TonsillectomyNCT07433296
THE EFFECT OF SANDPLAY THERAPY ON THE ANXİETY AND PAİN LEVELS OF CHİLDREN DURİNG PREOPERATİVE PERİOD
A study testing Sand Play Therapy in people with Tonsillectomy and Postoperative Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to investigate the effects of preoperative sand play therapy on anxiety and pain levels in school-aged children (7-10 years old). The study was conducted with 68 children undergoing tonsillectomy, divided into an experimental group (sand play intervention) and a control group… Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Tonsillectomy, Postoperative Pain, Preoperative Anxiety
- What is being tested?
- Sand Play Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Jul 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 7 and 10 years
- Scheduled for tonsillectomy surgery
- Able to communicate verbally
- No visual, hearing, or cognitive impairment Exclusion criteria
- History of previous surgery
- Diagnosed neurological or developmental disorders
- Presence of chronic disease
- Postoperative physiological instability
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Training and Research Hospital
Samsun, Samsun, 55090
About this study
Official title: THE EFFECT OF SAND PLAY METHOD APPLİED TO CHİLDREN İN THE PRE-OPERATİVE PERİOD ON CHİLDREN'S ANXİETY AND PAİN LEVELS
This randomized controlled trial aims to investigate the effects of preoperative sand play therapy on anxiety and pain levels in school-aged children (7-10 years old). The study was conducted with 68 children undergoing tonsillectomy, divided into an experimental group (sand play intervention) and a control group (routine care). Anxiety levels were measured using the Child Anxiety Scale-State (CAAS) and the Yale Modified Preoperative Anxiety Scale (mYPAS), while pain levels were assessed using the Wong-Baker Faces Pain Rating Scale. The study evaluates whether sand play before surgery is an effective non-pharmacological method for reducing preoperative anxiety and postoperative pain.
Read the detailed description
The aim of this randomized controlled study was to evaluate the effect of sand play therapy administered during the preoperative period on anxiety and postoperative pain levels in children undergoing tonsillectomy.
Children aged 7 to 10 years were randomly assigned to either the intervention group (sand play therapy) or the control group (routine care). Preoperative anxiety levels were assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS-C) at baseline (30 minutes before surgery) and immediately prior to anesthesia induction. Postoperative pain was measured 1 hour after surgery using the Wong-Baker Faces Pain Rating Scale. In addition, state anxiety levels were evaluated using the CAM-S scale on the evening before surgery, 30 minutes prior to surgery, and 1 hour postoperatively.
- Conditions
- Tonsillectomy, Postoperative Pain, Preoperative Anxiety
- Being tested
- Sand Play Therapy
- Keywords
- pain, anxiety, child, surgery
- Medical subject headings
- Pain, Postoperative, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sand Play TherapyBehavioural
This randomized controlled trial represents an advancement in considering sand play as an intervention applied in the pre-operative period, and it enhances its applicability and clinical success.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Sand Play) | Experimental | Unlike the control group, a therapeutic play program was applied to the children one hour before surgery by the certified researcher in this group. The therapeutic play program was conducted in the child's room for 30 minutes. Materials used for the play included colored sand, a sand tray, a sand shaping set, a doll, a toy car, a mask, a cap, a toy doctor's set, colored pencils, drawing paper, and an ice cream cone. The child was given the opportunity to ask questions about things they were curious about to gain their trust. Then, the sand tray was filled with sand having the color chosen by the child, and the toys they selected were placed inside for them to play (the sand was given to each child in individual packets, and the materials were sterilized).
Faces Pain Rating Scale (Wong Baker) was applied to assess pain following the surgery in both groups. The child and the parent were asked to complete Children's Anxiety Meter-State. Receives: Behavioral: Sand Play Therapy |
| Control Group | No intervention | The parents who agreed to participate in the study completed an "Informed Consent Form" and a "SocioDemographic Information Form" through face-to-face interviews in the evening before the surgery. An educational booklet was given to the families, and they were asked to read it to their child before the surgery. During the preoperative routine care, the child and family received necessary information about the pre- and post-operative procedures from the ward nurse and the researcher, including vital sign monitoring of the child and the medication prescribed by the physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Modified Yale Preoperative Anxiety Scale-Child Version (mYPAS-C)
The Modified Yale Preoperative Anxiety Scale - Child Version (mYPAS-C) is an observational tool used to assess preoperative anxiety in children. The scale consists of 22 items and scores range from 23.33 to 100, with higher scores indicating higher levels of anxiety.
Measured: Baseline (30 minutes before surgery) and immediately before anesthesia induction
Children's Anxiety Meter-State (CAM-S)
The Children's Anxiety Meter - State (CAM-S) is a self-report scale used to assess state anxiety in children. The scale ranges from 0 to 10, with higher scores indicating higher levels of anxiety.
