AnxietyNCT06955338
Music and VR Effects on Pain, Anxiety, and Fear During Oral Mucositis Care in Leukaemic Children
A study testing Music intervention and Virtual reality in people with Anxiety and Pain, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Children undergoing leukaemia treatment are exposed to a wide range of chemotherapeutic agents and immunosuppressive therapies during treatment and are therefore at great risk for complications. Mucositis is one of the leading chemotherapy-related complications affecting the quality of life of the child. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- What is being tested?
- Music intervention and Virtual reality
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 1 Dec 2027
- 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
- The participant child
- is between the ages of 6-12 years
- is being followed up as an inpatient in the Paediatric Haematology Clinic
- is receiving leukaemia treatment only
- has oral mucositis
- does not have a systemic infection
Show all 9Show fewer
- willing to participate in the study
- speak Turkish and are open to communication
- has no visual and hearing problems (not using glasses or hearing aids)
Who cannot join
- Cases not fulfilling the inclusion criteria will be excluded from the study.
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
Ege University
Izmir, 35100
Seval UĞUR ÇAKMAK, Registered Nurse, M.Sc., 00905443173536, sevalugur_35@hotmail.com
About this study
Official title: The Effect of Music Recital and Virtual Reality on Pain, Anxiety and Fear During Oral Mucositis Care in Children With Leukaemia: A Randomised Controlled Study
Children undergoing leukaemia treatment are exposed to a wide range of chemotherapeutic agents and immunosuppressive therapies during treatment and are therefore at great risk for complications. Mucositis is one of the leading chemotherapy-related complications affecting the quality of life of the child. Although it varies according to the degree of mucositis, oral mucosal erythema, white plaques and ulcers are extremely painful and traumatising procedures for pediatric patients during mucositis care. The pain and fear they experience during the procedure may lead children to delay/not perform oral mucositis care or not allow their parents to do so. Since mucositis is a painful condition in children, it is recommended to use distracting nonpharmacological methods that can help reduce the pain and fear of children during mucositis care. In this context, the aim of this study was to determine the effects of music and virtual reality on pain, anxiety and fear during oral mucositis care in children aged 6-12 years receiving leukaemia treatment. Block randomisation (gender (F/M) and age groups (6-9/10-12) will be used to identify participants. Five minutes before the oral mucositis care procedure, all participants, regardless of group, will be assessed with the Child Anxiety Scale-Disposition (CAS-D), Child Fear Scale and Visual Analogue Scale (VAS). The study will be conducted in three groups as control group, VR group and music group. Descriptive characteristics of dependent and independent categorical variables will be given as number and percentage, numerical descriptive characteristics will be given as mean and standard deviation. In examining the relationship between dependent and independent variables, Mann Whitney-Kruskal Wallis or Student t-Anova analyses will be performed according to the result of the analysis of conformity to normal distribution. Bonferroni analysis will be used for pairwise comparisons and Covariance analysis will be used to investigate the effect of variables with children.
- Being tested
- Music intervention, Virtual reality
- Keywords
- leukemia, mucositis, fear, anxiety, pain, children, nursing, symptom management
- Medical subject headings
- Anxiety Disorders, Pain, Leukemia, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionProcedure or surgery
The music for the study will be the 'MusiCure® 9 Scandinavia' compositions specially developed by Inge Eje and Niels Eje (Gefion Records, Copenhagen, Denmark) (MusiCure, 2024). The compositions include melodies with harp, cello, strings and sounds from nature (birds, forest and night sounds) in a soft rhythm between 60-80 bpm for relaxation, based on research into the acoustic environment of hospitals and shown to have a positive effect on patients' symptoms such as pain, fear and anxiety. Two minutes after the child starts listening to the music, oral mucositis care will be started. Five minutes after the end of the procedure, the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale and Visual Comparison Scale will be applied and the duration of the procedure will be recorded.
Virtual realityProcedure or surgery
In this group, children will be shown a short film with virtual reality glasses. In the study, the short film 'MusiCure® The Journey' specially developed by Inge Eje and Niels Eje (Gefion Records, Copenhagen, Denmark) will be preferred in the virtual reality group. The duration of the film is 16 minutes (MusiCure, 2024). Two minutes after the child starts watching the film, oral mucositis care will be started. Five minutes after the end of the procedure, the duration of the procedure will be recorded by applying the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale and Visual Comparison Scale.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | No intervention | Not described |
| Group2 | Active comparator | Relaxing Music Session Receives: Procedure: Music intervention |
| Group3 | Active comparator | Short Film Session via VR (Relaxing Nature) Receives: Procedure: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedural pain
The difference in pain score in different groups will be recorded.
Measured: Five minutes before starting the mucositis care procedure, the child's pain will be measured and baseline pain data will be collected. Pain data will be collected again immediately after the mucositis care procedure is completed.
anxiety
The difference in anxiety score in different groups will be recorded.
Measured: Five minutes before starting the mucositis care procedure, the child's anxiety will be measured and baseline data will be collected. Anxiety data will be collected again immediately after the mucositis care procedure is completed.
fear
The difference in fear score in different groups will be recorded.
Measured: Five minutes before starting the mucositis care procedure, the child's fear will be measured and baseline fear data will be collected. Fear data will be collected again immediately after the mucositis care procedure is completed.
Secondary outcomes (2)
duration of crying
The study will record the differences in crying times of children in different groups.
Measured: After the procedure is explained to fam/child, the duration of crying will be recorded in all groups during the mucositis intervention. The recording will last till the last moment when the equipment used for care is removed from the mouth
duration of oral mucositis care
The difference in processing time in different groups will be recorded.
