- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07699341
Training on the Heimlich Maneuver for Mothers of Children With Disabilities
9. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
70
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: EMEL AVÇİN, Assist Prof
- Telefonnummer: 05534524243
- E-Mail: emel.avcin@hotmail.com
Studienorte
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Adıyaman, Türkei (türkiye), 02400
- Rekrutierung
- Emel Avçin
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Kontakt:
- Ali Tekin
- Telefonnummer: 05534524243
- E-Mail: emel.avcin@hotmail.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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).
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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.
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Kein Eingriff: 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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Heimlich Knowledge Test
Zeitfenster: Baseline, Week 4, and Week 8
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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.
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Baseline, Week 4, and Week 8
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Parental Self-Efficacy Scale
Zeitfenster: Baseline, Week 4, and Week 8
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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.
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Baseline, Week 4, and Week 8
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Beck Anxiety Inventory Score
Zeitfenster: Baseline, Week 4, and Week 8
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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.
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Baseline, Week 4, and Week 8
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: EMEL AVÇİN, Assist Prof, Adiyaman University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juni 2016
Primärer Abschluss (Geschätzt)
30. September 2026
Studienabschluss (Geschätzt)
30. November 2026
Studienanmeldedaten
Zuerst eingereicht
4. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Juli 2026
Zuerst gepostet (Tatsächlich)
13. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Heimlich Ma.
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Individual participant data (IPD) will not be shared.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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