- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06281990
Education and Information for Bariatric Surgery Patients
The Effect of Pre-admission Education Given to Bariatric Surgery Patients on Postoperative Recovery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim: The study aimed to investigate the effect of pre-admission education given to laparoscopic sleeve gastrectomy patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs.
Materials and Methods: This randomized, controlled, experimental, single-blinded study was conducted with 68 patients who met the inclusion criteria and underwent laparoscopic sleeve gastrectomy in the general surgery clinic of a university hospital between December 2022 and October 2023. The CONSORT checklist was used as a guide. Data were collected using the "Perioperative Form," "Visual Analog Scale, and "State-Trait Anxiety Scale" All patients were operated on by the same physicians and received standard perioperative care. Intervention group patients were informed and educated about the surgical process in the outpatient clinic. Anxiety levels were determined one day before surgery. In the postoperative period, vital signs, anxiety, and pain levels were measured 8 times during 48 hours.
Stage 1: Patients who were planned to undergo sleeve gastrectomy surgery were informed about the perioperative period in an appropriate room when they came to the outpatient clinic 2-4 weeks before surgery and were educated about the exercises to be performed before and after surgery. The content of this education included pain management, breathing exercises (use of trifle, deep breathing, coughing), foot rotation, and leg exercises. In addition, the education book prepared by the researchers was given to the patients to make the education and information permanent until the day of surgery.
Stage 2: When the patient was hospitalized, anxiety level with the Trait Anxiety Scale and pain level with VAS were determined one day before surgery.
Stage 3: Postoperatively, the patient's pain level before analgesics every 4-6 hours for 2 days, the patient's anxiety level with the State Anxiety Scale one day after surgery, the development of complications in the postoperative period, vital signs were evaluated, and the duration of hospitalization was recorded
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Balıkesir, Turkey, 38000
- Pınar Ongün
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- being conscious
- not having a diagnosis of psychiatric disease,
- being 18 years of age or older,
- undergoing their first bariatric surgery,
Exclusion Criteria:
- not being conscious
- Having a diagnosis of psychiatric disease,
- Being 18 years of age or younger,
- Not having bariatric surgery for the first time
- to be reoperated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
The control group received standard care.
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Experimental: Intervention group
1:Patients who were planned to undergo sleeve gastrectomy surgery were informed about the perioperative period when they came to the outpatient clinic2-4weeks before surgery and were educated about the exercises to be performed before and after surgery.
The content of this education included pain management, breathing exercises,foot rotation, and leg exercises.
In addition, the education book prepared by the researchers was given to the patients to make the education and information permanent until the day of surgery.
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|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Data collection form
Time Frame: preoperative phase
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It consists of a total of 25 questions, including questions such as age, gender, educational status, previous surgery, counseling and training status, duration of surgery, and postoperative complications, vital sigs
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preoperative phase
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Visual Analog Scale (VAS)
Time Frame: Pain level with VAS were determined one day before surgery; postoperatively, the patient's pain level before analgesics every 4-6 hours for 2 days
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Pain assessment was performed with VAS.
"0" indicates no pain, and "10" indicates the most severe unbearable pain.
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Pain level with VAS were determined one day before surgery; postoperatively, the patient's pain level before analgesics every 4-6 hours for 2 days
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State-Trait Anxiety Inventory (STAI)
Time Frame: Anxiety level with STAI were determined one day before surgery; postoperatively, the patient's anxiety level with the STAI scale one day after surgery
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The inventory measures state and trait anxiety levels in normal and abnormal individuals.
Turkish validity-reliability study was conducted.
The STAI consists of two scales of twenty items each, measuring state and trait anxiety levels.
The "STAI FORM" questionnaire form of the STAI scale used to measure the state anxiety of patients will be used in the study.
The State Anxiety Scale determines how an individual feels at a given moment and under certain conditions.
Trait Anxiety Inventory is a measurement tool consisting of statements that indicate how a person usually feels.
In answering the State-Trait Anxiety Scale, one is asked to select and mark one of the options "not at all, a little, a lot, completely" according to the severity of the feelings, thoughts, or behaviors expressed by the items.
Responses range from 1 to 4. A high score indicates a high level of anxiety.
A high score indicates a "high anxiety" level, and a low score indicates a "low anxiety" level.
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Anxiety level with STAI were determined one day before surgery; postoperatively, the patient's anxiety level with the STAI scale one day after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pınar Ongün, Balıkesir Üniversitesi
- Principal Investigator: Sibel Karaca Sivrikaya, Balıkesir Üniversitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BAUN-SBF-PO-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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