NCT07144982

Brief Summary

In a single-centre observational before-after study (n=31 parental smokers), a standardized \~15-minute tobacco-counselling intervention delivered during the paediatric ambulatory pathway significantly increased parental awareness of secondhand-smoke harms (median total score 34→46; p=0.0026). Item-level gains were greatest for perceived anaesthetic risk and misconceptions about tertiary/indirect exposure. Session acceptability was high, but self-reported behavioural change at 30 days was limited. The perioperative consultation is a feasible "teachable moment"; integration with visual aids, objective exposure measures, structured cessation referral and longitudinal follow-up should be considered to translate awareness into sustained exposure reduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 7, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 14, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

Tobacco Smoke PollutionChildSecondhand SmokingPatient EducationPerioperative Care

Outcome Measures

Primary Outcomes (1)

  • 60-points score parental awareness

    The primary outcome was change in parental awareness measured by a six-item questionnaire (each item scored 0-10; total range 0-60) administered at baseline (arrival), immediately after counselling, and at 30 days by telephone.

    4 hours

Secondary Outcomes (1)

  • Smoking changes

    30 days

Study Arms (1)

Provide additional information about the group or cohort, including a description of any interventio

Eligible participants were adult parents who declared current tobacco use and were present at their child's ambulatory surgical visit. Exclusions included parents absent on the day of surgery, procedures postponed, or explicit refusal to participate.

Behavioral: Counselling session

Interventions

Each enrolled parent received a single, standardized counselling session (\~15 minutes) delivered in the ambulatory unit by a certified tobacco counsellor. The session followed a fixed script and covered: (1) types of tobacco smoke exposure (primary, secondary and tertiary), (2) health consequences for children with emphasis on perioperative respiratory and anaesthetic risks, (3) practical measures to reduce household exposure (smoke-free home/car rules, behavioural strategies), and (4) brief advice on initial cessation steps and referral options. Structured handouts and signposting to support services were offered when appropriate.

Provide additional information about the group or cohort, including a description of any interventio

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Eligible participants were adult parents who declared current tobacco use and were present at their child's ambulatory surgical visit. Exclusions included parents absent on the day of surgery, procedures postponed, or explicit refusal to participate.

You may qualify if:

  • adult parents who declared current tobacco use and were present at their child's ambulatory surgical visit

You may not qualify if:

  • parents absent on the day of surgery
  • procedures postponed
  • explicit refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michele Carella

Liège, 4000, Belgium

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD ESRA-DRA

Study Record Dates

First Submitted

August 14, 2025

First Posted

August 28, 2025

Study Start

November 7, 2024

Primary Completion

March 27, 2025

Study Completion

March 27, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations