EndoscopyNCT07261839
Effect of Visualized Meditation on Anxiety, Pain, and Comfort in Patients Undergoing Endoscopy
A study testing Visualized meditation in people with Endoscopy and Pain, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Endoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of many diseases and plays a crucial role in the diagnosis and treatment of upper gastrointestinal disorders. Sometimes, endoscopy may be the only option for detecting certain diseases of the stomach and larynx. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Visualized meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18, with no hearing impairment,
- Students undergoing endoscopy for the first time,
- Not diagnosed with a psychiatric disorder and therefore not on medication,
- Willing to participate in the study
Who cannot join
- Patients who refused to participate in the study, underwent endoscopy for biopsy, or received deep sedation.
- Patients who volunteered to participate and then wished to withdraw from the study at any stage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Şehitkamil, 27310
About this study
Endoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of many diseases and plays a crucial role in the diagnosis and treatment of upper gastrointestinal disorders. Sometimes, endoscopy may be the only option for detecting certain diseases of the stomach and larynx. However, for many patients, endoscopy is considered an invasive, highly painful, and extremely uncomfortable procedure. Furthermore, anxiety and fear felt before the procedure can cause physical and emotional discomfort, disrupt patient comfort, and cause pain.
Read the detailed description
Endoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of various gastrointestinal disorders and plays a critical role, particularly in the evaluation of upper gastrointestinal system pathologies. In certain clinical situations, endoscopy may be the only reliable method for identifying diseases occurring in the stomach, esophagus, and larynx. Despite its diagnostic and therapeutic value, endoscopy is commonly perceived by patients as an invasive, uncomfortable, and often painful procedure. In addition, the anxiety and fear experienced before the procedure can lead to both physical and emotional distress, negatively affecting overall patient comfort and potentially intensifying the perception of pain.
Moderate to severe anxiety during endoscopy has been shown to increase the likelihood of procedural difficulties, prolong the duration of the examination, reduce patient satisfaction, and elevate the risk of complications. These adverse effects highlight the importance of implementing non-pharmacological strategies aimed at reducing anxiety and improving patient comfort. One such approach-guided visualization or visualized meditation-has gained attention as a simple, cost-effective, and patient-friendly method that promotes relaxation, reduces emotional tension, and supports pain management.
Considering the potential of guided visualization to enhance tolerance to the procedure and improve patient experiences, researchers were motivated to explore its effectiveness in this specific population. Therefore, this study was designed to determine the effect of visualized meditation applied to patients undergoing endoscopy on their levels of anxiety, pain, and comfort.
- Conditions
- Endoscopy, Pain, Comfort, Randomized Controlled Trial
- Being tested
- Visualized meditation
- Keywords
- Endoscopy, pain, comfort, visualized meditation, Endoscopy, Pain, Comfort, Visualized meditation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualized meditationOther
In the study, the experimental group will listen to visualized meditation sessions daily, morning and evening, for three days before the endoscopy. On the morning of the endoscopy, patients will be administered a personal information form, STAI1-2, pain scale, and comfort scale. After the procedure, the patients will be taken to the recovery area and will be administered the STAI1-2, pain scale, and comfort scale again.
| Study group | Role | What they receive |
|---|---|---|
| Visualized meditation group | Active comparator | Visualized meditation for patients who have had an endoscopy Receives: Other: Visualized meditation |
| Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Pain and Comfort Scale
This scale was developed by Price and colleagues (1983). It is used to measure subjective pain and comfort levels. The scale is represented by a 10-cm line representing the lowest and highest pain scores (0: no pain/discomfort, 10: most intolerable pain/discomfort).
Measured: From enrollment to the end of treatment at 4 months
The State Trait Anxiety Inventory (STAI)
The State Trait Anxiety Inventory (STAI), developed by Spielberger et al. in 1964, will be used to measure anxiety in this study. The scale has two dimensions: the STAI-S, which measures state anxiety, and the STAI-T, which measures trait anxiety. The STAI-S and STAI-T each consist of 20 items. Items 1-40 on the scale measure anxiety in four ways. The lowest score for both dimensions of the scale is 20, and the highest score is 80. As the score increases, the level of anxiety also increases.
Measured: "From enrollment to the end of treatment at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start14 Jul 2025
- Primary completion21 Oct 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Albayram, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261839
- Sponsor's protocol ID
- 2024/408
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not plan to share your IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visualized Meditation on Anxiety, Pain, and Comfort in Patients Undergoing Endoscopy
- ClinicalTrials.gov ID
- NCT07261839
- Acronym / sponsor ID
- 2024/408
- Conditions
- Endoscopy, Pain, Comfort, Randomized Controlled Trial
- Keywords
- Endoscopy, pain, comfort, visualized meditation, Endoscopy, Pain, Comfort, Visualized meditation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Dec 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.
Endoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of many diseases and plays a crucial role in the diagnosis and treatment of upper gastrointestinal disorders. Sometimes, endoscopy may be the only option for detecting certain diseases of the stomach and larynx. However, for many patients, endoscopy is considered an invasive, highly painful, and extremely uncomfortable procedure. Furthermore, anxiety and fear felt before the procedure can cause physical and emotional discomfort, disrupt patient comfort, and cause pain.
Detailed description
Endoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of various gastrointestinal disorders and plays a critical role, particularly in the evaluation of upper gastrointestinal system pathologies. In certain clinical situations, endoscopy may be the only reliable method for identifying diseases occurring in the stomach, esophagus, and larynx. Despite its diagnostic and therapeutic value, endoscopy is commonly perceived by patients as an invasive, uncomfortable, and often painful procedure. In addition, the anxiety and fear experienced before the procedure can lead to both physical and emotional distress, negatively affecting overall patient comfort and potentially intensifying the perception of pain.
Moderate to severe anxiety during endoscopy has been shown to increase the likelihood of procedural difficulties, prolong the duration of the examination, reduce patient satisfaction, and elevate the risk of complications. These adverse effects highlight the importance of implementing non-pharmacological strategies aimed at reducing anxiety and improving patient comfort. One such approach-guided visualization or visualized meditation-has gained attention as a simple, cost-effective, and patient-friendly method that promotes relaxation, reduces emotional tension, and supports pain management.
Considering the potential of guided visualization to enhance tolerance to the procedure and improve patient experiences, researchers were motivated to explore its effectiveness in this specific population. Therefore, this study was designed to determine the effect of visualized meditation applied to patients undergoing endoscopy on their levels of anxiety, pain, and comfort.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visualized meditation group | Active comparator | Other: Visualized meditationVisualized meditation for patients who have had an endoscopy |
| Control group | No intervention | –Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over the age of 18, with no hearing impairment,
- Students undergoing endoscopy for the first time,
- Not diagnosed with a psychiatric disorder and therefore not on medication,
- Willing to participate in the study
Key exclusion criteria (2 listed)
- Patients who refused to participate in the study, underwent endoscopy for biopsy, or received deep sedation.
- Patients who volunteered to participate and then wished to withdraw from the study at any stage.
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 |
|---|---|---|
| Visualized meditationIn the study, the experimental group will listen to visualized meditation sessions daily, morning and evening, for three days before the endoscopy. On the morning of the endoscopy, patients will be administered a personal information form, STAI1-2, pain scale, and comfort scale. After the procedure, the patients will be taken to the recovery area and will be administered the STAI1-2, pain scale, and comfort scale again. | Other | Visualized meditation group |
Primary outcome
VAS Pain and Comfort Scale
Time frame: From enrollment to the end of treatment at 4 months
This scale was developed by Price and colleagues (1983). It is used to measure subjective pain and comfort levels. The scale is represented by a 10-cm line representing the lowest and highest pain scores (0: no pain/discomfort, 10: most intolerable pain/discomfort).
The State Trait Anxiety Inventory (STAI)
Time frame: "From enrollment to the end of treatment at 4 months
The State Trait Anxiety Inventory (STAI), developed by Spielberger et al. in 1964, will be used to measure anxiety in this study. The scale has two dimensions: the STAI-S, which measures state anxiety, and the STAI-T, which measures trait anxiety. The STAI-S and STAI-T each consist of 20 items. Items 1-40 on the scale measure anxiety in four ways. The lowest score for both dimensions of the scale is 20, and the highest score is 80. As the score increases, the level of anxiety also increases.
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 3 Dec 2025.
- Individual participant dataSharing planned: No. I do not plan to share your IPD with other researchers.
Related trials for Endoscopy
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Recovery Time With the Application of ALDRETE Score in Patients Undergoing Gastrointestinal Endoscopy
Patients Undergoing Gastrointestinal Endoscopy
RecruitingObservational study
Safety of Sedation During Interventional Endoscopy
Sedation Complication, Sedation During GI Endoscopy
Recruiting
Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
Upper Endoscopy, GLP1-R-related Disease
Active, not recruiting
Box Breathing and Physiological Feedback Before Endoscopy
Breathing Exercises, Physiological Feedback
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visualized meditation in people with Endoscopy and Pain, run by University of Gaziantep 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 3 Dec 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Pain and Comfort Scale (time frame: From enrollment to the end of treatment at 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.