Nurse's RoleNCT06424587
The Effect of Music Intervention on Anxiety, Fear, and Pain in Pediatric Patients Receiving Intrathecal Chemotherapy
A study testing Music intervention in people with Nurse's Role, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Intrathecal chemotherapy is often used to prevent the spread of cancer to the central nervous system in pediatric patients and is one of the most invasive procedures. It is believed that the way it is administered and the complications experienced after treatment negatively affect the comfort of the pediatric patient… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Dec 2023
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- To be between 6-12 years old,
- Being treated in the Hematology and Oncology Clinic,
- About to receive intrathecal chemotherapy treatment,
- The child not having pain before intrathecal chemotherapy treatment
Who cannot join
- Refusing to participate in the study,
- Being under 6 years of age and over 10 years of age,
- The child having pain prior to intrathecal chemotherapy treatment,
- Having any physical or mental disability,
- Not being able to speak Turkish.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Black Sea, 55100
About this study
Intrathecal chemotherapy is often used to prevent the spread of cancer to the central nervous system in pediatric patients and is one of the most invasive procedures. It is believed that the way it is administered and the complications experienced after treatment negatively affect the comfort of the pediatric patient, leading them to refuse the treatment.
Read the detailed description
Receiving sedation is one of the pharmacological procedures for intrathecal chemotherapy which creates a particularly difficult situation for the child. However, since pharmacological methods increase the cost and cause toxicity in children, in recent years, the symptoms that occur in cancer treatment have been tried to be controlled with non-pharmacological methods. Music intervention facilitates a sense of control in patients and provides mental distraction, emotional smoothness, and relaxation, which have been found to have pain relief effects.
- Conditions
- Nurse's Role
- Being tested
- Music intervention
- Keywords
- anxiety, hematology-oncology nursing, pain intervention, randomized controlled trial, fear
- 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 interventionBehavioural
: In addition to the routine practice of the clinic, the pediatric patients in this group listened to music through headphones for 20 minutes just before the procedure to reduce the child's anxiety and fear. The therapeutic effect of music was used. Before the study, children between the ages of 6 and 12 who were inpatients at the clinic were asked what music they most liked to listen to, what kind of music they liked, and what their favorite artists and songs were. The music was selected based on the children's answers. In addition, the researcher added children's songs by a musician named Banu Kanıbelli
| Study group | Role | What they receive |
|---|---|---|
| Music intervention group | Experimental | In addition to the routine practice of the clinic, the pediatric patients in this group listened to music through headphones for 20 minutes just before the procedure to reduce the child's anxiety and fear. The therapeutic effect of music was used. Before the study, children between the ages of 6 and 12 who were inpatients at the clinic were asked what music they most liked to listen to, what kind of music they liked, and what their favorite artists and songs were. The music was selected based on the children's answers. In addition, the researcher added children's songs by a musician named Banu Kanıbelli. Receives: Behavioral: Music intervention |
| Control Group | No intervention | Children were verbally informed about the treatment process and invasive procedures from the day they were diagnosed with the disease. The children in this group were verbally informed by the nurse in charge of the clinic about the intrathecal chemotherapy treatment and why it was performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety
Child Anxiety Meter-State (CAM-S):The scale can be scored between 1 and 10. An increase in the score means an increase in anxiety.
Measured: 30 minutes before intrathecal chemotherapy treatment and just after music intervention
fear
Children's Fear Scale (CFS): The scale can be scored between 0 and 4. An increase in the score means an increase in fear
Measured: 30 minutes before intrathecal chemotherapy treatment and just after music intervention
pain scale
Face, Legs, Activity, Cry, Consolability pain scale (FLACC): total score between 0 and 10 is obtained by assigning 0, 1, or 2 points for each category. As the severity of pain increases, the total score increases, and as the severity of pain decreases,
Measured: 60 minutes after intrathecal chemotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jan 2023
- Primary completion1 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a parallel group, randomized, controlled experimental study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Uzşen, Ondokuz Mayıs University
- Investigators
- Hatice Uzsen, PhD, Principal investigator, ondokuz mayıs üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424587
- Sponsor's protocol ID
- IT
- Status last verified
- Mar 2025
- First submitted
- 16 May 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Intervention on Anxiety, Fear, and Pain in Pediatric Patients Receiving Intrathecal Chemotherapy
- ClinicalTrials.gov ID
- NCT06424587
- Acronym / sponsor ID
- IT
- Conditions
- Nurse's Role
- Keywords
- anxiety, hematology-oncology nursing, pain intervention, randomized controlled trial, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 22 May 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.
