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Completed

NCT Number: NCT07112092

Therapeutic Play and Music Therapy in Dental Anxiety

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Management Mental Disorders Music Therapy

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tell-Show-Do

Behavioral

Standard behavioral management technique where the dental procedure is explained to the child, demonstrated, and then performed.

Music Therapy

Behavioral

Participants listen to calming music during the dental extraction procedure to reduce anxiety and pain perception.

Therapeutic Play Therapy

Behavioral

Use of structured play activities designed to reduce dental anxiety and improve cooperation during tooth extraction.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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