An interventional study of Music intervention and white noise intervention in School Age Children and Endoscopy, Gastrointestinal, sponsored by Istanbul University - Cerrahpasa. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Supportive care
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.
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.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's planned enrollment of 102 is above the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Istanbul University - Cerrahpasa is the lead sponsor of 693 studies on the registry; 213 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children in the group will be made to listen to white noise at an appropriate decibel level.
Behavioral: white noise intervention
Music will be listened at an appropriate decibel level for the children in the group.
Behavioral: Music intervention
No application was made to the control group.
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 will be played at a decibel level appropriate for the children in the group.
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).
Time frame: 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.
Time frame: 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.
Time frame: six months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: six months
Plan to share: No — I think it is not appropriate to share all information in terms of patient privacy.
No publications or documents are linked to this record.
Ran from Sep 2023 to primary completion in Sep 2024, 12 months.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 12 months is close to that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istanbul University - Cerrahpasa →