Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BAP04-B-2024-5060 | Other Grant/Funding Number | ONDOKUZ MAYIS UNIVERSITY BAP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sand Play Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 1 hour after surgery |
Not provided
Not provided
Inclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Esra TURAL BÜYÜK, Assoc. Prof | Ondokuz Mayıs University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsun Training and Research Hospital | Samsun | Samsun | 55090 | Turkey (Türkiye) |
The individual participant data will not be shared to protect participant privacy and maintain confidentiality as per the ethical committee approval.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |