnesis group. Receives: Other: Bathe anamnesis method |
| standart anamnesis group | Sham comparator | The patients were divided into two equal groups randomly second group is standart anamnesis group. Receives: Other: standart anamnesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
t-test
when measurements taken from two independent groups are compared, the independent T-test was used.
Measured: 0-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start13 Dec 2017
- Primary completion30 Dec 2018
- Study completion10 Feb 2019
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 Anesthesia; ReactionStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Cemil Isbir, Cumhuriyet University Hospital
- Investigators
- Cemil A Isbir, M.D., Study director, Dr. at Cumhuriyet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386486
- Sponsor's protocol ID
- bathe-2019
- Acronym
- BATHE Method
- Status last verified
- May 2020
- First submitted
- 9 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share any data of any patients with other researchers.
Publications
DeMaria S Jr, DeMaria AP, Silvay G, Flynn BC. Use of the BATHE method in the preanesthetic clinic visit. Anesth Analg. 2011 Nov;113(5):1020-6. doi: 10.1213/ANE.0b013e318229497b. Epub 2011 Aug 24.
PubMed 21865495
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BATHE Method on Preoperative Anxiety, Patient Satisfaction and Individual Anesthesia Concerns in Adults in Anesthesia Polyclinics
- ClinicalTrials.gov ID
- NCT04386486
- Acronym / sponsor ID
- BATHE Method / bathe-2019
- Keywords
- preoperative anxiety, anesthesia anxiety, BATHE method, APAIS, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Cumhuriyet University HospitalUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 10 Feb 2019 (actual)
- First posted
- 13 May 2020 (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.
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.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bathe group | Experimental | Other: Bathe anamnesis methodThe patients were divided into two equal groups randomly first group is BATHE anamnesis group. |
| standart anamnesis group | Sham comparator | Other: standart anamnesisThe patients were divided into two equal groups randomly second group is standart anamnesis group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
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 anamnesis methodBATHE anamnesis (BA) is applied to first group and preoperative examinations are completed. | Other | bathe group |
| standart anamnesisstandart anamnesis is applied to second group and preoperative examinations are completed. | Other | standart anamnesis group |
Primary outcome
t-test
Time frame: 0-30 minutes
when measurements taken from two independent groups are compared, the independent T-test was used.
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 13 May 2020.
- Background: PubMed 21865495DeMaria S Jr, DeMaria AP, Silvay G, Flynn BC. Use of the BATHE method in the preanesthetic clinic visit. Anesth Analg. 2011 Nov;113(5):1020-6. doi: 10.1213/ANE.0b013e318229497b. Epub 2011 Aug 24.
- Individual participant dataSharing planned: No. There is no plan to share any data of any patients with other researchers.
Related trials for Anesthesia; Reaction
Enrolling by invitationObservational study
ETCO₂ Targeting and Cerebral Oxygenation
Airway Reactivity, Hemodynamic Stability During Anesthesia
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruiting
Effect of Serratus and Pectoralis II Plane Block Versus Pectoralis II Alone on Acute Postoperative Pain After Mastectomy
Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection
Recruiting
Effect of Tegileridine Versus Sufentanil as Analgesic Components on Opioid-Induced Cough During Anesthesia Induction
General Anesthetic Drug Adverse Reaction
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.
Cemil A Isbir, M.D. study director
Dr. at Cumhuriyet University Hospital
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 anamnesis method and standart anamnesis in people with Anesthesia; Reaction and Anxiety Preoperative, run by Cumhuriyet University 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 0 inclusion and 1 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 13 May 2020. 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. Some participants in this study may receive a placebo. 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?
t-test (time frame: 0-30 minutes). 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 NCT04386486, 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 13 May 2020.