ColonoscopyNCT07255417
The Effect of Visualized Meditation on Anxiety, Pain, and Comfort in Patients Undergoing Colonoscopy
A study testing Visualized meditation group in people with Colonoscopy and Pain Management, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Colonoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of intestinal diseases and plays a crucial role in the diagnosis and treatment of lower gastrointestinal disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Pain Management, Comfort
- What is being tested?
- Visualized meditation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2025to 28 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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,
- Submitting a colonoscopy for the first time,
- Not diagnosed with a psychiatric disorder and therefore not taking medication,
- Willing to participate in the study
Who cannot join
- Patients who refused to participate in the study, underwent a colonoscopy for biopsy, or underwent 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.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Şehitkamil, 27310
About this study
Colonoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of intestinal diseases and plays a crucial role in the diagnosis and treatment of lower gastrointestinal disorders. However, for many patients, colonoscopy is considered an invasive, highly painful, and extremely uncomfortable procedure. Furthermore, the anxiety and fear felt before the procedure can affect patients in many ways. These negative feelings can disrupt patient comfort and cause the pain to become even more severe.
Read the detailed description
Meditation and visualization exercises have been found to alter an individual's mood and perception. Recent neuroscience literature suggests that meditation practices alter brain chemistry, structure, and function more permanently. Meditation facilitates increased selective attention, which increases the ability to silence unwanted outcomes while focusing on a specific outcome, and reduces activity in the amygdala, which is associated with the production of fear and anxiety. Guided meditation with background music is effective in increasing attention, reducing stress, and therefore improving mental health. Visualization is the conscious control of mental imagery. Imagery often plays a fundamental role not only in experiencing reality but also in creating it. In this context, it can be argued that visualized meditation may also allow for the reshaping of perceived reality, such as anxiety and pain, and reduce their negative effects on the patient. This study was conducted to determine the effects of visualized meditation on anxiety, pain, and comfort in patients undergoing colonoscopy.
- Conditions
- Colonoscopy, Pain Management, Comfort, Randomised Controlled Trial
- Being tested
- Visualized meditation group
- Keywords
- Colonoscopy, Visualized meditation, Pain, Comfort, Randomized controlled trial
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualized meditation groupOther
In the study, the experimental group will listen to visualized meditation sessions daily, morning and evening, for three days before the colonoscopy. On the morning of the colonoscopy, 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 | In the study, the experimental group will listen to visualized meditation sessions daily, morning and evening, for three days before the colonoscopy. On the morning of the colonoscopy, 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. Receives: Other: Visualized meditation group |
| Control group | No intervention | In the study, the control group will be administered a personal information form, STAI1-2, pain scale, and comfort scale on the morning of the colonoscopy. After the procedure, the patients will be taken to the recovery area and the STAI1-2, pain scale, and comfort scale will be administered again. The control group will receive standard clinical care procedures. |
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 posted1 Dec 2025
- Study start4 Mar 2025
- Primary completion27 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
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
- NCT07255417
- Sponsor's protocol ID
- 2024/489
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visualized Meditation on Anxiety, Pain, and Comfort in Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT07255417
- Acronym / sponsor ID
- 2024/489
- Conditions
- Colonoscopy, Pain Management, Comfort, Randomised Controlled Trial
- Keywords
- Colonoscopy, Visualized meditation, Pain, Comfort, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 1 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.
Colonoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of intestinal diseases and plays a crucial role in the diagnosis and treatment of lower gastrointestinal disorders. However, for many patients, colonoscopy is considered an invasive, highly painful, and extremely uncomfortable procedure. Furthermore, the anxiety and fear felt before the procedure can affect patients in many ways. These negative feelings can disrupt patient comfort and cause the pain to become even more severe.
Detailed description
Meditation and visualization exercises have been found to alter an individual's mood and perception. Recent neuroscience literature suggests that meditation practices alter brain chemistry, structure, and function more permanently. Meditation facilitates increased selective attention, which increases the ability to silence unwanted outcomes while focusing on a specific outcome, and reduces activity in the amygdala, which is associated with the production of fear and anxiety. Guided meditation with background music is effective in increasing attention, reducing stress, and therefore improving mental health. Visualization is the conscious control of mental imagery. Imagery often plays a fundamental role not only in experiencing reality but also in creating it. In this context, it can be argued that visualized meditation may also allow for the reshaping of perceived reality, such as anxiety and pain, and reduce their negative effects on the patient. This study was conducted to determine the effects of visualized meditation on anxiety, pain, and comfort in patients undergoing colonoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visualized meditation group | Active comparator | Other: Visualized meditation groupIn the study, the experimental group will listen to visualized meditation sessions daily, morning and evening, for three days before the colonoscopy. On the morning of the colonoscopy, 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. |
| Control group | No intervention | –In the study, the control group will be administered a personal information form, STAI1-2, pain scale, and comfort scale on the morning of the colonoscopy. After the procedure, the patients will be taken to the recovery area and the STAI1-2, pain scale, and comfort scale will be administered again. The control group will receive standard clinical care procedures. |
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,
- Submitting a colonoscopy for the first time,
- Not diagnosed with a psychiatric disorder and therefore not taking medication,
- Willing to participate in the study
Key exclusion criteria (2 listed)
- Patients who refused to participate in the study, underwent a colonoscopy for biopsy, or underwent 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 meditation groupIn the study, the experimental group will listen to visualized meditation sessions daily, morning and evening, for three days before the colonoscopy. On the morning of the colonoscopy, 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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. This study is not recruiting at the moment.
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 group in people with Colonoscopy and Pain Management, 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: finished, as of the sponsor's last update on 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 5 Dec 2025.