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Not yet recruiting NCT07157826

The Effect of Guided Imagery on Bariatric Surgery Patients

No phase Interventional Bariatric Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guided Imagery Application.
Who it may be relevant to
Registry conditions: Bariatric Surgery. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Guided Imagery on Pain, Anxiety, Fear, Sleep Quality, Vital Signs, and Cortisol Levels in Patients Undergoing Bariatric Surgery: A Randomized Controlled Trial

Overview

The study will be conducted using a randomized controlled experimental design with experimental and control groups. Data will be collected between August 2025 and March 2026 in the General Surgery Clinic of Erzurum City Hospital. The study population will consist of patients who have undergone bariatric surgery at Erzurum City Hospital. A priori power analysis was performed to determine the sample size. According to the power analysis, based on Cohen's (Cohen, 2013) medium effect size of 0.5, with a significance level of 0.05, a 95% confidence interval, and 95% power to represent the population, it was determined that the study sample should include a total of 70 patients, with 35 patients in each group.

Detailed description

The World Health Organization (WHO) defines obesity as an abnormal or excessive accumulation of fat in the body that may impair health. Furthermore, a body mass index (BMI) of 30 kg/m² or higher is classified as obesity, a BMI of 40 kg/m² or higher as morbid obesity, and a BMI of 50 kg/m² or higher as super obesity. Obesity is a disease with an increasing global prevalence that reduces both the quality and the length of life. Over the past 10-15 years, the rising prevalence of obesity has increased morbidity rates, adversely affected quality of life, and shortened life expectancy. This situation has turned obesity into a serious public health problem requiring urgent attention.To combat obesity, which negatively affects all body systems, methods such as medical nutrition therapy (diet), therapeutic exercise, behavioral modification therapies, and pharmacological treatments are used. In patients who do not achieve adequate results from medical and conservative approaches, surgical interventions are recommended. Influenced by social media and in pursuit of an easy and rapid solution for weight loss, obese patients often prefer surgical methods (bariatric surgery). The lack of guidance from healthcare teams regarding surgery and insufficient therapeutic communication with patients can lead to anxiety and depression during hospitalization. Pharmacological and non-pharmacological approaches can prevent disease- and surgery-related symptoms, reduce anxiety, and contribute to improved sleep quality. These methods provide emotional, mental, social, and behavioral benefits to patients. Techniques such as hypnosis, biofeedback, meditation, and imagery enhance the interaction between the body and mind, thereby promoting healing. These practices activate the body's self-healing potential by influencing the mind. Guided imagery allows patients to feel happy, comfortable, peaceful, and safe, and to develop positive thoughts. It can be applied with soft background music to facilitate relaxation and help patients distance themselves from negative thoughts. Guided imagery is a mind-body intervention that uses the patient's imagination and mental processes to create a mental representation of an object, place, event, or situation perceived through the senses. It is considered a relaxation technique focusing on the interaction between the brain, mind, body, and behavior. Patients are instructed to focus on pleasant images that replace negative or stressful emotions. Guided imagery can be self-directed, facilitated by a professional, or delivered through a recording.This study was planned considering the need for evidence on the use of guided imagery in preoperative and postoperative care in the context of nursing practice. Given the mind-body connection between preoperative anxiety and major elective surgical procedures, it is hypothesized that guided imagery may be effective in reducing pain, anxiety, fear, and improving sleep quality, cortisol levels, blood glucose, and vital signs in patients undergoing bariatric surgery before and after the operation.

Interventions

  • Device Guided Imagery Application
    Guided Imagery Intervention: Scenario-based guided imagery, one of the guided imagery techniques, will be utilized. The scenario will be developed with input from experts to promote functional recovery. Expert opinions will be obtained from a psychologist and a psychiatric nurse. The scenario will begin with breathing exercises and continue with the "safe place" technique. Patients will be instructed to listen to the audio recording using headphones in an environment free from disturbances, to

Primary outcome measures

  • Personal Information Form [Time frame: up to 24 hours]
  • The Surgical Fear Scale [Time frame: up to 24 hours]
  • Richard-Campbell Sleep Questionnaire [Time frame: up to 24 hours]
  • Visual Analog Scale for Pain (VAS) [Time frame: up to 24 hours]
  • State-Trait Anxiety İnventory (STAI-I, STAI-II) [Time frame: up to 24 hours]
  • Parameter Tracking Form [Time frame: up to 24 hours]

Eligibility criteria

Inclusion criteria

  • Willingness to participate in the study
  • Ability to communicate verbally
  • No history of psychiatric disorders
  • Undergoing laparoscopic bariatric surgery using the Sleeve Gastrectomy method
  • Ability to use a smartphone
  • No prior experience with guided imagery intervention

Exclusion criteria

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Atatürk University — Erzurum

Identifiers

NCT: NCT07157826 · Rumeysa TORAMAN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