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

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.

Read the 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: Bariatric Surgery
Being tested: Guided Imagery Application
Keywords: bariatric surgery, Guided Imagery, Pain, Anxiety, Fear, Cortisol
Medical subject headings: Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Guided Imagery ApplicationDevice
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.

Study groups in NCT07157826
Study group	Role	What they receive
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 Receives: Device: Guided Imagery Application

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Aug 202525 Aug 2026

First posted5 Sep 2025
Study start25 Aug 2025 (estimated)
Primary completion25 Dec 2025 (estimated)
Study completion25 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
More trials run by Ataturk UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07157826
Sponsor's protocol ID: Rumeysa TORAMAN
Status last verified: Aug 2025
First submitted: 10 Aug 2025
Last updated: 5 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

RUMEYSA LALE TORAMAN

05050346050

ikizlertoraman@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
Lifestyle Adherence

All Bariatric Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07157826
Acronym / sponsor ID: Rumeysa TORAMAN
Conditions: Bariatric Surgery
Keywords: bariatric surgery, Guided Imagery, Pain, Anxiety, Fear, Cortisol
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 70 participants (estimated)
Lead sponsor: Ataturk UniversityUniversity, hospital or other
Study start: 25 Aug 2025 (estimated)
Primary completion: 25 Dec 2025 (estimated)
Study completion: 25 Aug 2026 (estimated)
First posted: 5 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Guided Imagery Application	Experimental	Device: Guided Imagery ApplicationOn 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

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Guided 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.	Device	Guided Imagery Application

Primary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Bariatric Surgery

Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effectiveness of an Early Postoperative Nurse-Led, Individualized Counseling Program on Lifestyle Adherence After Bariatric Surgery: A Randomized Controlled Trial
Lifestyle Adherence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

RUMEYSA LALE TORAMAN contact

05050346050

ikizlertoraman@gmail.com

Zeynep KARAMAN ÖZLÜ, Prof.Dr. contact

zynp_krmnzl@hotmail.com

RUMEYSA LALE TORAMAN principal investigator

Ataturk University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Guided Imagery Application in people with Bariatric Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact RUMEYSA LALE TORAMAN (05050346050, ikizlertoraman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Personal Information Form (time frame: up to 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07157826.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.