Surgical Procedures, ElectiveColonoscopyNCT07034638
Effects of White and Pink Noise Applied Before and During Colonoscopy on Pain and Anxiety
A study testing WNG and PNG in people with Surgical Procedures, Elective and Nurse Based Care Management, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedures, Elective, Nurse Based Care Management
- What is being tested?
- WNG and PNG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2025to 18 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The patient's use of anxiolytics or analgesics on the day of the procedure,
- The patient's diagnosis of any psychiatric / neurological disease,
- The patient's preference for general anesthesia will be considered as exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, 34098
About this study
Official title: Effects of White and Pink Noise Applied Before and During Colonoscopy on Pain and Anxiety: A Randomized Controlled Trial
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.
Read the detailed description
This study aims to evaluate the effects of white and pink noise applied before and during colonoscopy on pain and anxiety levels of patients. Colonoscopy is a widely used method in colon cancer screening and diagnosis and treatment of lower gastrointestinal system diseases; however, pain may occur in patients due to mesenteric distension and spasms during the procedure. In addition, many patients experience moderate anxiety during the procedure. Since pharmacological pain and anxiety management strategies may lead to some complications, in recent years, there has been an increase in the use of non-pharmacological methods such as music, video, virtual reality and distraction techniques. One of these methods, sound therapy, provides relaxation by directing the individual's attention to positive emotions. While white noise is a constant-intensity sound similar to the sound of the ocean or wind, pink noise resembles rain or rustling leaves with its lower frequency and soothing properties. There are a limited number of studies in the literature examining the effects of white and pink noise, but there is no study evaluating both types of noise together in colonoscopy patients. In order to fill this gap, the effects of white and pink noise on pain and anxiety are comparatively examined in this study.
- Being tested
- WNG, PNG
- Keywords
- colonoscopy, white noise, pink noise, pain, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WNGBehavioural
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.
PNGBehavioural
In addition to the standard care protocol, patients included in this group will listen to pink noise through headphones as directed by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PNG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: During colonoscopy, immediately after the 20-minute auditory intervention, and 30 minutes after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start24 Jun 2025
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedures, ElectiveStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansu Yeniğün, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034638
- Sponsor's protocol ID
- Scy120991
- Acronym
- Colonoscopy
- Status last verified
- Nov 2025
- First submitted
- 14 Jun 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Toprak C, Akbulut SCY, Kurtulus N, Cavdar I. Effects of white and pink noise administered before and during colonoscopy on pain and anxiety: a randomized controlled trial. Surg Endosc. 2026 Aug 20. doi: 10.1007/s00464-026-13165-x. Online ahead of print.
PubMed 42625068
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of White and Pink Noise Applied Before and During Colonoscopy on Pain and Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07034638
- Acronym / sponsor ID
- Colonoscopy / Scy120991
- Keywords
- colonoscopy, white noise, pink noise, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to evaluate the effects of white and pink noise applied before and during colonoscopy on pain and anxiety levels of patients. Colonoscopy is a widely used method in colon cancer screening and diagnosis and treatment of lower gastrointestinal system diseases; however, pain may occur in patients due to mesenteric distension and spasms during the procedure. In addition, many patients experience moderate anxiety during the procedure. Since pharmacological pain and anxiety management strategies may lead to some complications, in recent years, there has been an increase in the use of non-pharmacological methods such as music, video, virtual reality and distraction techniques. One of these methods, sound therapy, provides relaxation by directing the individual's attention to positive emotions. While white noise is a constant-intensity sound similar to the sound of the ocean or wind, pink noise resembles rain or rustling leaves with its lower frequency and soothing properties. There are a limited number of studies in the literature examining the effects of white and pink noise, but there is no study evaluating both types of noise together in colonoscopy patients. In order to fill this gap, the effects of white and pink noise on pain and anxiety are comparatively examined in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: WNGIn 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. |
| Pink noise | Experimental | Behavioral: PNGIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteering to participate in the study,
Key exclusion criteria (3 listed)
- The patient's use of anxiolytics or analgesics on the day of the procedure,
- The patient's diagnosis of any psychiatric / neurological disease,
- The patient's preference for general anesthesia will be considered as exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WNGIn 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. | Behavioural | white noise |
| PNGIn addition to the standard care protocol, patients included in this group will listen to pink noise through headphones as directed by the researcher. | Behavioural | Pink noise |
Primary outcome
Visual Anxiety Scale (VAS-A)
Time frame: Before colonoscopy (baseline), during colonoscopy immediately after the 20-minute auditory intervention, and 30 minutes after colonoscopy
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.
The Visual Analog Scale (VAS)
Time frame: During colonoscopy, immediately after the 20-minute auditory intervention, and 30 minutes after colonoscopy
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 42625068Toprak C, Akbulut SCY, Kurtulus N, Cavdar I. Effects of white and pink noise administered before and during colonoscopy on pain and anxiety: a randomized controlled trial. Surg Endosc. 2026 Aug 20. doi: 10.1007/s00464-026-13165-x. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WNG and PNG in people with Surgical Procedures, Elective and Nurse Based Care Management, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Anxiety Scale (VAS-A) (time frame: Before colonoscopy (baseline), during colonoscopy immediately after the 20-minute auditory intervention, and 30 minutes after colonoscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07034638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.