School Age ChildrenNCT06699745
Comparison of the Effects of Music and White Noise in Children Performed Endoscopy
A study testing Music intervention and white noise intervention in people with School Age Children and Endoscopy, Gastrointestinal, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The study was planned as a randomized controlled experimental study to compare the effects of music and white noise on fear, anxiety and pain levels before, during and after the procedure in school-age children (6-12 years old) who will undergo endoscopy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- School Age Children, Endoscopy, Gastrointestinal
- What is being tested?
- Music intervention and white noise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- School age (6-12 years old) child,
- Have not had an endoscopy procedure before,
- Have not had a surgical procedure before,
- Have been requested to have an endoscopy by a physician,
- Be able to communicate,
- Have no hearing or speech problems,
Show all 10Show fewer
- Agree to participate in the study,
- Have not used analgesics for 6 hours before the procedure,
- The child can count from 1 to 10,
- Have the ability to order numbers (knowing that numbers are big or small (e.g. 6 is less than 7, 4 is greater than 2, etc.).
Who cannot join
- Not being of school age (under 6 years old, over 12 years old),
- Having had an endoscopy procedure before,
- Having had a surgical procedure before,
- Not being able to communicate,
- Having hearing and speech problems,
- Not agreeing to participate in the study,
- Having used analgesics up to 6 hours before the procedure,
- The child not having the ability to sort and count numbers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Avcilar, 34320
About this study
Official title: Comparison of the Effects of Music and White Noise on Fear, Anxiety and Pain Levels in Children Performed Endoscopy
The study was planned as a randomized controlled experimental study to compare the effects of music and white noise on fear, anxiety and pain levels before, during and after the procedure in school-age children (6-12 years old) who will undergo endoscopy.
Hypothesis 0 (H0): There is no difference in fear, anxiety, pain, parental anxiety and pulse, respiration and oxygen saturation values between children exposed to music and white noise.
Read more
Hypothesis 1 (H1): Children who were exposed to music and white noise had lower fear scores than children who were not exposed to any application.
Hypothesis 2 (H2): Children who were exposed to music and white noise had lower anxiety scores than children who were not exposed to any application.
Hypothesis 3 (H3): Children who were exposed to music and white noise had lower pain scores than children who were not exposed to any application.
Hypothesis 4 (H4): Children who were exposed to music and white noise had lower pulse value scores than children who were not exposed to any application.
Hypothesis 5 (H5): Children who were exposed to music and white noise had lower respiratory rate scores than children who were not exposed to any application.
Hypothesis 6 (H6): Children who were exposed to music and white noise had higher oxygen saturation value scores than children who were not exposed to any application.
Hypothesis 7 (H7): Parents of children who were exposed to music and white noise had lower parental anxiety than parents of children who were not exposed to any treatment.
There are music group, white noise and control group in the study.
Read the detailed description
The independent variables of the study are age, gender, music and white noise application.
The dependent variables are; Children's Fear Scale (CFS) scores used to measure children's fear, Children's Anxiety Scale-State (CAS-D) scores used to measure anxiety, The Faces Pain Scale Revised (FPS-R) scores used to measure pain status, pulse, respiratory rate and oxygen saturation values and Beck Anxiety Inventory scores obtained from parents.
- Conditions
- School Age Children, Endoscopy, Gastrointestinal
- Being tested
- Music intervention, white noise intervention
- Keywords
- endoscopy, fear, anxiety, pain, music, white noise
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
In studies, white noise was used as a sedative in infants. It was not used in older children. In school-age children, white noise will be used to reduce fear, anxiety and pain during the endoscopy procedure.
white noise interventionBehavioural
White noise will be played at a decibel level appropriate for the children in the group.
| Study group | Role | What they receive |
|---|---|---|
| white noise group | Experimental | Children in the group will be made to listen to white noise at an appropriate decibel level. Receives: Behavioral: white noise intervention |
| music group | Experimental | Music will be listened at an appropriate decibel level for the children in the group. Receives: Behavioral: Music intervention |
| control group | No intervention | No application was made to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child fear scale
The Child Fear Scale (CFS), developed by McMurty and colleagues (2011), consists of five drawn facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). The validity and reliability of the scale were performed by Gerçeker and colleagues (2018). The CGI value for the CFS is 0.89 (McMurty et al., 2011).
Measured: six months
Child anxiety scale-state
The Child Anxiety Scale State (CAS-S) developed by Ersig et al. (2013) is used to measure the anxiety of the child's current situation. The validity and reliability of the scale were made by Gerceker et al. (2018). The Content Validity Index (CVI) value for CAS-S was found to be 1.00.
Measured: six months
The Faces Pain Scale - Revised
It is a self-report measure of pain intensity developed for children. It has been made more suitable for use by using visual depictions of six facial expressions representing increasing levels of pain intensity and by adapting the metric scoring to 0-10. The revised version of the facial pain scale is widely used in the adult and pediatric populations for pain intensity assessment. It is easy to apply and does not require any equipment other than the faces in the picture.
Measured: six months
Secondary outcomes (4)
Beck Anxiety Inventory
Developed by Beck et al. (1988). The Cronbach alpha coefficient of the original scale is .93. The Turkish adaptation of the Beck Anxiety Inventory was prepared by Ulusoy et al. (1998). In the Turkish validity and reliability study of the scale, Cronbach alpha coefficient was determined as .93. The Beck Anxiety Inventory is a 21-question scale that individuals can answer on their own. Questions are scored between 0 and 3. The minimum score is 0 and the maximum score is 63. The total score is used in the evaluation of the scale. Increasing scores on the scale indicate an increase in the anxiety level.