Intrathecal chemotherapy is often used to prevent the spread of cancer to the central nervous system in pediatric patients and is one of the most invasive procedures. It is believed that the way it is administered and the complications experienced after treatment negatively affect the comfort of the pediatric patient, leading them to refuse the treatment.
Detailed description
Receiving sedation is one of the pharmacological procedures for intrathecal chemotherapy which creates a particularly difficult situation for the child. However, since pharmacological methods increase the cost and cause toxicity in children, in recent years, the symptoms that occur in cancer treatment have been tried to be controlled with non-pharmacological methods. Music intervention facilitates a sense of control in patients and provides mental distraction, emotional smoothness, and relaxation, which have been found to have pain relief effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- a parallel group, randomized, controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Music intervention group | Experimental | Behavioral: Music interventionIn addition to the routine practice of the clinic, the pediatric patients in this group listened to music through headphones for 20 minutes just before the procedure to reduce the child's anxiety and fear. The therapeutic effect of music was used. Before the study, children between the ages of 6 and 12 who were inpatients at the clinic were asked what music they most liked to listen to, what kind of music they liked, and what their favorite artists and songs were. The music was selected based on the children's answers. In addition, the researcher added children's songs by a musician named Banu Kanıbelli. |
| Control Group | No intervention | –Children were verbally informed about the treatment process and invasive procedures from the day they were diagnosed with the disease. The children in this group were verbally informed by the nurse in charge of the clinic about the intrathecal chemotherapy treatment and why it was performed |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- To be between 6-12 years old,
- Being treated in the Hematology and Oncology Clinic,
- About to receive intrathecal chemotherapy treatment,
- The child not having pain before intrathecal chemotherapy treatment
Key exclusion criteria (5 listed)
- Refusing to participate in the study,
- Being under 6 years of age and over 10 years of age,
- The child having pain prior to intrathecal chemotherapy treatment,
- Having any physical or mental disability,
- Not being able to speak Turkish.
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 intervention: In addition to the routine practice of the clinic, the pediatric patients in this group listened to music through headphones for 20 minutes just before the procedure to reduce the child's anxiety and fear. The therapeutic effect of music was used. Before the study, children between the ages of 6 and 12 who were inpatients at the clinic were asked what music they most liked to listen to, what kind of music they liked, and what their favorite artists and songs were. The music was selected based on the children's answers. In addition, the researcher added children's songs by a musician named Banu Kanıbelli | Behavioural | Music intervention group |
Primary outcome
anxiety
Time frame: 30 minutes before intrathecal chemotherapy treatment and just after music intervention
Child Anxiety Meter-State (CAM-S):The scale can be scored between 1 and 10. An increase in the score means an increase in anxiety.
fear
Time frame: 30 minutes before intrathecal chemotherapy treatment and just after music intervention
Children's Fear Scale (CFS): The scale can be scored between 0 and 4. An increase in the score means an increase in fear
pain scale
Time frame: 60 minutes after intrathecal chemotherapy treatment
Face, Legs, Activity, Cry, Consolability pain scale (FLACC): total score between 0 and 10 is obtained by assigning 0, 1, or 2 points for each category. As the severity of pain increases, the total score increases, and as the severity of pain decreases,
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 20 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Hatice Uzsen, PhD principal investigator
ondokuz mayıs üniversity
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 in people with Nurse's Role, run by Ondokuz Mayıs 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 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 20 Mar 2025. 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?
anxiety (time frame: 30 minutes before intrathecal chemotherapy treatment and just after music intervention). 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 20 Mar 2025.