Measured: After the procedure is explained to fam/child, the duration of procedure will be recorded in all groups. The recording will last till the last moment when the equipment used for care is removed from the mouth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Ege 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
- randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDA ARDAHAN SEVGİLİ, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955338
- Sponsor's protocol ID
- 07.03.2025/2100
- Status last verified
- May 2026
- First submitted
- 22 Apr 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will not be shared for ethical reasons.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Recital and Virtual Reality on Pain, Anxiety and Fear During Oral Mucositis Care in Children With Leukaemia: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06955338
- Acronym / sponsor ID
- 07.03.2025/2100
- Keywords
- leukemia, mucositis, fear, anxiety, pain, children, nursing, symptom management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 May 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.
Children undergoing leukaemia treatment are exposed to a wide range of chemotherapeutic agents and immunosuppressive therapies during treatment and are therefore at great risk for complications. Mucositis is one of the leading chemotherapy-related complications affecting the quality of life of the child. Although it varies according to the degree of mucositis, oral mucosal erythema, white plaques and ulcers are extremely painful and traumatising procedures for pediatric patients during mucositis care. The pain and fear they experience during the procedure may lead children to delay/not perform oral mucositis care or not allow their parents to do so. Since mucositis is a painful condition in children, it is recommended to use distracting nonpharmacological methods that can help reduce the pain and fear of children during mucositis care. In this context, the aim of this study was to determine the effects of music and virtual reality on pain, anxiety and fear during oral mucositis care in children aged 6-12 years receiving leukaemia treatment. Block randomisation (gender (F/M) and age groups (6-9/10-12) will be used to identify participants. Five minutes before the oral mucositis care procedure, all participants, regardless of group, will be assessed with the Child Anxiety Scale-Disposition (CAS-D), Child Fear Scale and Visual Analogue Scale (VAS). The study will be conducted in three groups as control group, VR group and music group. Descriptive characteristics of dependent and independent categorical variables will be given as number and percentage, numerical descriptive characteristics will be given as mean and standard deviation. In examining the relationship between dependent and independent variables, Mann Whitney-Kruskal Wallis or Student t-Anova analyses will be performed according to the result of the analysis of conformity to normal distribution. Bonferroni analysis will be used for pairwise comparisons and Covariance analysis will be used to investigate the effect of variables with children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group1 | No intervention | – |
| Group2 | Active comparator | Procedure: Music interventionRelaxing Music Session |
| Group3 | Active comparator | Procedure: Virtual realityShort Film Session via VR (Relaxing Nature) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- The participant child
- is between the ages of 6-12 years
- is being followed up as an inpatient in the Paediatric Haematology Clinic
- is receiving leukaemia treatment only
- has oral mucositis
Key exclusion criteria (1 listed)
- Cases not fulfilling the inclusion criteria will be excluded from the study.
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 interventionThe music for the study will be the 'MusiCure® 9 Scandinavia' compositions specially developed by Inge Eje and Niels Eje (Gefion Records, Copenhagen, Denmark) (MusiCure, 2024). The compositions include melodies with harp, cello, strings and sounds from nature (birds, forest and night sounds) in a soft rhythm between 60-80 bpm for relaxation, based on research into the acoustic environment of hospitals and shown to have a positive effect on patients' symptoms such as pain, fear and anxiety. Two minutes after the child starts listening to the music, oral mucositis care will be started. Five minutes after the end of the procedure, the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale and Visual Comparison Scale will be applied and the duration of the procedure will be recorded. | Procedure or surgery | Group2 |
| Virtual realityIn this group, children will be shown a short film with virtual reality glasses. In the study, the short film 'MusiCure® The Journey' specially developed by Inge Eje and Niels Eje (Gefion Records, Copenhagen, Denmark) will be preferred in the virtual reality group. The duration of the film is 16 minutes (MusiCure, 2024). Two minutes after the child starts watching the film, oral mucositis care will be started. Five minutes after the end of the procedure, the duration of the procedure will be recorded by applying the Child Anxiety Scale-Conditioning (CAS-D), Child Fear Scale and Visual Comparison Scale. | Procedure or surgery | Group3 |
Primary outcome
procedural pain
Time frame: Five minutes before starting the mucositis care procedure, the child's pain will be measured and baseline pain data will be collected. Pain data will be collected again immediately after the mucositis care procedure is completed.
The difference in pain score in different groups will be recorded.
anxiety
Time frame: Five minutes before starting the mucositis care procedure, the child's anxiety will be measured and baseline data will be collected. Anxiety data will be collected again immediately after the mucositis care procedure is completed.
The difference in anxiety score in different groups will be recorded.
fear
Time frame: Five minutes before starting the mucositis care procedure, the child's fear will be measured and baseline fear data will be collected. Fear data will be collected again immediately after the mucositis care procedure is completed.
The difference in fear score in different groups will be recorded.
2 secondary outcomes
duration of crying
Time frame: After the procedure is explained to fam/child, the duration of crying will be recorded in all groups during the mucositis intervention. The recording will last till the last moment when the equipment used for care is removed from the mouth
duration of oral mucositis care
Time frame: After the procedure is explained to fam/child, the duration of procedure will be recorded in all groups. The recording will last till the last moment when the equipment used for care is removed from the mouth
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 19 May 2026.
- Individual participant dataSharing planned: No. Patient data will not be shared for ethical reasons.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
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 Virtual reality in people with Anxiety and Pain, run by Ege 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 9 inclusion and 1 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: opening soon, as of the sponsor's last update on 19 May 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?
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?
Contact Seda ARDAHAN SEVGİLİ, Ph.D. (00902323115572, sedardahan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procedural pain (time frame: Five minutes before starting the mucositis care procedure, the child's pain will be measured and baseline pain data will be collected. Pain data will be collected again immediately after the mucositis care procedure is completed.). 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 19 May 2026.