Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07157826

The Effect of Guided Imagery on Bariatric Surgery Patients

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
Ataturk University · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEGuided Imagery ApplicationGuided 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 set their phones to airplane mode, and to inform their relatives not to interrupt them before starting the session. Headphones will be provided by the researcher for each patient. After the content of the audio recordings is created during the initial session, it will be recorded via phone and transferred as a file to the patients' phones, with instructions on how to use it. The audio recording will last approximately 15 to 20 minutes and will include relaxing, soft background music.

Timeline

Start date
2025-08-25
Primary completion
2025-12-25
Completion
2026-08-25
First posted
2025-09-05
Last updated
2025-09-05

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07157826. Inclusion in this directory is not an endorsement.