Measured: six months
pulse value
In the study, the child's pulse value was measured from the calibrated monitor before, during and after the endoscopy procedure.
Measured: six months
respiratory value
In the study, the child's respiratory value was measured from the calibrated monitor before, during and after the endoscopy procedure.
Measured: six months
oxygen saturation value
In the study, the child's respiratory value was measured from the calibrated monitor before, during and after the endoscopy procedure.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start15 Sep 2023
- Primary completion15 Sep 2024
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School Age ChildrenStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Inac Yilmaz, Istanbul University - Cerrahpasa
- Investigators
- Busra Inac Yilmaz, MD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699745
- Sponsor's protocol ID
- IUC-LEE-BIY-26
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I think it is not appropriate to share all information in terms of patient privacy.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Music and White Noise on Fear, Anxiety and Pain Levels in Children Performed Endoscopy
- ClinicalTrials.gov ID
- NCT06699745
- Acronym / sponsor ID
- IUC-LEE-BIY-26
- Conditions
- School Age Children, Endoscopy, Gastrointestinal
- Keywords
- endoscopy, fear, anxiety, pain, music, white noise
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 21 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 study was planned as a randomized controlled experimental study to compare the effects of music and white noise on fear, anxiety and pain levels before, during and after the procedure in school-age children (6-12 years old) who will undergo endoscopy.
Hypothesis 0 (H0): There is no difference in fear, anxiety, pain, parental anxiety and pulse, respiration and oxygen saturation values between children exposed to music and white noise.
Hypothesis 1 (H1): Children who were exposed to music and white noise had lower fear scores than children who were not exposed to any application.
Hypothesis 2 (H2): Children who were exposed to music and white noise had lower anxiety scores than children who were not exposed to any application.
Hypothesis 3 (H3): Children who were exposed to music and white noise had lower pain scores than children who were not exposed to any application.
Hypothesis 4 (H4): Children who were exposed to music and white noise had lower pulse value scores than children who were not exposed to any application.
Hypothesis 5 (H5): Children who were exposed to music and white noise had lower respiratory rate scores than children who were not exposed to any application.
Hypothesis 6 (H6): Children who were exposed to music and white noise had higher oxygen saturation value scores than children who were not exposed to any application.
Hypothesis 7 (H7): Parents of children who were exposed to music and white noise had lower parental anxiety than parents of children who were not exposed to any treatment.
There are music group, white noise and control group in the study.
Detailed description
The independent variables of the study are age, gender, music and white noise application.
The dependent variables are; Children's Fear Scale (CFS) scores used to measure children's fear, Children's Anxiety Scale-State (CAS-D) scores used to measure anxiety, The Faces Pain Scale Revised (FPS-R) scores used to measure pain status, pulse, respiratory rate and oxygen saturation values and Beck Anxiety Inventory scores obtained from parents.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| white noise group | Experimental | Behavioral: white noise interventionChildren in the group will be made to listen to white noise at an appropriate decibel level. |
| music group | Experimental | Behavioral: Music interventionMusic will be listened at an appropriate decibel level for the children in the group. |
| control group | No intervention | –No application was made to the control group. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- School age (6-12 years old) child,
- Have not had an endoscopy procedure before,
- Have not had a surgical procedure before,
- Have been requested to have an endoscopy by a physician,
- Be able to communicate,
Key exclusion criteria (8 listed)
- Not being of school age (under 6 years old, over 12 years old),
- Having had an endoscopy procedure before,
- Having had a surgical procedure before,
- Not being able to communicate,
- Having hearing and speech problems,
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 interventionIn studies, white noise was used as a sedative in infants. It was not used in older children. In school-age children, white noise will be used to reduce fear, anxiety and pain during the endoscopy procedure. | Behavioural | music group |
| white noise interventionWhite noise will be played at a decibel level appropriate for the children in the group. | Behavioural | white noise group |
Primary outcome
Child fear scale
Time frame: six months
The Child Fear Scale (CFS), developed by McMurty and colleagues (2011), consists of five drawn facial expressions ranging from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). The validity and reliability of the scale were performed by Gerçeker and colleagues (2018). The CGI value for the CFS is 0.89 (McMurty et al., 2011).
Child anxiety scale-state
Time frame: six months
The Child Anxiety Scale State (CAS-S) developed by Ersig et al. (2013) is used to measure the anxiety of the child's current situation. The validity and reliability of the scale were made by Gerceker et al. (2018). The Content Validity Index (CVI) value for CAS-S was found to be 1.00.
The Faces Pain Scale - Revised
Time frame: six months
It is a self-report measure of pain intensity developed for children. It has been made more suitable for use by using visual depictions of six facial expressions representing increasing levels of pain intensity and by adapting the metric scoring to 0-10. The revised version of the facial pain scale is widely used in the adult and pediatric populations for pain intensity assessment. It is easy to apply and does not require any equipment other than the faces in the picture.
4 secondary outcomes
Beck Anxiety Inventory
Time frame: six months
pulse value
Time frame: six months
respiratory value
Time frame: six months
oxygen saturation value
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No. I think it is not appropriate to share all information in terms of patient privacy.
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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.
Busra Inac Yilmaz, MD principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention and white noise intervention in people with School Age Children and Endoscopy, Gastrointestinal, run by Istanbul University - Cerrahpasa 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 10 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 21 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Child fear scale (time frame: six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.