Methods of Providing Information Prior to an Alveolar Bone Graft

NCT04381078 | Unknown

• 1 other identifier: 18BA44
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Patients born with a cleft of the lip and/or palate may have a gap in the bone in the roof of their mouth and in the area of bone where the teeth develop. These patients require an alveolar bone graft (ABG) to allow the eruption of the maxillary canine teeth amongst other reasons. The optimal time to carry this out is between the ages of nine and eleven. Whilst the patients will have had interventions as infants, this is often the first procedure a child born with a cleft lip and/or palate is likely to comprehend. An audio-visual guide has been developed by the Great Ormond Street Hospital Dental Department for children undergoing an ABG. It explains the reason for the procedure, what the process will involve and advice regarding postoperative care. This study will try ascertain whether providing information to patients and parents in this manner reduces anxiety, improves understanding of why the procedure was undertaken and post-operative care. Children between the ages of eight and twelve ready for this procedure at Great Ormond Street Hospital will be enrolled. They will be allocated into two groups during their assessment appointment. The control will be given standardised verbal and written information, whilst the experimental group will also be given the animation. The level of anxiety and understanding of the procedure will be measured after the intervention/control information and once again when the patient attends for their pre-surgical assessment two to three months later. This study aims to see whether the patient and parent anxiety is reduced and knowledge regarding the procedure is improved when utilising this of kind audio-visual guide for children. This will indicate whether it is worthwhile committing resources to the development of similar animations for other procedures.

Conditions

Cleft Lip and Palate

Keywords

cleft lip and palate; audiovisual guides; alveolar bone graft; anxiety

Outcome Measures

Primary Outcomes (2)

• State Anxiety Section of State-Trait Anxiety Inventory for Children

  Validated measure of Child State Anxiety

  Change from baseline to immediately after intervention, an average of 30minutes

• State Anxiety Section of State-Trait Anxiety Inventory for Children

  Validated measure of Child State Anxiety

  Change from baseline to surgical pre-assessment appointment, an average of 3months

Secondary Outcomes (6)

• State Anxiety section of State-Trait Anxiety Inventory

  Change from baseline to immediately after intervention, an average of 30minutes

• State Anxiety section of State-Trait Anxiety Inventory

  Change from baseline to surgical pre-assessment appointment, an average of 3months

• Patient Questionnaire

  Change from baseline to immediately after intervention an average of 30minutes

• Patient Questionnaire

  Change from baseline to surgical pre-assessment appointment, an average of 3months

• Parent/Legal Guardian Questionnaire

  Change from baseline to immediately after intervention an average of 30minutes

Study Arms (2)

Intervention

EXPERIMENTAL

Standardised Verbal Instructions Standardised Written Instructions Audiovisual Guide

Other: ACE - AudioVisual Guide

Control

NO INTERVENTION

Standardised Verbal Instructions Standardised Written Instructions

Interventions

ACE - AudioVisual Guide OTHER

Audiovisual guide to Alveolar Bone Graft Procedure, Pre-surgical orthodontics and post-operative care

Intervention

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients between the age of eight and twelve
• With Cleft lip and/or palate requiring and ready for an alveolar bone graft
• Irrespective of gender.

You may not qualify if:

• Diagnosed Syndrome
• Identified global developmental delay
• Previous alveolar bone graft
• Patient and/or parent/guardian unable to read/understand English
• Declined to participate

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital

London, 020 7405 9200, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cleft Lip; Anxiety Disorders

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Central Study Contacts

Norman Hay, BDS FDS RCS

CONTACT

020 7405 9200; norman.hay@gosh.nhs.uk

Suhaym Mubeen, BDS (Hons) FDC RCS

CONTACT

020 7405 9200; suhaym.mubeen@gosh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: May 8, 2020
• Study Start: December 9, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)