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Enrolling by invitation NCT07261839

Effect of Visualized Meditation on Anxiety, Pain, and Comfort in Patients Undergoing Endoscopy

No phase Interventional Endoscopy Pain Comfort Randomized Controlled Trial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visualized meditation.
Who it may be relevant to
Registry conditions: Endoscopy, Pain, Comfort, Randomized Controlled Trial. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Visualized meditation
    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.

Primary outcome measures

  • VAS Pain and Comfort Scale [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Gaziantep University — Gaziantep

Identifiers

NCT: NCT07261839 · 2024/408

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