ColonoscopyNCT06669338
Effects of Music Therapy and White Noise on Pre-procedural Fear, Anxiety by Elderly Colonoscopy Patients
A study testing Music therapy, listen to white noise and listen to hospital ambient sound in people with Colonoscopy and the Elderly, run by Muğla Sıtkı Koçman University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of the study was to examine the effect of two different interventions (music therapy and white noise listening) on anxiety, fear and vital signs in elderly patients undergoing colonoscopy. The study was a double-blind, pre-test and post-test Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colonoscopy, the Elderly, White Noise
- What is being tested?
- Music therapy, listen to white noise and listen to hospital ambient sound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Oct 2024to 25 Nov 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The one to be colonoscoped,
- 65 years of age or older,
- Participated in the research voluntarily
- No vision, hearing and perception problems,
- No communication problems (able to speak Turkish),
- Those who are hemodynamically stable before colonoscopy,
- No psychiatric diagnosis, no use of antidepressants, anxiolytics and sedative agents,
- No analgesic or anesthetic medication 24 hours before the procedure.
Who cannot join
- Developing complications during the procedure,
- Removing the headset during the procedure,
- Participants with visual and hearing impairment or a medical history of dementia, cognitive impairments or psychiatric disorders
- The general condition deteriorated during the procedure or a different intervention was performed with anesthesia,
- Who wants to leave the study on their own accord.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Mugla
Muğla, Mentese, 48000
Mugla
Muğla, 48000
About this study
Official title: The Effect of Music Therapy and White Noise on Pre-procedural Fear, Anxiety and Vital Signs of Elderly Colonoscopy Patients: A Double-Blind Randomized Controlled Trial
The aim of the study was to examine the effect of two different interventions (music therapy and white noise listening) on anxiety, fear and vital signs in elderly patients undergoing colonoscopy.
The study was a double-blind, pre-test and post-test
Read the detailed description
Colonoscopy patients experience high levels of fear and anxiety due to the procedure. Fear and anxiety can activate the patient's autonomic nervous system, leading to increased sweating, increased heart rate, blood pressure and respiratory rate, and procedure-related complications. Reducing fear and anxiety and relaxing the patient not only prevents potential harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. In this context, this study aimed to investigate the effects of music therapy and white noise listening on the fear, anxiety and vital signs of patients undergoing colonoscopy.
- Conditions
- Colonoscopy, the Elderly, White Noise, Music Therapy, Fear, Anxiety
- Being tested
- Music therapy, listen to white noise, listen to hospital ambient sound
- Keywords
- Colonoscopy;anxiety;fear;vital signs;musictherapy;whitenoise
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
patients listen to music for 20 minutes with headphones before colonoscopy.
listen to white noiseOther
patients listen to white noise with headphones for 20 minutes before colonoscopy.
listen to hospital ambient soundOther
patients listen to recorded ambient sound for 20 minutes with headphones before colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| music therapy group | Experimental | The group that listened to music for 20 minutes before the colonoscopy Receives: Other: Music therapy |
| white noise group | Experimental | The group that listened to white noise for 20 minutes before the colonoscopy Receives: Other: listen to white noise |
| control group | Placebo comparator | The group that listened to recorded ambient sound for 20 minutes before the colonoscopy. Receives: Other: listen to hospital ambient sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory rate
Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.
Measured: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
Secondary outcomes (6)
diastolic blood pressure
Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.
Measured: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
Visual Analog Scale (VAS)
Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.
Measured: 20 minutes of music therapy, white noise and ambient sound before a colonoscopy.
The State-Trait Anxiety Inventory (STAI-I)
The scale is administered before colonoscopy, at the beginning and at the end of the music therapy, white noise and ambient sound listening intervention.
Measured: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
heart rate
Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.
Measured: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
SpO2: peripheral oxygen saturation (%)
Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.
Measured: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
systolic blood pressure
Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.
Measured: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start25 Oct 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
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 ColonoscopyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental study with three groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Cullu, Muğla Sıtkı Koçman University
- Investigators
- Mehtap ÇULLU, PhD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669338
- Sponsor's protocol ID
- MuglaSKU-HEM-MC-01
- Status last verified
- Nov 2024
- First submitted
- 29 Oct 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Taking time to share data and not having the time to do so, There is no benefit in sharing data,
Publications
Cullu M, Parlak AG, Ozkaraca Z. The Effect of Music Therapy and White Noise on Pre-Prosedural Fear, Anxiety, and Vital Signs of Elderly Colonoscopy Patients: A Double-Blind Randomized Controlled Trial. J Perianesth Nurs. 2026 Jul 14:S1089-9472(26)00378-3. doi: 10.1016/j.jopan.2026.06.010. Online ahead of print.
