NCT07255417

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

November 15, 2025

Last Update Submit

November 28, 2025

Conditions

Keywords

ColonoscopyVisualized meditationPainComfortRandomized controlled trial

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

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.

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.

Interventions

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.

Visualized meditation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaPain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
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 1, 2025

Study Start

March 4, 2025

Primary Completion

October 27, 2025

Study Completion

October 28, 2025

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations