- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07699341
Training on the Heimlich Maneuver for Mothers of Children With Disabilities
9 luglio 2026 aggiornato da: Emel AVÇİN, University of Yalova
For a Safe Breath: Training on the Heimlich Maneuver for Mothers of Children With Disabilities in Cases of Foreign Body Obstruction
Foreign body obstruction is one of the most common causes of medical emergencies, particularly in childhood, and can lead to fatal outcomes if not treated promptly and correctly.
Therefore, this study aims to examine the effect of hands-on Heimlich maneuver training for mothers of children with disabilities on the mothers' knowledge, skills, self-efficacy, and anxiety levels.
Conducted as a randomized controlled trial, the study is planned to include 70 mothers (experimental group: 35, control group: 35) of children aged 1-8 years attending a private rehabilitation center in the Besni district of Adıyaman.
Data collection tools will consist of a demographic information form, a Heimlich maneuver knowledge and skill test, and self-efficacy and anxiety scales.
A pilot study will be conducted to evaluate the validity and reliability of the data collection tools, test their comprehensibility for the mothers, and identify potential problems that may arise during implementation.
Prior to the start of the training, the knowledge levels of all mothers will be assessed via a questionnaire.
The Heimlich maneuver training provided to mothers in the experimental group will be delivered hands-on using a pediatric Heimlich mannequin.
One month after the training, a post-test will be administered to the mothers.
Mothers in the control group will be informed about the study during the initial interview and will take a pre-test.
One month after the training, the mothers will take the post-test.
Mothers in the control group will be informed about the study during the initial interview and will take the pre-test.
The post-test will be administered one month later, after which the mothers in this group will also receive maneuver training.
The mothers' pre-test and post-test scores will be compared both within and between groups.
Panoramica dello studio
Stato
Reclutamento
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
70
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: EMEL AVÇİN, Assist Prof
- Numero di telefono: 05534524243
- Email: emel.avcin@hotmail.com
Luoghi di studio
-
-
-
Adıyaman, Turchia (Türkiye), 02400
- Reclutamento
- Emel Avçin
-
Contatto:
- Ali Tekin
- Numero di telefono: 05534524243
- Email: emel.avcin@hotmail.com
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- Be a mother of a child with a disability, aged 1-8, who is enrolled in a rehabilitation center.
- Be 18 years of age or older.
- Be able to read and understand the research protocol, provide written informed consent, and agree to participate.
- Be physically able to participate in the training (standing/model-based exercises).
Exclusion Criteria:
- Must have previously received professional Heimlich maneuver/first aid training (those who have taken a course within the last 2 years).
- Those who are unable to participate in hands-on training due to physical limitations (e.g., severe heart disease, mobility issues).
- Individuals determined to be unsuitable for training or assessments due to psychiatric or neurological conditions.
- Children with severe respiratory system disorders (e.g., tracheostomy, severe bronchopulmonary dysplasia),
- Children who have undergone heart surgery or have a serious cardiac anomaly,
- Children with severe orthopedic or neurological disabilities for whom performing the Heimlich maneuver may be risky,
- Children with congenital anomalies of the trachea or upper respiratory tract (e.g., tracheoesophageal fistula),
- Children requiring mechanical ventilator support or continuous oxygen therapy.
- Withdrawing from participation during the study or failing to attend any of the training/testing sessions.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: intervention group
Mothers in the experimental group will receive training on how to perform the Heimlich maneuver for foreign-body obstruction in children with disabilities.
The training will include theoretical instruction and hands-on demonstrations using a mannequin.
Each mother will first receive theoretical and practical instruction, then be asked to perform the maneuver, and her performance will be evaluated through a skills test.
She will continue practicing until she performs the maneuver correctly.
Training will be provided one-on-one to each mother in a room assigned by the institution, lasting an average of 30-45 minutes.
A visually supported informational guide will be shared via cell phone so that mothers can refer to it as needed.
