Education and Information for Bariatric Surgery Patients

NCT06281990 | Completed

• 1 other identifier: BAUN-SBF-PO-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to investigate the effect of pre-admission education given to bariatric surgery (laparoscopic sleeve gastrectomy) patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs.

Conditions

Bariatric Surgeries; Education of Patients

Keywords

patient education; bariatric surgery; laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcomes (3)

• Data collection form

  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

  preoperative phase

• Visual Analog Scale (VAS)

  Pain assessment was performed with VAS. "0" indicates no pain, and "10" indicates the most severe unbearable pain.

  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

• State-Trait Anxiety Inventory (STAI)

  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.

  Anxiety level with STAI were determined one day before surgery; postoperatively, the patient's anxiety level with the STAI scale one day after surgery

Study Arms (2)

Control group

NO INTERVENTION

The control group received standard care.

Intervention group

EXPERIMENTAL

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.

Behavioral: Education

Interventions

Education BEHAVIORAL

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. 2. When the patient was hospitalized, anxiety level with the Trait Anxiety scale and pain level with VAS were determined one day before surgery. 3. Postoperatively, the patient's pain level before analgesics every 4-6hours for 2days, 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being conscious
• not having a diagnosis of psychiatric disease,
• being 18 years of age or older,
• undergoing their first bariatric surgery,

You may not qualify if:

• 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

Sponsors & Collaborators

• Balikesir University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Pınar Ongün

Balıkesir, 38000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Pınar Ongün

  Balıkesir Üniversitesi

  PRINCIPAL INVESTIGATOR

• Sibel Karaca Sivrikaya

  Balıkesir Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The researcher (YY) provided education in the outpatient clinic. The nurses and surgical team members working in the surgical ward were blinded (FÇ in the research group was blinded).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: There are two groups in the research: control and intervention groups.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 28, 2024
• Study Start: December 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: January 5, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)