PubMed 42455089
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy and White Noise on Pre-procedural Fear, Anxiety and Vital Signs of Elderly Colonoscopy Patients: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06669338
- Acronym / sponsor ID
- MuglaSKU-HEM-MC-01
- Conditions
- Colonoscopy, the Elderly, White Noise, Music Therapy, Fear, Anxiety
- Keywords
- Colonoscopy;anxiety;fear;vital signs;musictherapy;whitenoise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 1 Nov 2024 (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.
The aim of the study was to examine the effect of two different interventions (music therapy and white noise listening) on anxiety, fear and vital signs in elderly patients undergoing colonoscopy.
The study was a double-blind, pre-test and post-test
Detailed description
Colonoscopy patients experience high levels of fear and anxiety due to the procedure. Fear and anxiety can activate the patient's autonomic nervous system, leading to increased sweating, increased heart rate, blood pressure and respiratory rate, and procedure-related complications. Reducing fear and anxiety and relaxing the patient not only prevents potential harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. In this context, this study aimed to investigate the effects of music therapy and white noise listening on the fear, anxiety and vital signs of patients undergoing colonoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- experimental study with three groups.
| Arm | Type | Receives |
|---|---|---|
| music therapy group | Experimental | Other: Music therapyThe group that listened to music for 20 minutes before the colonoscopy |
| white noise group | Experimental | Other: listen to white noiseThe group that listened to white noise for 20 minutes before the colonoscopy |
| control group | Placebo comparator | Other: listen to hospital ambient soundThe group that listened to recorded ambient sound for 20 minutes before the colonoscopy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- The one to be colonoscoped,
- 65 years of age or older,
- Participated in the research voluntarily
- No vision, hearing and perception problems,
- No communication problems (able to speak Turkish),
Key exclusion criteria (5 listed)
- Developing complications during the procedure,
- Removing the headset during the procedure,
- Participants with visual and hearing impairment or a medical history of dementia, cognitive impairments or psychiatric disorders
- The general condition deteriorated during the procedure or a different intervention was performed with anesthesia,
- Who wants to leave the study on their own accord.
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 |
|---|---|---|
| Music therapypatients listen to music for 20 minutes with headphones before colonoscopy. | Other | music therapy group |
| listen to white noisepatients listen to white noise with headphones for 20 minutes before colonoscopy. | Other | white noise group |
| listen to hospital ambient soundpatients listen to recorded ambient sound for 20 minutes with headphones before colonoscopy. | Other | control group |
Primary outcome
respiratory rate
Time frame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.
6 secondary outcomes
diastolic blood pressure
Time frame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
Visual Analog Scale (VAS)
Time frame: 20 minutes of music therapy, white noise and ambient sound before a colonoscopy.
The State-Trait Anxiety Inventory (STAI-I)
Time frame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
heart rate
Time frame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
SpO2: peripheral oxygen saturation (%)
Time frame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
systolic blood pressure
Time frame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.
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 19 Dec 2024.
- Derived from this study: PubMed 42455089Cullu M, Parlak AG, Ozkaraca Z. The Effect of Music Therapy and White Noise on Pre-Prosedural Fear, Anxiety, and Vital Signs of Elderly Colonoscopy Patients: A Double-Blind Randomized Controlled Trial. J Perianesth Nurs. 2026 Jul 14:S1089-9472(26)00378-3. doi: 10.1016/j.jopan.2026.06.010. Online ahead of print.
- Individual participant dataSharing planned: No. Taking time to share data and not having the time to do so, There is no benefit in sharing data,
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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.
Mehtap ÇULLU, PhD principal investigator
Muğla Sıtkı Koçman University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy, listen to white noise and listen to hospital ambient sound in people with Colonoscopy and the Elderly, run by Muğla Sıtkı Koçman University at 2 sites 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 8 inclusion and 5 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 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
respiratory rate (time frame: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.). 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 NCT06669338, 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 19 Dec 2024.