Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT03004456
Brief Summary:
Children with chronic diseases, particularly those who have received transplantation (e.g. cardiac, renal, or liver) are a population who undergo frequent painful procedures, such as venipuncture multiple times per week. There is currently no standard of care for pain reduction during venipuncture for pediatric patients having blood drawn in phlebotomy as an outpatient. The study aims to determine the efficacy of distraction in reducing procedural pain and distress associated with venipuncture in pediatric post-transplant patients.
Detailed Description:
Children with chronic illnesses experience frequent painful experiences over extended periods of time, and may develop long-term physiological, psychological and behavioral sequelae including increased sensitivity to pain and higher levels of anxiety before painful procedures. There is strong evidence to show that distraction is effective in reducing children's pain and distress during painful procedures. However, the evidence to support distraction, as well as other methods of pain reduction during venipuncture (i.e. vibration, topical anesthetics, sucrose), has primarily focused on children who are previously well, as those with chronic disease are an understudied population with regards to pain reduction during simple procedures. Children with chronic disease or pathology, particularly those who have received transplantation (e.g. cardiac, renal, liver), are a population who undergo frequent painful procedures, such as venipuncture multiple times per week. There is currently no standard of care for pain reduction during venipuncture for pediatric patients having blood drawn in phlebotomy or in the transplant clinics as an outpatient.
The investigators will conduct a randomized control trial comparing two groups: Distraction versus standard of care (i.e. no distraction). The intervention (distraction) will be administered using an iPad and allowing the child to self-select a developmentally appropriate distraction (e.g. game, movie, music). Participants will be videotaped for approximately 1 minute, starting from the time of the venipuncture. This video will be viewed at a later date by two trained study investigators to assess the patient's pain and distress associated with venipuncture, as measured by the OSBD-r, CHEOPS, and FLACC.
Study:
NCT03004456
Study Brief:
Protocol Section:
NCT03004456