Procedural Pain in Children: Intervention With the Hospital Clown

Status Completed

Clinical Trial Summary

This study evaluates the effect of an intervention with a hospital clown compared to standard care on pain experience for acute hospitalized children receiving venipuncture. Half of the children will receive an intervention with the hospital clown while the other half will receive standard care.

Clinical Trial Description

Background: Hospitalized children describe the pain associated with painful procedures as one of the worst experiences during hospitalization. These experiences can be traumatic for children and their families. Most children are acutely hospitalized with no chance to prepare the child for painful procedures, while others experience repeated hospitalizations. Previous negative pain experiences are known to have major consequences for future admissions and procedures. Therefore, there is a need for different interventions for pain relief. In 2004, hospital clowns became a part of the team on pediatric wards in Denmark. International studies have shown positive effects of hospital clowns on preoperative anxiety in children, but there is limited knowledge of the impact on the child's experience related to painful procedures.

The overall purpose of this study is to investigate the effect and impact of the hospital clown as a non-pharmacological intervention on hospitalized children's pain experience and ability to cope during painful procedures in both short and long-term treatment and care.

Methods: A two-faced mixed methods study design with merging and connecting results and findings.

1. A prospective, randomized open-label trial to identify whether exposure to the hospital clown has an effect on pain experience in acute hospitalized children receiving venipuncture.

2. An ethnographic study to uncover the pain experience and ability to cope during painful procedures in short-term hospitalization.

3. An ethnographic study to uncover the influence related to repeated painful procedures, as well as uncover if a relationship may have a potential long-term impact. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03366623
Study type	Interventional
Source	Aalborg Universitetshospital
Contact
Status	Completed
Phase	N/A
Start date	April 18, 2016
Completion date	January 18, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05396820` - Adaptation of the Motor System to Experimental Pain	N/A
Completed	`NCT04356963` - Adjunct VR Pain Management in Acute Brain Injury	N/A
Recruiting	`NCT06350084` - Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection	N/A
Completed	`NCT04080037` - Assessing Opioid Care Practices Using CPV Patient Simulation Modules	N/A
Recruiting	`NCT05458037` - RCT of Pain Perception With Fast and Slow Tenaculum Application	N/A
Completed	`NCT04571515` - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain	Phase 2
Completed	`NCT06005480` - Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers	Phase 1
Active, not recruiting	`NCT04850079` - EHR Precision Drug Treatment in Neonates
Completed	`NCT03271151` - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty	Phase 4
Completed	`NCT03272139` - Interscalene Block Versus Superior Trunk Block	Phase 4
Recruiting	`NCT05383820` - Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment	Phase 4
Completed	`NCT04851353` - Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures	N/A
Completed	`NCT03280017` - Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain	Phase 4
Completed	`NCT04280796` - Changes in Affective Pain Processing in Human Volunteers	N/A
Not yet recruiting	`NCT04523623` - Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries	N/A
Not yet recruiting	`NCT04491630` - COping With PAin Through Hypnosis, Mindfulness and Spirituality	N/A
Not yet recruiting	`NCT04062513` - Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response	N/A
Withdrawn	`NCT03137030` - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults	Phase 1
Withdrawn	`NCT03137017` - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults	Phase 1
Completed	`NCT04659395` - How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.