Pre-operative AnxietyNCT07577024
The Effect of Laughter Yoga on Preoperative Anxiety in Pediatric Patients
A study testing laughter therapy in people with Pre-operative Anxiety, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The effect of laughter yoga on a child's pre-operative anxiety. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-operative Anxiety
- What is being tested?
- laughter therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 28 Feb 2026
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Speaking Turkish
- Having American Society of Anesthesiologists (ASA) I and II certifications
- Planned as an elective operation
- Children aged 5-12 undergoing their first surgery
- Having no chronic illnesses
Who cannot join
- Children with accompanying chronic illnesses and/or psychological disorders
- Children with health problems that prevent them from doing laughter yoga (urinary incontinence, persistent cough, etc.)
- Parents and children who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laughter Yoga on Preoperative Anxiety in Pediatric Patients: A Randomized Controlled Study
The effect of laughter yoga on a child's pre-operative anxiety.
Read the detailed description
Children and their parents who meet the inclusion criteria will be informed about the study content; written informed consent will be obtained from the parents and verbal assent from the children prior to participation. The study will be conducted with two separate groups: a control group receiving routine preoperative care and an intervention group practicing laughter yoga. To ensure balance, groups will be formed using day randomization while considering age criteria. Prior to the study, the researcher completed a laughter yoga course and obtained an "Internationally Accredited Laughter Yoga Leadership Training" certificate. The nurse researcher administering the pre-tests and post-tests will be blinded to whether laughter yoga was applied to the groups. In the intervention group, children brought to the preoperative area one hour early (per routine) will receive a pre-test from the blinded nurse researcher, followed by a 30-minute laughter yoga session led by the researcher, and a post-test administered approximately 10 minutes thereafter. For the control group receiving routine care, the pre-test will be administered, and the post-test will be performed after a 30-minute waiting period.Surgical anxiety disorder was categorized according to the modified Yale Preoperative Anxiety Scale (m-YPAS )performance score out of 40, as stated in the report prepared by Hatipoğlu et al. (2019); scores above 40 were considered high anxiety, and scores below 40 were considered low anxiety. The minimum score that can be obtained is 22.9 and the maximum score is 100.
- Conditions
- Pre-operative Anxiety
- Being tested
- laughter therapy
- Keywords
- laughter yoga, children, pre-operative anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter therapyOther
Within the scope of the study, children in the intervention group-who are brought to the preoperative area one hour in advance as per routine practice-will be administered a pre-test by a blinded nurse researcher, followed by a laughter yoga session conducted by the researcher lasting approximately 30 minutes. To allow the physiological and psychological effects of the intervention to stabilize, the post-test will be administered 10 minutes after the session. In the control group receiving routine care without laughter yoga, the pre-test will be administered, and a post-test will be performed after a 40-minute waiting period to ensure consistency in the time criteria between the two groups.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The group receiving laughter therapy. Receives: Other: laughter therapy |
| Control Group | No intervention | The group receiving routine services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-operative anxiety
modified Yale Preoperative Anxiety Scale (mYPAS scale) will be applied.
Measured: First arrival at the preoperative area, 10 minutes after laughter yoga.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Jan 2026
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-operative AnxietyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577024
- Sponsor's protocol ID
- 2025-515
- Status last verified
- Oct 2025
- First submitted
- 13 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available from the corresponding author upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Preoperative Anxiety in Pediatric Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07577024
- Acronym / sponsor ID
- 2025-515
- Conditions
- Pre-operative Anxiety
- Keywords
- laughter yoga, children, pre-operative anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 11 May 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.
The effect of laughter yoga on a child's pre-operative anxiety.
Detailed description
Children and their parents who meet the inclusion criteria will be informed about the study content; written informed consent will be obtained from the parents and verbal assent from the children prior to participation. The study will be conducted with two separate groups: a control group receiving routine preoperative care and an intervention group practicing laughter yoga. To ensure balance, groups will be formed using day randomization while considering age criteria. Prior to the study, the researcher completed a laughter yoga course and obtained an "Internationally Accredited Laughter Yoga Leadership Training" certificate. The nurse researcher administering the pre-tests and post-tests will be blinded to whether laughter yoga was applied to the groups. In the intervention group, children brought to the preoperative area one hour early (per routine) will receive a pre-test from the blinded nurse researcher, followed by a 30-minute laughter yoga session led by the researcher, and a post-test administered approximately 10 minutes thereafter. For the control group receiving routine care, the pre-test will be administered, and the post-test will be performed after a 30-minute waiting period.Surgical anxiety disorder was categorized according to the modified Yale Preoperative Anxiety Scale (m-YPAS )performance score out of 40, as stated in the report prepared by Hatipoğlu et al. (2019); scores above 40 were considered high anxiety, and scores below 40 were considered low anxiety. The minimum score that can be obtained is 22.9 and the maximum score is 100.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: laughter therapyThe group receiving laughter therapy. |
| Control Group | No intervention | –The group receiving routine services. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Speaking Turkish
- Having American Society of Anesthesiologists (ASA) I and II certifications
- Planned as an elective operation
- Children aged 5-12 undergoing their first surgery
- Having no chronic illnesses
Key exclusion criteria (3 listed)
- Children with accompanying chronic illnesses and/or psychological disorders
- Children with health problems that prevent them from doing laughter yoga (urinary incontinence, persistent cough, etc.)
- Parents and children who refuse to participate in the study.
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 |
|---|---|---|
| laughter therapyWithin the scope of the study, children in the intervention group-who are brought to the preoperative area one hour in advance as per routine practice-will be administered a pre-test by a blinded nurse researcher, followed by a laughter yoga session conducted by the researcher lasting approximately 30 minutes. To allow the physiological and psychological effects of the intervention to stabilize, the post-test will be administered 10 minutes after the session. In the control group receiving routine care without laughter yoga, the pre-test will be administered, and a post-test will be performed after a 40-minute waiting period to ensure consistency in the time criteria between the two groups. | Other | Intervention Group |
Primary outcome
pre-operative anxiety
Time frame: First arrival at the preoperative area, 10 minutes after laughter yoga.
modified Yale Preoperative Anxiety Scale (mYPAS scale) will be applied.
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 22 May 2026.
- Individual participant dataSharing planned: No. Data are available from the corresponding author upon reasonable request
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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 laughter therapy in people with Pre-operative Anxiety, run by Saglik Bilimleri Universitesi 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 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 22 May 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?
pre-operative anxiety (time frame: First arrival at the preoperative area, 10 minutes after laughter yoga.). 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 22 May 2026.