- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07261839
Effect of Visualized Meditation on Anxiety, Pain, and Comfort in Patients Undergoing Endoscopy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Turkey (Türkiye), 27310
- Gaziantep University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Active Comparator: Visualized meditation group
Visualized meditation for patients who have had an endoscopy
|
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.
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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