AnxietyNCT07112092

Therapeutic Play and Music Therapy in Dental Anxiety

A study testing Tell-Show-Do, Music Therapy and Therapeutic Play Therapy in people with Anxiety and Behavior Management, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to evaluate the effects of therapeutic play and music therapy on dental anxiety and pain levels in pediatric patients undergoing tooth extraction. Read more about this study

Who is it for?: Ages 6 to 8 years
Conditions the study is for: Anxiety, Behavior Management, Music Therapy
What is being tested?: Tell-Show-Do, Music Therapy and Therapeutic Play Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2025to 25 May 2025
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 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

Aged 6-8 years
Scored 3 (positive) or 4 (definitely positive) on the Frankl Behavior Scale
Systemically healthy
Had no hearing impairments or allergies
Had an indication for extraction of any primary maxillary molars (54, 55, 64, 65)
Whose parents provided informed consent for participation

Who cannot join

Had systemic diseases or allergies
Scored 1 (definitely negative) or 2 (negative) on the Frankl Behavior Scale
Were undergoing psychological or psychiatric treatment
Had physical or mental disabilities

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Recep Tayyip Erdoğan University Faculty of Dentistry
Rize

Other trials in Turkey (Türkiye)

About this study

Official title: Therapeutic Play and Music Therapy in Dental Anxiety Management: A Randomised Clinical Trial

This study aims to evaluate the effects of therapeutic play and music therapy on dental anxiety and pain levels in pediatric patients undergoing tooth extraction.

Read the detailed description

A total of 126 children aged 6-8 years who required maxillary molar extraction were randomly assigned to three groups (n=42): a control group (Tell-Show-Do), a music therapy group, and a therapeutic play group. Vital signs, including heart rate, blood pressure, oxygen saturation, and body temperature, were recorded. The Modified Child Dental Anxiety Scale - faces version (MCDASf) and the Facial Image Scale (FIS) were used to assess anxiety levels before and after the extraction. Following the extraction, the Wong-Baker Faces Pain Rating Scale (WBFPRS) was used to evaluate pain levels.

Conditions: Anxiety, Behavior Management, Music Therapy
Being tested: Tell-Show-Do, Music Therapy, Therapeutic Play Therapy
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tell-Show-DoBehavioural
Standard behavioral management technique where the dental procedure is explained to the child, demonstrated, and then performed.
Music TherapyBehavioural
Participants listen to calming music during the dental extraction procedure to reduce anxiety and pain perception.
Therapeutic Play TherapyBehavioural
Use of structured play activities designed to reduce dental anxiety and improve cooperation during tooth extraction.

