Education and Information for Bariatric Surgery Patients

February 20, 2024 updated by: pinar ongun, Balikesir University

The Effect of Pre-admission Education Given to Bariatric Surgery Patients on Postoperative Recovery

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Balıkesir, Turkey, 38000
        • Pınar Ongün

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: Control group
The control group received standard care.
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.
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data collection form
Time Frame: preoperative phase
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)
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
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)
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pınar Ongün, Balıkesir Üniversitesi
  • Principal Investigator: Sibel Karaca Sivrikaya, Balıkesir Üniversitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

January 5, 2024

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Estimated)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

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)?

NO

IPD Plan Description

I can share the data whenever requested if it will be used in research such as meta-analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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