NCT07034638

Brief Summary

In recent years, there has been an increase in the use of endoscopic procedures due to the increase in diseases. Colonoscopy is widely used in the screening and diagnosis of many diseases, especially colorectal cancer. However, colonoscopy is perceived as an invasive, painful and uncomfortable procedure by patients. Moreover, it can cause pain associated with embarrassment, fear, anxiety and physical and emotional discomfort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 24, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

June 14, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

colonoscopywhite noisepink noisepainanxiety

Outcome Measures

Primary Outcomes (4)

  • Visual Anxiety Scale (VAS-A)

    VAS-A is a single-item measurement tool that has been used for psychological assessment since the beginning of the 20th century. It is frequently used in the assessment of pain, quality of life and mood. It was developed by "Cline et al" (1992) and is extremely simple, reproducible and requires minimal tools. The scale consists of a 10 cm long horizontal line with the labels "No anxiety" on the left and "I feel a lot of anxiety" on the right. The patient's anxiety level is calculated by measuring the distance between the leftmost part of the scale and the specified point. As the anxiety level approaches 10, anxiety increases.

    before colonoscopy 30 minutes

  • Visual Anxiety Scale (VAS-A)

    VAS-A is a single-item measurement tool that has been used for psychological assessment since the beginning of the 20th century. It is frequently used in the assessment of pain, quality of life and mood. It was developed by "Cline et al" (1992) and is extremely simple, reproducible and requires minimal tools. The scale consists of a 10 cm long horizontal line with the labels "No anxiety" on the left and "I feel a lot of anxiety" on the right. The patient's anxiety level is calculated by measuring the distance between the leftmost part of the scale and the specified point. As the anxiety level approaches 10, anxiety increases.

    before colonoscopy 10 minutes

  • The Visual Analog Scale (VAS)

    The Visual Analog Scale (VAS) is a single-dimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm). This measuring tool can be used horizontally or vertically. The scale starts with "no pain" and ends with "unbearable pain". High scores obtained from the scale indicate high pain intensity. The cut-off points for pain scores obtained from the scale are recommended as 0-4 mm "no pain", 5-44 mm "mild pain", 45-74 mm "moderate pain" and 75-100 mm "severe pain".

    before colonoscopy 30 minutes

  • The Visual Analog Scale (VAS)

    The Visual Analog Scale (VAS) is a single-dimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm). This measuring tool can be used horizontally or vertically. The scale starts with "no pain" and ends with "unbearable pain". High scores obtained from the scale indicate high pain intensity. The cut-off points for pain scores obtained from the scale are recommended as 0-4 mm "no pain", 5-44 mm "mild pain", 45-74 mm "moderate pain" and 75-100 mm "severe pain".

    before colonoscopy 10 minutes

Study Arms (3)

Control group

NO INTERVENTION

Patients in the control group will only be subject to the hospital's current standard care protocol. The procedures performed within the scope of this protocol include routine practices such as informing the patient, making the necessary medical preparations, and providing basic nursing interventions during the procedure. After the colonoscopy procedure is completed, the patient will be taken out of the endoscopy room and taken to the rest area where they will rest for 10 minutes in a quiet environment. At the end of this period, the VAS and VAS-A forms will be filled in again by the researcher and post-procedure pain and anxiety levels will be measured.

white noise

EXPERIMENTAL

In this group, patients will listen to white noise via headphones in addition to the hospital's standard care protocol prior to and during the colonoscopy procedure, as directed by the researcher. White noise is a type of sound that contains equal intensity sound across the entire frequency spectrum and suppresses environmental sounds that distract the individual by masking external noise. Patients will choose one of three compact discs containing white noise (babbling brook, distant thunderstorm, soothing rain; Pure White Noise, Windsor, CO). The patient will listen to the noise via headphones for 20 minutes before the colonoscopy begins. It will continue uninterrupted throughout the procedure, and pain will be assessed with VAS and anxiety levels will be assessed with VAS-A during the procedure. The sound level will be adjusted to predetermined safe levels so as not to disrupt the patient's comfort. After the colonoscopy procedure is completed, the patient will be taken out of the e

Behavioral: WNG

Pink noise

EXPERIMENTAL

In addition to the standard care protocol, the patients included in this group will listen to pink noise through headphones as directed by the researcher. Pink noise is a sound form that is dominated by low-frequency sounds and provides a more natural, soft acoustic environment. Sounds similar to sounds in nature (e.g. wind, rain, ocean waves) are included as pink noise. The patient will listen to pink noise through headphones for 20 minutes before the colonoscopy begins. It will continue uninterrupted throughout the procedure. During the procedure, pain will be assessed with VAS and anxiety levels will be assessed with VAS-A. The sound level will be adjusted to predetermined safe levels so as not to disrupt the patient's comfort. After the colonoscopy procedure is completed, the patient will be taken out of the endoscopy room and taken to the resting area where they will rest for 10 minutes in a quiet environment. At the end of this period, the researcher will fill in the VAS and VAS

Behavioral: PNG

Interventions

WNGBEHAVIORAL

In addition to the hospital's standard care protocol, patients in this group will listen to white noise through headphones before and during the colonoscopy procedure, as directed by the researcher.

white noise
PNGBEHAVIORAL

In addition to the standard care protocol, patients included in this group will listen to pink noise through headphones as directed by the researcher.

Pink noise

Eligibility Criteria

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

You may qualify if:

  • Volunteering to participate in the study,
  • Being over 18 years old,
  • Being able to speak and read and write Turkish,
  • The patient should not have a hearing problem,
  • Being conscious, oriented and cooperative

You may not qualify if:

  • The patient's use of anxiolytics or analgesics on the day of the procedure,
  • The patient's diagnosis of any psychiatric / neurological disease,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seda Cansu Yeniğün

Antalya, Kumluca, 07350, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Dr

Study Record Dates

First Submitted

June 14, 2025

First Posted

June 24, 2025

Study Start

June 24, 2025

Primary Completion

October 18, 2025

Study Completion

November 1, 2025

Last Updated

December 1, 2025

Record last verified: 2025-11

Locations