Perioperative AnxietyNCT06868420
Efficacy of Play Therapy for the Reduction of Perioperative Anxiety in Pediatric Patients
A study testing Play therapy with transport cart in people with Perioperative Anxiety, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The goal of this randomized controlled clinical trial was to determine the efficacy of play therapy in reducing perioperative anxiety in pediatric patients aged 3 to 6 years undergoing inguinal hernia surgery. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Perioperative Anxiety
- What is being tested?
- Play therapy with transport cart
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteMexico
- Study dates
- 19 Jan 2023to 20 Mar 2024
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 3 to 6 years.
- Patients of any sex.
- Patients scheduled for elective inguinal hernioplasty.
- Patients undergoing their first anesthetic-surgical procedure.
- Patients whose legal guardian provided informed consent.
Who cannot join
- Patients with known allergy to midazolam.
- Patients with abnormal perinatal history (e.g., neonatal hypoxia or chromosomal abnormalities).
- Patients undergoing emergency inguinal hernioplasty due to complications such as strangulation or incarceration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Play Therapy for the Reduction of Perioperative Anxiety in Pediatric Patients Aged 3 to 6 Years Undergoing Inguinal Hernioplasty
The goal of this randomized controlled clinical trial was to determine the efficacy of play therapy in reducing perioperative anxiety in pediatric patients aged 3 to 6 years undergoing inguinal hernia surgery.
The main research question was:
Read more
Was play therapy effective in reducing perioperative anxiety levels in pediatric patients undergoing inguinal hernia repair?
Primary outcome measure: Anxiety level.
Patients were randomized into two groups:
- an intervention group, which received play therapy involving a transport cart and toys; and
- a control group, which received anxiolytic medication and standard care.
Researchers compared the control group and the play therapy group to evaluate differences in anxiety levels using the Visual Analog Scale for Parents (VAS-P) and the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF).
Read the detailed description
Design and Study Population:
A randomized controlled clinical trial with parallel groups was conducted involving pediatric patients aged 3 to 6 years who were scheduled for inguinal hernia repair at Dr. Juan I. Menchaca Civil Hospital in Guadalajara, Mexico. Participants were randomly assigned to one of two groups: the play therapy group or the control group.
The play therapy group received a play-based intervention using toys. After five minutes of playing with a transport cart, the children were transported to the operating room in the same cart.
The control group received oral midazolam (0.1 mg/kg). After five minutes, they were transferred to the operating room either in a caregiver's arms or on a standard stretcher.
The study was approved by the Ethics and Research Committees (60/HCJIM-JAL/2023).
Assessment and Management of Anxiety:
Perioperative anxiety was assessed using two instruments:
The Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF), completed by the anesthesiologist.
The Visual Analog Scale for Parents (VAS-P), which measured anxiety as perceived by the child's parent or guardian.Both instruments were applied at three time points:
- Upon initial contact with the anesthesiologist
- After the intervention (play-based or pharmacological)
- Upon arrival in the operating room Additionally, midazolam was administered as rescue therapy for any patient exhibiting significant anxiety (mYPAS-SF score > 30 following the intervention).
- Conditions
- Perioperative Anxiety
- Being tested
- Play therapy with transport cart
- Keywords
- Pediatric Surgery, Anxiety Assessment, Herniorrhaphy, Play Therapy, Perioperative Anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play therapy with transport cartBehavioural
he intervention consisted of allowing pediatric patients to engage in five minutes of play with a toy transport cart, after which they were transported to the operating room in the same cart.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL / STANDARD CARE | No intervention | This group received standard care, including oral midazolam (0.1 mg/kg) as an anxiolytic before surgery. |
| Play Therapy With Transport Cart | Experimental | This group received a play-based intervention consisting of five minutes of play with a toy transport cart, after which the child was transported to the operating room using the same cart. Receives: Behavioral: Play therapy with transport cart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Assessment of Child Anxiety Levels
The child's anxiety levels were assessed by their parent or legal guardian using the Visual Analog Anxiety Scale for Parents (VAS-P). Baseline anxiety was measured at the first contact with the anesthesiologist. The VAS-P is a 10 cm horizontal scale, where values greater than 5 cm indicate significant anxiety.
Measured: Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).
Anesthesiologist Assessment of Child Anxiety Levels
The child's anxiety levels were assessed by the anesthesiologist using the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). Baseline anxiety was recorded at the first contact with the anesthesiologist. The mYPAS-SF provides scores ranging from 22.9 to 100 points, with values greater than 30 indicating the presence of significant anxiety.
