NCT07699341

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jun 2016Nov 2026

Study Start

First participant enrolled

June 1, 2016

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

10.3 years

First QC Date

July 4, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

BreathForeign Body ObstructionDisabilitiesChildrenHeimlich Maneuver

Outcome Measures

Primary Outcomes (3)

  • Heimlich Knowledge Test

    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

    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

    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

Study Arms (2)

intervention group

EXPERIMENTAL

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).

Behavioral: Heimlich Maneuver training

Control group

NO INTERVENTION

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.

Interventions

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.

intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emel Avçin

Adıyaman, 02400, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Airway ObstructionRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • EMEL AVÇİN, Assist Prof

    Adiyaman University

    STUDY DIRECTOR

Central Study Contacts

EMEL AVÇİN, Assist Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study is a pre-test-post-test controlled group study with a randomized controlled design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass Prof

Study Record Dates

First Submitted

July 4, 2026

First Posted

July 13, 2026

Study Start

June 1, 2016

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared.

Locations