- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07255417
The Effect of Visualized Meditation on Anxiety, Pain, and Comfort in Patients Undergoing Colonoscopy
November 28, 2025 updated by: Tuğba Albayram, University of Gaziantep
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Turkey (Türkiye), 27310
- Gaziantep University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Visualized meditation group
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.
|
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.
|
|
No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
From enrollment to the end of treatment at 4 months
|
|
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.
|
From enrollment to the end of treatment at 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2025
Primary Completion (Actual)
October 27, 2025
Study Completion (Actual)
October 28, 2025
Study Registration Dates
First Submitted
November 15, 2025
First Submitted That Met QC Criteria
November 19, 2025
First Posted (Estimated)
December 1, 2025
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
November 28, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/489
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is not a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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