Study groups in NCT07112092
Study group	Role	What they receive
Group 1: (n=42) control (Tell-Show-Do) group	Active comparator	The treatment procedure and the exact steps were explained to the child verbally, after which all the tools and equipment required for the treatment were shown to the child before the extraction was performed. Receives: Behavioral: Tell-Show-Do
Group 2: (n=42) tell-show-do with music therapy application group	Experimental	The planned tooth extraction had been explained to the children using the Tell-Show-Do (TSD) technique, and each child had been asked to select a preferred song. During the procedure, the selected songs were played on a screen mounted in the dental unit. The duration of the therapy had been standardized to 10 minutes in order to relax the children's physiological and psychological state. Receives: Behavioral: Music Therapy
Group 3: (n=42) tell-show-do with therapeutic play therapy application group	Experimental	For the TSD and therapeutic play therapy groups, a play therapy-certified researcher demonstrated the procedure on a model using a plush Pink Panther toy (Youya Dental Supply Store, China) and a toy dentist set (Heroes Toys, Turkey). Children were allotted 10 minutes to roleplay the procedure, interact with the toys to facilitate emotional expression related to the procedure, and ask any questions. Receives: Behavioral: Therapeutic Play Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurement
The primary outcomes of this study were assessed through physiological measurements (blood pressure).
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded at multiple time points during the procedure: before the procedure, after the administration of local anesthesia, after pulpotomy, and at the end of the procedure.
Each patient had rested for 15 minutes prior to the blood pressure measurement. Measurements were taken from the right wrist with the child in an upright position using an automatic wrist blood pressure device (Wohler, Türkiye).
Systolic (SBP) and diastolic blood pressure (DBP) values, expressed in centimeters of mercury (cmHg), were recorded.
Measured: 1 month
Heart rate (HR) measurement
The primary outcomes of this study were assessed through physiological measurements (heart rate).
Heart rate (HR) was measured while the child was in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger. HR values displayed on the digital monitor were recorded as beats per minute.
Measured: 1 month
Hemoglobin oxygen saturation (SpO₂) measurement
The primary outcomes of this study were assessed through physiological measurements (hemoglobin oxygen saturation).
Hemoglobin oxygen saturation (SpO₂) was measured while the child was in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger. SpO₂ values displayed on the digital monitor were recorded as a percentage.
Measured: 1 month
The Faces Version of the Modified Child Dental Anxiety Scale (MCDASf) measurement
The primary outcomes of this study were assessed through psychometric measurements (The Faces Version of the Modified Child Dental Anxiety Scale).
The Faces Version of the Modified Child Dental Anxiety Scale (MCDASf) was used to measure the level of anxiety experienced by the children throughout the procedure.
This scale included five possible responses consisting of smiling or sad faces, appropriate for each answer given by the child. A happy face corresponded to 1 point, whereas a very sad face corresponded to 5 points.
After the dental treatment, the children in all three groups were asked the questions. The scores corresponding to the selected facial expressions were chosen by the children and recorded by the pediatric dentist.
The total score was calculated with a minimum of 8 and a maximum of 40, with higher scores indicating greater levels of anxiety.
Measured: 1 month
The Wong-Baker Faces Pain Rating Scale (WBFPRS) measurement
The primary outcomes of this study were assessed through evaluation of dental pain perception (The Wong-Baker Faces Pain Rating Scale).
The Wong-Baker Faces Pain Rating Scale (WBFPRS) was utilized to assess the pain intensity as reported by the children during the dental treatment.
The WBFPRS included six facial expressions ranging from a smiling face to a crying face.
These expressions were explained to the children, who were then asked to choose the face that best reflected the level of pain they felt during the treatment. A smiling face corresponded to 0 points (no pain), whereas a crying face corresponded to 10 points (very severe pain). After physiological and psychometric measurements were recorded, the pediatric dentist used the WBFPRS score to evaluate the children's pain perception. The scoring was recorded by the same pediatric dentist.
Higher dental anxiety was associated with an increasing score.
Measured: 1 month
The Facial Image Scale (FIS) measurement
The Facial Image Scale (FIS) was specifically designed for children aged 4-12 years and enabled individuals with limited verbal communication skills to express their emotions through facial expressions. The scale consisted of five different facial expressions, rated from 1 (very happy) to 5 (very sad). Children were asked to select the facial expression that best represented their feelings, and their responses were recorded. The FIS was administered both pre-procedure and post-procedure.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202525 May 2025

First posted8 Aug 2025
Study start1 Jan 2025
Primary completion25 Apr 2025
Study completion25 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
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: None (open label)
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07112092
Sponsor's protocol ID: 2024/279
Status last verified: Aug 2025
First submitted: 31 Jul 2025
Last updated: 8 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kabasakal HN, Aydinoglu S, Gunacar DN. Impact of therapeutic play and music therapy on dental anxiety and pain perception in pediatric patients: a clinical study. Sci Rep. 2026 Jan 19;16(1):5697. doi: 10.1038/s41598-026-36631-x.
PubMed 41554935

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Therapeutic Play and Music Therapy in Dental Anxiety Management: A Randomised Clinical Trial
ClinicalTrials.gov ID: NCT07112092
Acronym / sponsor ID: 2024/279
Conditions: Anxiety, Behavior Management, Music Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
Study start: 1 Jan 2025 (actual)
Primary completion: 25 Apr 2025 (actual)
Study completion: 25 May 2025 (actual)
First posted: 8 Aug 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.

This study aims to evaluate the effects of therapeutic play and music therapy on dental anxiety and pain levels in pediatric patients undergoing tooth extraction.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1: (n=42) control (Tell-Show-Do) group	Active comparator	Behavioral: Tell-Show-DoThe treatment procedure and the exact steps were explained to the child verbally, after which all the tools and equipment required for the treatment were shown to the child before the extraction was performed.
Group 2: (n=42) tell-show-do with music therapy application group	Experimental	Behavioral: Music TherapyThe planned tooth extraction had been explained to the children using the Tell-Show-Do (TSD) technique, and each child had been asked to select a preferred song. During the procedure, the selected songs were played on a screen mounted in the dental unit. The duration of the therapy had been standardized to 10 minutes in order to relax the children's physiological and psychological state.
Group 3: (n=42) tell-show-do with therapeutic play therapy application group	Experimental	Behavioral: Therapeutic Play TherapyFor the TSD and therapeutic play therapy groups, a play therapy-certified researcher demonstrated the procedure on a model using a plush Pink Panther toy (Youya Dental Supply Store, China) and a toy dentist set (Heroes Toys, Turkey). Children were allotted 10 minutes to roleplay the procedure, interact with the toys to facilitate emotional expression related to the procedure, and ask any questions.

Who may qualify

Ages: 6 to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Aged 6-8 years
Scored 3 (positive) or 4 (definitely positive) on the Frankl Behavior Scale
Systemically healthy
Had no hearing impairments or allergies
Had an indication for extraction of any primary maxillary molars (54, 55, 64, 65)

Key exclusion criteria (4 listed)

Had systemic diseases or allergies
Scored 1 (definitely negative) or 2 (negative) on the Frankl Behavior Scale
Were undergoing psychological or psychiatric treatment
Had physical or mental disabilities

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
Tell-Show-DoStandard behavioral management technique where the dental procedure is explained to the child, demonstrated, and then performed.	Behavioural	Group 1: (n=42) control (Tell-Show-Do) group
Music TherapyParticipants listen to calming music during the dental extraction procedure to reduce anxiety and pain perception.	Behavioural	Group 2: (n=42) tell-show-do with music therapy application group
Therapeutic Play TherapyUse of structured play activities designed to reduce dental anxiety and improve cooperation during tooth extraction.	Behavioural	Group 3: (n=42) tell-show-do with therapeutic play therapy application group

Primary outcome

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurement
Time frame: 1 month
The primary outcomes of this study were assessed through physiological measurements (blood pressure). Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded at multiple time points during the procedure: before the procedure, after the administration of local anesthesia, after pulpotomy, and at the end of the procedure. Each patient had rested for 15 minutes prior to the blood pressure measurement. Measurements were taken from the right wrist with the child in an upright position using an automatic wrist blood pressure device (Wohler, Türkiye). Systolic (SBP) and diastolic blood pressure (DBP) values, expressed in centimeters of mercury (cmHg), were recorded.
Heart rate (HR) measurement
Time frame: 1 month
The primary outcomes of this study were assessed through physiological measurements (heart rate). Heart rate (HR) was measured while the child was in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger. HR values displayed on the digital monitor were recorded as beats per minute.
Hemoglobin oxygen saturation (SpO₂) measurement
Time frame: 1 month
The primary outcomes of this study were assessed through physiological measurements (hemoglobin oxygen saturation). Hemoglobin oxygen saturation (SpO₂) was measured while the child was in a seated position using a finger-type portable pulse oximeter (Oncomed, USA) attached to the child's right finger. SpO₂ values displayed on the digital monitor were recorded as a percentage.
The Faces Version of the Modified Child Dental Anxiety Scale (MCDASf) measurement
Time frame: 1 month
The primary outcomes of this study were assessed through psychometric measurements (The Faces Version of the Modified Child Dental Anxiety Scale). The Faces Version of the Modified Child Dental Anxiety Scale (MCDASf) was used to measure the level of anxiety experienced by the children throughout the procedure. This scale included five possible responses consisting of smiling or sad faces, appropriate for each answer given by the child. A happy face corresponded to 1 point, whereas a very sad face corresponded to 5 points. After the dental treatment, the children in all three groups were asked the questions. The scores corresponding to the selected facial expressions were chosen by the children and recorded by the pediatric dentist. The total score was calculated with a minimum of 8 and a maximum of 40, with higher scores indicating greater levels of anxiety.
The Wong-Baker Faces Pain Rating Scale (WBFPRS) measurement
Time frame: 1 month
The primary outcomes of this study were assessed through evaluation of dental pain perception (The Wong-Baker Faces Pain Rating Scale). The Wong-Baker Faces Pain Rating Scale (WBFPRS) was utilized to assess the pain intensity as reported by the children during the dental treatment. The WBFPRS included six facial expressions ranging from a smiling face to a crying face. These expressions were explained to the children, who were then asked to choose the face that best reflected the level of pain they felt during the treatment. A smiling face corresponded to 0 points (no pain), whereas a crying face corresponded to 10 points (very severe pain). After physiological and psychometric measurements were recorded, the pediatric dentist used the WBFPRS score to evaluate the children's pain perception. The scoring was recorded by the same pediatric dentist. Higher dental anxiety was associated with an increasing score.
The Facial Image Scale (FIS) measurement
Time frame: 1 month
The Facial Image Scale (FIS) was specifically designed for children aged 4-12 years and enabled individuals with limited verbal communication skills to express their emotions through facial expressions. The scale consisted of five different facial expressions, rated from 1 (very happy) to 5 (very sad). Children were asked to select the facial expression that best represented their feelings, and their responses were recorded. The FIS was administered both pre-procedure and post-procedure.

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 8 Aug 2025.
Derived from this study: PubMed 41554935Kabasakal HN, Aydinoglu S, Gunacar DN. Impact of therapeutic play and music therapy on dental anxiety and pain perception in pediatric patients: a clinical study. Sci Rep. 2026 Jan 19;16(1):5697. doi: 10.1038/s41598-026-36631-x.
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.

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?

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 6 inclusion and 4 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 8 Aug 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?

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurement (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07112092, which also lists 1 linked publication.

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 8 Aug 2025.