Effects of White and Pink Noise Applied Before and During Colonoscopy on Pain and Anxiety
Colonoscopy
1 other identifier
interventional
135
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 14, 2025
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedStudy Start
First participant enrolled
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedDecember 1, 2025
November 1, 2025
4 months
June 14, 2025
November 26, 2025
Conditions
Keywords
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 INTERVENTIONPatients 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
EXPERIMENTALIn 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
Pink noise
EXPERIMENTALIn 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
Interventions
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.
In addition to the standard care protocol, patients included in this group will listen to pink noise through headphones as directed by the researcher.
Eligibility Criteria
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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