Measured: Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start19 Jan 2023
- Primary completion23 Jul 2023
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERIKA MARTINEZ-LOPEZ, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868420
- Sponsor's protocol ID
- PL4Y-2024
- Status last verified
- Apr 2024
- First submitted
- 19 Feb 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Play Therapy for the Reduction of Perioperative Anxiety in Pediatric Patients Aged 3 to 6 Years Undergoing Inguinal Hernioplasty
- ClinicalTrials.gov ID
- NCT06868420
- Acronym / sponsor ID
- PL4Y-2024
- Conditions
- Perioperative Anxiety
- Keywords
- Pediatric Surgery, Anxiety Assessment, Herniorrhaphy, Play Therapy, Perioperative Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 23 Jul 2023 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 11 Mar 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 goal of this randomized controlled clinical trial was to determine the efficacy of play therapy in reducing perioperative anxiety in pediatric patients aged 3 to 6 years undergoing inguinal hernia surgery.
The main research question was:
Was play therapy effective in reducing perioperative anxiety levels in pediatric patients undergoing inguinal hernia repair?
Primary outcome measure: Anxiety level.
Patients were randomized into two groups:
- an intervention group, which received play therapy involving a transport cart and toys; and
- a control group, which received anxiolytic medication and standard care.
Researchers compared the control group and the play therapy group to evaluate differences in anxiety levels using the Visual Analog Scale for Parents (VAS-P) and the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF).
Detailed description
Design and Study Population:
A randomized controlled clinical trial with parallel groups was conducted involving pediatric patients aged 3 to 6 years who were scheduled for inguinal hernia repair at Dr. Juan I. Menchaca Civil Hospital in Guadalajara, Mexico. Participants were randomly assigned to one of two groups: the play therapy group or the control group.
The play therapy group received a play-based intervention using toys. After five minutes of playing with a transport cart, the children were transported to the operating room in the same cart.
The control group received oral midazolam (0.1 mg/kg). After five minutes, they were transferred to the operating room either in a caregiver's arms or on a standard stretcher.
The study was approved by the Ethics and Research Committees (60/HCJIM-JAL/2023).
Assessment and Management of Anxiety:
Perioperative anxiety was assessed using two instruments:
The Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF), completed by the anesthesiologist.
The Visual Analog Scale for Parents (VAS-P), which measured anxiety as perceived by the child's parent or guardian.Both instruments were applied at three time points:
- Upon initial contact with the anesthesiologist
- After the intervention (play-based or pharmacological)
- Upon arrival in the operating room Additionally, midazolam was administered as rescue therapy for any patient exhibiting significant anxiety (mYPAS-SF score > 30 following the intervention).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL / STANDARD CARE | No intervention | –This group received standard care, including oral midazolam (0.1 mg/kg) as an anxiolytic before surgery. |
| Play Therapy With Transport Cart | Experimental | Behavioral: Play therapy with transport cartThis group received a play-based intervention consisting of five minutes of play with a toy transport cart, after which the child was transported to the operating room using the same cart. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Pediatric patients aged 3 to 6 years.
- Patients of any sex.
- Patients scheduled for elective inguinal hernioplasty.
- Patients undergoing their first anesthetic-surgical procedure.
- Patients whose legal guardian provided informed consent.
Key exclusion criteria (3 listed)
- Patients with known allergy to midazolam.
- Patients with abnormal perinatal history (e.g., neonatal hypoxia or chromosomal abnormalities).
- Patients undergoing emergency inguinal hernioplasty due to complications such as strangulation or incarceration.
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 |
|---|---|---|
| Play therapy with transport carthe intervention consisted of allowing pediatric patients to engage in five minutes of play with a toy transport cart, after which they were transported to the operating room in the same cart. | Behavioural | Play Therapy With Transport Cart |
Primary outcome
Parental Assessment of Child Anxiety Levels
Time frame: Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).
The child's anxiety levels were assessed by their parent or legal guardian using the Visual Analog Anxiety Scale for Parents (VAS-P). Baseline anxiety was measured at the first contact with the anesthesiologist. The VAS-P is a 10 cm horizontal scale, where values greater than 5 cm indicate significant anxiety.
Anesthesiologist Assessment of Child Anxiety Levels
Time frame: Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).
The child's anxiety levels were assessed by the anesthesiologist using the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). Baseline anxiety was recorded at the first contact with the anesthesiologist. The mYPAS-SF provides scores ranging from 22.9 to 100 points, with values greater than 30 indicating the presence of significant anxiety.
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 15 Apr 2025.
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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?
A study testing Play therapy with transport cart in people with Perioperative Anxiety, run by University of Guadalajara at 1 site in Mexico.
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 5 inclusion and 3 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 15 Apr 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 Mexico. 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?
Parental Assessment of Child Anxiety Levels (time frame: Baseline (pre-intervention), 5 minutes after the intervention (post-intervention), and 1 hour after the intervention (final assessment).). The study lists 2 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 15 Apr 2025.