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NCT Number: NCT06281990

Education and Information for Bariatric Surgery Patients

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pınar Ongün

Balıkesir, 38000, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral
  • 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.
  • When the patient was hospitalized, anxiety level with the Trait Anxiety scale and pain level with VAS were determined one day before surgery.
  • 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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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