The practical steps in this training are based on the first aid guidelines of the American Academy of Pediatrics and the Ministry of Health of the Republic of Turkey.
The Heimlich Maneuver for children covers children aged 1-8 years (APA, 2017).
|
The Heimlich Maneuver training materials were prepared based on the first aid guidelines of the American Academy of Pediatrics and the Ministry of Health of the Republic of Turkey.
A guide supported by visuals was also prepared to serve as a reminder.
The training was demonstrated hands-on using a mannequin, and participants then practiced the technique under the supervision of a parent.
|
|
Nessun intervento: Control group
Mothers in the control group do not receive the training provided to the experimental group.
However, these mothers are asked not to receive any external Heimlich Maneuver training during the study period.
Once all data collection and analysis processes are complete, mothers in the control group will also receive the same high-quality Heimlich Maneuver training free of charge.
A visually supported informational guide will be shared via cell phone so that mothers can refer to it when needed.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Heimlich Knowledge Test
Lasso di tempo: Baseline, Week 4, and Week 8
|
Parental first aid knowledge was assessed using a researcher-developed 12-item multiple-choice knowledge test.
The test includes questions on recognition of foreign body obstruction, correct first aid steps, calling for emergency assistance, and age-group-specific application knowledge.
Each correct answer was scored as 1 point and incorrect answers as 0 points.
Total scores range from 0 to 12, with higher scores indicating better first aid knowledge.
|
Baseline, Week 4, and Week 8
|
|
Parental Self-Efficacy Scale
Lasso di tempo: Baseline, Week 4, and Week 8
|
Parental self-efficacy was assessed using the Parental Self-Efficacy Scale.
The scale consists of 17 items rated on a 7-point Likert scale.
Total scores range from 17 to 119, with higher scores indicating higher parental self-efficacy.
|
Baseline, Week 4, and Week 8
|
|
Beck Anxiety Inventory Score
Lasso di tempo: Baseline, Week 4, and Week 8
|
Anxiety symptoms were assessed using the Beck Anxiety Inventory.
The scale consists of 21 items rated on a 4-point Likert scale.
Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 63.
Higher total scores indicate greater severity of anxiety symptoms.
|
Baseline, Week 4, and Week 8
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: EMEL AVÇİN, Assist Prof, Adiyaman University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 giugno 2016
Completamento primario (Stimato)
30 settembre 2026
Completamento dello studio (Stimato)
30 novembre 2026
Date di iscrizione allo studio
Primo inviato
4 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
9 luglio 2026
Primo Inserito (Effettivo)
13 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Heimlich Ma.
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Individual participant data (IPD) will not be shared.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Heimlich Maneuver training
-
Cansu POLAT DÜNYAIstanbul University Scientific Research Projects Coordination Unit- PendingNon ancora reclutamentoDolore | Fallimento dell'accesso all'emodialisi | Fistola arterovenosa | Complicanze del dispositivo di accesso vascolare
-
Ricardo A Gutierrez Ramirez, MD, MSc, FACOGCompletatoMaturazione cervicale | Parto cesareo | Lavoro di fase latenteHonduras
-
Riphah International UniversityReclutamentoDiastasi dei muscoli rettiPakistan
-
University of CalgaryCanadian Association of Emergency PhysiciansCompletatoOstruzione delle vie aeree | SoffocamentoCanada
-
University of CalgaryReclutamentoOstruzione delle Vie Aeree da Corpo EstraneoCanada
-
University of CalgaryReclutamentoOstruzione delle Vie Aeree da Corpo EstraneoCanada
-
Stanford UniversityCompletatoSindrome da deficit di attenzione e iperattivitàStati Uniti
-
Nottingham University Hospitals NHS TrustCompletato
-
Mustafa Kemal UniversityCompletato
-
KTO Karatay UniversityCompletatoIctus | Riabilitazione dell'ictusTacchino