Education and Information for Bariatric Surgery Patients

NCT ID: NCT06281990

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-01-05

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.

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

Conditions

Bariatric Surgeries; Education of Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control group

The control group received standard care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: 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.

Interventions

Education

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 Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Balikesir University

OTHER

Sponsor Role: lead

Responsible Party

pinar ongun

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pınar Ongün

Role: PRINCIPAL_INVESTIGATOR

Balıkesir Üniversitesi

Sibel Karaca Sivrikaya

Role: PRINCIPAL_INVESTIGATOR

Balıkesir Üniversitesi

Locations

Pınar Ongün

Balıkesir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BAUN-SBF-PO-01

Identifier Type: -

Identifier Source: org_study_id