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

NCT07261839 | Enrolling By Invitation DMC

• 1 other identifier: 2024/408
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endoscopy; Comfort; Randomized Controlled Trial; Pain

Keywords

Endoscopy, pain, comfort, visualized meditation; Endoscopy; Pain; Comfort; Visualized meditation

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  "From enrollment to the end of treatment at 4 months

Study Arms (2)

Visualized meditation group

ACTIVE COMPARATOR

Visualized meditation for patients who have had an endoscopy

Other: Visualized meditation

Control group

NO INTERVENTION

Control group

Interventions

Visualized meditation OTHER

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.

Visualized meditation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Dr

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: December 3, 2025
• Study Start: July 14, 2025
• Primary Completion: October 21, 2025
• Study Completion: December 31, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)