Music TherapyNCT06996795
Effects of Music Therapy on Sensory Processing, Adaptive Behavior and Social Interaction
A study testing music therapy and sensory integration in people with Music Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of our study is to examine the effects of music therapy on sensory processing, adaptive behavior, and social interaction in individuals with autism. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Music Therapy
- What is being tested?
- music therapy and sensory integration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Aug 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having been diagnosed with autism spectrum disorder (ASD) by a child psychiatrist Being between the ages of 6-10 being able to cooperate
Who cannot join
- Having any neurological, orthopedic or psychiatric diagnosis in addition to autism diagnosis Having undergone any surgical intervention in the last 3 months Being inadequate in understanding visual and auditory commands Having a visual and hearing impairment recorded in the health report
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigating the Effects of Music Therapy on Sensory Processing, Adaptive Behavior and Social Interaction in Children With Autism
The purpose of our study is to examine the effects of music therapy on sensory processing, adaptive behavior, and social interaction in individuals with autism.
Read the detailed description
The study was designed as a randomized controlled trial. A simple randomization method will be used to randomly assign individuals to two groups (intervention and control groups). A simple randomization method will be used where the intervention and control group papers are selected from a sealed envelope. Following the initial assessment of each participant, one of the papers labeled "intervention" or "control" will be randomly selected. This decision will determine whether the individual will be assigned to the intervention or control group. The study will be conducted at Hacettepe University. The study group and the control group will receive sensory integration training for 45 minutes per day, 2 days per week, for 6 weeks. The children in the control group will receive only sensory integration training, while the study group will receive music therapy training for 30 minutes per day, 2 days per week, for 6 weeks in addition to sensory integration training. Sociodemographic information of the children will be collected before the research and sensory processing problems of the children will be assessed with the Sensory Profile and adaptive behavioral skills will be assessed with the Adaptive Behavior Scale (ADS).
- Conditions
- Music Therapy
- Being tested
- music therapy, sensory integration
- Keywords
- autism, sensory integration, music therapy, sensory processing, social interaction
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyBehavioural
Music therapy will be applied with drums, maracas, cymbals and orf instruments. It will consist of body rhythms, breathing exercises and rhythm studies.
sensory integrationBehavioural
Sensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies.
| Study group | Role | What they receive |
|---|---|---|
| sensory integration training and music therapy | Active comparator | The intervention group will receive both sensory integration training and music therapy. Sensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies. Music therapy will be applied with drums, maracas, cymbals and orf instruments. It will consist of body rhythms, breathing exercises and rhythm studies. Receives: Behavioral: music therapy; Behavioral: sensory integration |
| sensory integration training | Active comparator | The control group will receive sensory integration training. Sensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies. Receives: Behavioral: sensory integration |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory profile
Sensory Profile: This assessment tool is used to determine the sensory profiles of children between the ages of 3-10. The test consists of 125 questions and a parent/caregiver with whom the child has one-on-one communication in his/her daily life answers the test questions. The test consists of three main sections: sensory processing, modulation and behavioral and emotional responses. The subsections of each main section consist of a total of 14 sections and 125 questions. The test takes approximately 30 minutes to administer. You are asked to mark one of the options: always, often, sometimes, occasionally and never. The assessment results are found by scoring from 1 to 5, giving 5 points to "never" and 1 point to "always". In this assessment, 1 point reflects a situation where there is a disordered behavior related to the sensory profile and 5 points reflects a situation where there is normal behavior. The Turkish adaptation of this test was made.
