- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07577024
The Effect of Laughter Yoga on Preoperative Anxiety in Pediatric Patients
18. maj 2026 opdateret af: Saglik Bilimleri Universitesi
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ankara, Tyrkiet (Türkiye)
- Etlik City Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Intervention Group
The group receiving laughter therapy.
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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.
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Ingen indgriben: Control Group
The group receiving routine services.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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pre-operative anxiety
Tidsramme: First arrival at the preoperative area, 10 minutes after laughter yoga.
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modified Yale Preoperative Anxiety Scale (mYPAS scale) will be applied.
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First arrival at the preoperative area, 10 minutes after laughter yoga.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2026
Primær færdiggørelse (Faktiske)
28. februar 2026
Studieafslutning (Faktiske)
28. februar 2026
Datoer for studieregistrering
Først indsendt
13. april 2026
Først indsendt, der opfyldte QC-kriterier
5. maj 2026
Først opslået (Faktiske)
11. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. maj 2026
Sidst verificeret
1. oktober 2025
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-515
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Data are available from the corresponding author upon reasonable request
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