Effects of White and Pink Noise Applied Before and During Colonoscopy on Pain and Anxiety

NCT07034638 | Completed DMC

• 1 other identifier: Scy120991
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Procedures, Elective; Nurse Based Care Management

Keywords

colonoscopy; white noise; pink noise; pain; anxiety

Outcome Measures

Primary Outcomes (2)

• 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 (baseline), during colonoscopy immediately after the 20-minute auditory intervention, and 30 minutes after colonoscopy

• 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".

  During colonoscopy, immediately after the 20-minute auditory intervention, and 30 minutes after colonoscopy

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 30 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. The patient will listen to the noise via headphones for 20 minutes before the colonoscopy begins. It will be administered for 20 minutes during 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. At the end of the 30-minute observation period, pain and anxiety levels will be reassessed using the VAS and VAS-A.

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 be administered for 20 minutes during 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 maintained at a safe level. After the colonoscopy, patient will be transferred to the observation area and rest for 30 minutes.

Behavioral: PNG

Interventions

WNG BEHAVIORAL

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

PNG BEHAVIORAL

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the study,
• Being over 18 years old,
• The patient should not have a hearing and visual 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,

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistical analysis was performed by an independent statistician who was blinded to group allocation.
• 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: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: August 18, 2026

Record last verified: 2025-11

Locations

TU (1)