The Effect of Guided Imagery on Bariatric Surgery Patients

NCT07157826 | Not Yet Recruiting

• 1 other identifier: Rumeysa TORAMAN
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bariatric Surgery

Keywords

bariatric surgery; Guided Imagery; Pain; Anxiety; Fear; Cortisol

Outcome Measures

Primary Outcomes (6)

• Personal Information Form

  The Personal Information Form, developed by the researcher based on a review of the relevant literature, consists of a total of 16 questions. It includes items related to gender, age, education level, marital status, and previous surgical history.

  up to 24 hours

• The Surgical Fear Scale

  Developed by Theunissen et al. in 2014 to assess the fear levels of patients scheduled for surgical procedures, this 8-item Likert-type scale evaluates short-term surgical fears with items 1-4 and long-term surgical fears with items 5-8. Each item is scored on a scale from 0 ("not afraid at all") to 10 ("very afraid"), resulting in a total score ranging from 0 to 80. Higher scores indicate greater levels of surgical fear (Theunissen et al., 2014). The Turkish validity and reliability study conducted by Bağdigen and Özlü (2018) reported a Cronbach's alpha coefficient of 0.93.

  up to 24 hours

• Richard-Campbell Sleep Questionnaire

  The Richard-Campbell Sleep Questionnaire was developed by Richards in 1987 and its Turkish validity and reliability study was conducted by Özlü and Özer in 2015 . The scale consists of 6 items that assess various aspects of nighttime sleep, including sleep depth, sleep latency, frequency of awakenings, duration of awakening after sleep onset, sleep quality, and noise level in the environment. Each item is scored on a scale from 0 to 100. However, when calculating the total score, the 6th item (noise level) is excluded, and the evaluation is based on the first 5 items. Higher scores indicate better sleep quality. The total score is obtained by dividing the sum of the item scores by the number of items. Scores ranging from 0 to 25 indicate very poor sleep quality, while scores between 76 and 100 indicate very good sleep quality.

  up to 24 hours

• Visual Analog Scale for Pain (VAS)

  Developed by Price et al. (1983), this scale measures the intensity of pain using a 10 cm vertical or horizontal line with endpoints labeled as "no pain" (0) and "worst possible pain" (10). The patient marks a point corresponding to their perceived pain intensity, and the distance from the "no pain" end to the marked point is measured in centimeters, representing the pain score. Higher scores indicate greater pain intensity.

  up to 24 hours

• State-Trait Anxiety İnventory (STAI-I, STAI-II)

  It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Oner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety).

  up to 24 hours

• Parameter Tracking Form

  Before and after bariatric surgery, patients' heart rate, blood pressure, and oxygen saturation will be measured and recorded in this form. In addition, to assess stress levels, blood cortisol measurements will be performed. Blood samples for cortisol will be collected in the morning (between 07:30-08:30) in appropriate tubes, promptly transported to the laboratory, and analyzed under cold chain conditions. Serum or plasma will be separated and analyzed using standard devices. All procedures will be carried out in the Erzurum City Hospital laboratory according to existing standard protocols and high-quality criteria, and results will be recorded.

  up to 24 hours

Study Arms (1)

Guided Imagery Application

EXPERIMENTAL

On the day of hospital admission for bariatric surgery, patients in the experimental group will be administered the Personal Information Form, the Surgical Fear Questionnaire, the Richard-Campbell Sleep Questionnaire, the Visual Analog Scale (VAS) to assess pain intensity, the State-Trait Anxiety Inventory, and the parameter recording form for vital signs through face-to-face interviews conducted by the researcher. Subsequently, in line with the literature, guided imagery sessions will be implemented a total of 10 times, each lasting 10-15 minutes, as follows: morning and evening before surgery, the morning of surgery, the evening of the same day after surgery, and morning and evening on the first, second, and third postoperative days. On the morning of surgery, the Surgical Fear Questionnaire, the Richard-Campbell Sleep Questionnaire, and the State Anxiety Inventory will be administered to collect data. After the completion of the guided imagery sessions, the Surgical Fear Questionna

Device: Guided Imagery Application

Interventions

Guided Imagery Application DEVICE

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 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.

Guided Imagery Application

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University

Erzurum, Palandöken, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• RUMEYSA LALE TORAMAN

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RUMEYSA LALE TORAMAN

CONTACT

05050346050; ikizlertoraman@gmail.com

Zeynep KARAMAN ÖZLÜ, Prof.Dr.

CONTACT

zynp_krmnzl@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: September 5, 2025
• Study Start: August 25, 2025
• Primary Completion: December 25, 2025
• Study Completion (Estimated): August 25, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)