Measured: 1 month
Secondary outcomes (1)
Adaptive Behavior Scale
Adaptive Behavior Scale (ABS): The scale evaluates the child's adaptive behavior according to two basic criteria: the person's possession of basic skills such as self-care and personal hygiene, and avoiding behaviors that are not accepted by the environment, such as harming others and using physical violence. The Turkish validity study of the Adaptive Behavior Scale was conducted. The Adaptive Behavior Scale consists of two sections. The first section evaluates the skills and habits in nine behavioral areas that are important for the individual's development of independence in daily life. The second section is designed to measure non-adaptive behavior related to personality and behavioral disorders. If the behavior occurs "occasionally", "1" is marked, and if it occurs "frequently", "2" is marked. 25-30 minutes is considered sufficient for the application of the scale.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Jul 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with an intervention group and a control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kaya Ozturk, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996795
- Sponsor's protocol ID
- HÜ-OT-LKO-05
- Status last verified
- Jul 2025
- First submitted
- 21 May 2025
- Last updated
- 31 Jul 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Music Therapy on Sensory Processing, Adaptive Behavior and Social Interaction in Children With Autism
- ClinicalTrials.gov ID
- NCT06996795
- Acronym / sponsor ID
- HÜ-OT-LKO-05
- Conditions
- Music Therapy
- Keywords
- autism, sensory integration, music therapy, sensory processing, social interaction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 30 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.
The purpose of our study is to examine the effects of music therapy on sensory processing, adaptive behavior, and social interaction in individuals with autism.
Detailed description
The study was designed as a randomized controlled trial. A simple randomization method will be used to randomly assign individuals to two groups (intervention and control groups). A simple randomization method will be used where the intervention and control group papers are selected from a sealed envelope. Following the initial assessment of each participant, one of the papers labeled "intervention" or "control" will be randomly selected. This decision will determine whether the individual will be assigned to the intervention or control group. The study will be conducted at Hacettepe University. The study group and the control group will receive sensory integration training for 45 minutes per day, 2 days per week, for 6 weeks. The children in the control group will receive only sensory integration training, while the study group will receive music therapy training for 30 minutes per day, 2 days per week, for 6 weeks in addition to sensory integration training. Sociodemographic information of the children will be collected before the research and sensory processing problems of the children will be assessed with the Sensory Profile and adaptive behavioral skills will be assessed with the Adaptive Behavior Scale (ADS).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with an intervention group and a control group
| Arm | Type | Receives |
|---|---|---|
| sensory integration training and music therapy | Active comparator | Behavioral: music therapy, Behavioral: sensory integrationThe intervention group will receive both sensory integration training and music therapy. Sensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies. Music therapy will be applied with drums, maracas, cymbals and orf instruments. It will consist of body rhythms, breathing exercises and rhythm studies. |
| sensory integration training | Active comparator | Behavioral: sensory integrationThe control group will receive sensory integration training. Sensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Having been diagnosed with autism spectrum disorder (ASD) by a child psychiatrist Being between the ages of 6-10 being able to cooperate
Key exclusion criteria (1 listed)
- Having any neurological, orthopedic or psychiatric diagnosis in addition to autism diagnosis Having undergone any surgical intervention in the last 3 months Being inadequate in understanding visual and auditory commands Having a visual and hearing impairment recorded in the health report
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 therapyMusic therapy will be applied with drums, maracas, cymbals and orf instruments. It will consist of body rhythms, breathing exercises and rhythm studies. | Behavioural | sensory integration training and music therapy |
| sensory integrationSensory integration will include sensory modulation activities, vestibular, proprioceptive, tactile, visual and auditory sensory studies. | Behavioural | sensory integration training, sensory integration training and music therapy |
Primary outcome
sensory profile
Time frame: 1 month
Sensory Profile: This assessment tool is used to determine the sensory profiles of children between the ages of 3-10. The test consists of 125 questions and a parent/caregiver with whom the child has one-on-one communication in his/her daily life answers the test questions. The test consists of three main sections: sensory processing, modulation and behavioral and emotional responses. The subsections of each main section consist of a total of 14 sections and 125 questions. The test takes approximately 30 minutes to administer. You are asked to mark one of the options: always, often, sometimes, occasionally and never. The assessment results are found by scoring from 1 to 5, giving 5 points to "never" and 1 point to "always". In this assessment, 1 point reflects a situation where there is a disordered behavior related to the sensory profile and 5 points reflects a situation where there is normal behavior. The Turkish adaptation of this test was made.
1 secondary outcome
Adaptive Behavior Scale
Time frame: 1 month
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 31 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy and sensory integration in people with Music Therapy, run by Hacettepe 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 1 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: enrolling by invitation, as of the sponsor's last update on 31 Jul 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?
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?
sensory profile (time frame: 1 month). 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 31 Jul 2025.