SurgeryAnxietyNCT06629571
The Effect of Preoperative Education on Anxiety
A study testing Education in people with Surgery and Anxiety, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aimed to evaluate the effect of preoperative education on anxiety levels in patients undergoing abdominal surgery at a training hospital in Istanbul. The study population included patients admitted between January and June 2024. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the general surgery clinic for abdominal surgery in category A-B-C
- must be over the age of 18
- To be literate- to be a writer
- Being conscious
- Who does not have a psychiatric disorder
Who cannot join
- Exit the research during the study,
- Group D and E abdominal surgery has been performed
- don't be under the age of 18
- Unconscious patient,
- Who has a psychiatric disorder
- Patients with communication disabilities or who cannot speak Turkish were determined as patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to Patients Before Abdominal Surgery on Anxiety: A Randomized Controlled Study
This randomized controlled study aimed to evaluate the effect of preoperative education on anxiety levels in patients undergoing abdominal surgery at a training hospital in Istanbul. The study population included patients admitted between January and June 2024. After power analysis, patients were divided into experimental (n=40) and control (n=41) groups. The experimental group received preoperative information, while the control group received standard care. Anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI). Data were analyzed with SPSS, using tests such as the Mann-Whitney U and Wilcoxon Sign tests.
Read the detailed description
As a result of this study, the anxiety levels of patients who received preoperative information training in the prevention or reduction of anxiety were found to be lower than patients who received routine care. The lower score indicated that they experienced less anxiety or were able to manage their anxiety in the experimental group.
- Being tested
- Education
- Keywords
- SurgeryAnxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Also called Surgery Education
Training for the patient before surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patient education Receives: Other: Education |
| Control | No intervention | No patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAI Form TX I,STAI Form TX II
In the scoring of both scales, the total score of reversed statements is subtracted from the total score obtained from direct statements, and 50 points are added as a fixed value for STAI TX-I and 35 points for STAI TX-II. The score obtained as a result of this calculation is the individual's anxiety score. The scores obtained from both scales theoretically vary between 20 and 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety. The STAI TX-I threshold is 39-40 points. Mild anxiety is between 20-31 points, moderate anxiety is between 32-42 points, and anxiety is above 42-44 points. Since it shows how the person feels at that moment, regardless of the situation and conditions they are in, the threshold is accepted as 44-45 points in patients in the pre-operative period. A score between 40-59 points is considered moderate, and a score between 60-80 points is considered high.
Measured: 1 Day before the operation and 1 day after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jan 2024
- Primary completion31 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629571
- Sponsor's protocol ID
- MarmaraU Banu Gümüş01
- Acronym
- Anxiety
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Patients Before Abdominal Surgery on Anxiety: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06629571
- Acronym / sponsor ID
- Anxiety / MarmaraU Banu Gümüş01
- Keywords
- SurgeryAnxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Oct 2024 (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.
This randomized controlled study aimed to evaluate the effect of preoperative education on anxiety levels in patients undergoing abdominal surgery at a training hospital in Istanbul. The study population included patients admitted between January and June 2024. After power analysis, patients were divided into experimental (n=40) and control (n=41) groups. The experimental group received preoperative information, while the control group received standard care. Anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI). Data were analyzed with SPSS, using tests such as the Mann-Whitney U and Wilcoxon Sign tests.
Detailed description
As a result of this study, the anxiety levels of patients who received preoperative information training in the prevention or reduction of anxiety were found to be lower than patients who received routine care. The lower score indicated that they experienced less anxiety or were able to manage their anxiety in the experimental group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: EducationPatient education |
| Control | No intervention | –No patient education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission to the general surgery clinic for abdominal surgery in category A-B-C
- must be over the age of 18
- To be literate- to be a writer
- Being conscious
- Who does not have a psychiatric disorder
Key exclusion criteria (6 listed)
- Exit the research during the study,
- Group D and E abdominal surgery has been performed
- don't be under the age of 18
- Unconscious patient,
- Who has a psychiatric disorder
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 |
|---|---|---|
| EducationAlso: Surgery EducationTraining for the patient before surgery | Other | Experimental |
Primary outcome
STAI Form TX I,STAI Form TX II
Time frame: 1 Day before the operation and 1 day after the operation
In the scoring of both scales, the total score of reversed statements is subtracted from the total score obtained from direct statements, and 50 points are added as a fixed value for STAI TX-I and 35 points for STAI TX-II. The score obtained as a result of this calculation is the individual's anxiety score. The scores obtained from both scales theoretically vary between 20 and 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety. The STAI TX-I threshold is 39-40 points. Mild anxiety is between 20-31 points, moderate anxiety is between 32-42 points, and anxiety is above 42-44 points. Since it shows how the person feels at that moment, regardless of the situation and conditions they are in, the threshold is accepted as 44-45 points in patients in the pre-operative period. A score between 40-59 points is considered moderate, and a score between 60-80 points is considered high.
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 8 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Surgery and Anxiety, run by Marmara University 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 5 inclusion and 6 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 8 Oct 2024. 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?
STAI Form TX I,STAI Form TX II (time frame: 1 Day before the operation and 1 day after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2024.