Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653647
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Efficacy of Guided Imagery Therapy Mobile Application for Functional Abdominal Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Efficacy of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic abdominal pain is common among children and the majority of cases are attributed to functional abdominal pain disorders One approach to treating these disorders is by using psychological therapies This clinical trial aims to see how well pre-recorded guided imagery therapy sessions help childrens abdominal pain when delivered via a mobile application app on a smartphone or tablet
Participants will complete a baseline abdominal pain and stooling diary to determine eligibility and other surveys Participants who qualify will be placed in one of two groups by chance
Immediate Treatment Group
Delayed Treatment Group
After randomization the Immediate Treatment Group will get immediate access to the guided imagery therapy GIT mobile app intervention This intervention asks participants to listen to a 10- to 15-minute GIT session 5 out 7 days weekly for 8 weeks Then participants will complete another abdominal pain and stooling diary and other psychometric surveys at the end of this intervention period
After randomization the Delayed Treatment group will be observed as they wait 8 weeks without app access After the end of this waiting period participants will complete another abdominal pain and stooling diary and psychometric surveys again before gaining access to the GIT mobile app intervention As noted previously the mobile app intervention will ask participants to listen to a 10- to 15-minute GIT session 5 out of 7 days weekly for 8 weeks Another abdominal pain and stooling diary and other psychometric surveys will be collected at the end of this app intervention
Participants will complete a baseline abdominal pain and stooling diary to determine eligibility and other surveys Participants who qualify will be placed in one of two groups by chance
Immediate Treatment Group
Delayed Treatment Group
After randomization the Immediate Treatment Group will get immediate access to the guided imagery therapy GIT mobile app intervention This intervention asks participants to listen to a 10- to 15-minute GIT session 5 out 7 days weekly for 8 weeks Then participants will complete another abdominal pain and stooling diary and other psychometric surveys at the end of this intervention period
After randomization the Delayed Treatment group will be observed as they wait 8 weeks without app access After the end of this waiting period participants will complete another abdominal pain and stooling diary and psychometric surveys again before gaining access to the GIT mobile app intervention As noted previously the mobile app intervention will ask participants to listen to a 10- to 15-minute GIT session 5 out of 7 days weekly for 8 weeks Another abdominal pain and stooling diary and other psychometric surveys will be collected at the end of this app intervention
Detailed Description:
After fully disclosing the study design intervention options randomization scheme and potential side effects of the interventions caregivers and their children will document their respective informed consent and assent electronically REDCap is a secure web application designed for surveys and databases All data captured through REDCap will be encrypted and transmitted securely to HIPAA-compliant institutional servers for storage
Participants and their caregivers will complete the following surveys at baseline second baseline phase delayed treatment group only 8 weeks after baseline and immediately post-therapy delayed treatment group 16 weeks after baseline and immediate treatment group 8 weeks after baseline through REDCap
2-week Abdominal Pain and Stooling Diary
Childrens Somatic Symptoms Inventory child self-report and parent proxy-report
Pain Catastrophizing Scale - Child Version
Pain Catastrophizing Scale - Parent Version
Pediatric Quality of Life Inventory 40 Generic Core child self-report and parent proxy-report
Behavior Assessment System for Children 3rd Ed child self-report and parent proxy-report
Participants and their caregivers will complete the following surveys at baseline second baseline phase delayed treatment group only 8 weeks after baseline and immediately post-therapy delayed treatment group 16 weeks after baseline and immediate treatment group 8 weeks after baseline through REDCap
2-week Abdominal Pain and Stooling Diary
Childrens Somatic Symptoms Inventory child self-report and parent proxy-report
Pain Catastrophizing Scale - Child Version
Pain Catastrophizing Scale - Parent Version
Pediatric Quality of Life Inventory 40 Generic Core child self-report and parent proxy-report
Behavior Assessment System for Children 3rd Ed child self-report and parent proxy-report
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None