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OpenTrials
Completed

NCT Number: NCT03100487

Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders

The purpose of this study is to:

1. Determine if audio recorded guided imagery vs deep breathing exercises delivered via a digital media player improves abdominal pain symptoms in children with functional gastrointestinal pain disorders managed in the primary care setting. 2. Determine if audio recorded guided imagery and deep breathing exercises delivered via a digital media player improves psychosocial distress in children affected by functional gastrointestinal pain disorders managed in the primary care setting.

The possibility of treating functional gastrointestinal pain disorders using remotely delivered psychosocial therapies has the potential to treat many children affected by functional gastrointestinal pain disorders in a cost-effective manner. This study will provide insight into how well these patients in the primary care could benefit from such interventions.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

About this study

Children managed in primary care with a functional gastrointestinal pain disorder will be recruited and studied for this trial. After participants are deemed eligible, they will complete multiple questionnaires and then be randomly assigned (like a flip of a coin) to either guided imagery or deep breathing exercises delivered via a digital media player. Participants will be instructed to listen to the tracks at least 5 days per week for an 8 week intervention period.

At week 3 of the intervention period, the participant will complete another 2 week pain and stool diary.

At week 7 of the intervention period, the participant will complete another 2 week pain and stool dairy. After this diary is completed, the participant will again complete multiple questionnaires for their final visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children who meet criteria for a functional gastrointestinal pain disorder.
  • Children who manage their abdominal pain in the primary care setting.

Exclusion criteria

  • Children who have other comorbidities that are associated with chronic abdominal pain including abdominal surgery and other medical diagnoses that can cause chronic abdominal pain.
  • Children with an intellectual disability which would hamper their ability to communicate with study staff about their pain and complete study questionnaires.
  • Children who have presented to a gastroenterologist for abdominal pain management
  • Children who have previously used deep breathing exercises or guided imagery to manage their abdominal pain.

Treatment and study plan

Apple iPod Shuffle

Device

One session at least 5 days a week for a total of 8 weeks

Primary outcomes

  1. Change in abdominal pain symptoms

    Time frame: Change from Baseline to 8 weeks post-treatment

    Abdominal Pain Index

Secondary outcomes

  1. Improvement in health-related quality of life

    Time frame: Change from Baseline to 8 weeks post-treatment

    Pediatric Quality of Life Inventory (Peds QL) Questionnaire

  2. Change in Psychosocial Distress

    Time frame: Change from Baseline to 8 weeks post-treatment

    Behavior Assessment System for Children (BASC 3) Questionnaire

  3. Adherence to Intervention

    Time frame: 8 weeks after treatment

    Count of Number of Sessions Played

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

Efficacy of Remote Audio Recorded Guided Imagery vs Deep Breathing Exercises on Primary Pediatric Care Patients With Functional Gastrointestinal Pain Disorders (TCH Pediatric Pilot Award)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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