Measured: The evening before surgery, 30 minutes before surgery, and 1 hour after surgery
Wong Baker Faces Pain Rating Scale
The Wong-Baker Faces Pain Rating Scale is used to assess pain intensity in children. The scale consists of six faces representing increasing pain levels and scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Oct 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillectomyStudies 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
- Study sample was assigned to experimental and control groups with simple randomization method. Both groups are followed simultaneously from the preoperative period through the postoperative assessment.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde GÜNDÜZ, Ondokuz Mayıs University
- Investigators
- Esra TURAL BÜYÜK, Assoc. Prof, Study chair, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433296
- Sponsor's protocol ID
- OMU-2022-588
- Other IDs
- BAP04-B-2024-5060
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared to protect participant privacy and maintain confidentiality as per the ethical committee approval.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF SAND PLAY METHOD APPLİED TO CHİLDREN İN THE PRE-OPERATİVE PERİOD ON CHİLDREN'S ANXİETY AND PAİN LEVELS
- ClinicalTrials.gov ID
- NCT07433296
- Acronym / sponsor ID
- OMU-2022-588
- Conditions
- Tonsillectomy, Postoperative Pain, Preoperative Anxiety
- Keywords
- pain, anxiety, child, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 25 Feb 2026 (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 randomized controlled trial aims to investigate the effects of preoperative sand play therapy on anxiety and pain levels in school-aged children (7-10 years old). The study was conducted with 68 children undergoing tonsillectomy, divided into an experimental group (sand play intervention) and a control group (routine care). Anxiety levels were measured using the Child Anxiety Scale-State (CAAS) and the Yale Modified Preoperative Anxiety Scale (mYPAS), while pain levels were assessed using the Wong-Baker Faces Pain Rating Scale. The study evaluates whether sand play before surgery is an effective non-pharmacological method for reducing preoperative anxiety and postoperative pain.
Detailed description
The aim of this randomized controlled study was to evaluate the effect of sand play therapy administered during the preoperative period on anxiety and postoperative pain levels in children undergoing tonsillectomy.
Children aged 7 to 10 years were randomly assigned to either the intervention group (sand play therapy) or the control group (routine care). Preoperative anxiety levels were assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS-C) at baseline (30 minutes before surgery) and immediately prior to anesthesia induction. Postoperative pain was measured 1 hour after surgery using the Wong-Baker Faces Pain Rating Scale. In addition, state anxiety levels were evaluated using the CAM-S scale on the evening before surgery, 30 minutes prior to surgery, and 1 hour postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study sample was assigned to experimental and control groups with simple randomization method. Both groups are followed simultaneously from the preoperative period through the postoperative assessment.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Sand Play) | Experimental | Behavioral: Sand Play TherapyUnlike the control group, a therapeutic play program was applied to the children one hour before surgery by the certified researcher in this group. The therapeutic play program was conducted in the child's room for 30 minutes. Materials used for the play included colored sand, a sand tray, a sand shaping set, a doll, a toy car, a mask, a cap, a toy doctor's set, colored pencils, drawing paper, and an ice cream cone. The child was given the opportunity to ask questions about things they were curious about to gain their trust. Then, the sand tray was filled with sand having the color chosen by the child, and the toys they selected were placed inside for them to play (the sand was given to each child in individual packets, and the materials were sterilized). Faces Pain Rating Scale (Wong Baker) was applied to assess pain following the surgery in both groups. The child and the parent were asked to complete Children's Anxiety Meter-State. |
| Control Group | No intervention | –The parents who agreed to participate in the study completed an "Informed Consent Form" and a "SocioDemographic Information Form" through face-to-face interviews in the evening before the surgery. An educational booklet was given to the families, and they were asked to read it to their child before the surgery. During the preoperative routine care, the child and family received necessary information about the pre- and post-operative procedures from the ward nurse and the researcher, including vital sign monitoring of the child and the medication prescribed by the physician. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged between 7 and 10 years
- Scheduled for tonsillectomy surgery
- Able to communicate verbally
- No visual, hearing, or cognitive impairment Exclusion criteria
- History of previous surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Sand Play TherapyThis randomized controlled trial represents an advancement in considering sand play as an intervention applied in the pre-operative period, and it enhances its applicability and clinical success. | Behavioural | Experimental Group (Sand Play) |
Primary outcome
The Modified Yale Preoperative Anxiety Scale-Child Version (mYPAS-C)
Time frame: Baseline (30 minutes before surgery) and immediately before anesthesia induction
The Modified Yale Preoperative Anxiety Scale - Child Version (mYPAS-C) is an observational tool used to assess preoperative anxiety in children. The scale consists of 22 items and scores range from 23.33 to 100, with higher scores indicating higher levels of anxiety.
Children's Anxiety Meter-State (CAM-S)
Time frame: The evening before surgery, 30 minutes before surgery, and 1 hour after surgery
The Children's Anxiety Meter - State (CAM-S) is a self-report scale used to assess state anxiety in children. The scale ranges from 0 to 10, with higher scores indicating higher levels of anxiety.
Wong Baker Faces Pain Rating Scale
Time frame: 1 hour after surgery
The Wong-Baker Faces Pain Rating Scale is used to assess pain intensity in children. The scale consists of six faces representing increasing pain levels and scores range from 0 to 10, with higher scores indicating greater pain intensity.
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 25 Feb 2026.
- Individual participant dataSharing planned: No. The individual participant data will not be shared to protect participant privacy and maintain confidentiality as per the ethical committee approval.
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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.
Esra TURAL BÜYÜK, Assoc. Prof study chair
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sand Play Therapy in people with Tonsillectomy and Postoperative Pain, 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 8 inclusion and 0 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 25 Feb 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?
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?
The Modified Yale Preoperative Anxiety Scale-Child Version (mYPAS-C) (time frame: Baseline (30 minutes before surgery) and immediately before anesthesia induction). 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 25 Feb 2026.