The Use of Therapeutic Clown in Painful Procedures in Children

NCT03122015 | Unknown

• 1 other identifier: 2017-1398
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children in hospitals are frequently subjected to painful procedures, including those involving needles, which are a common source of pain in children. In addition, procedural pain and anxiety can lead to various consequences for the child, as well for the parent and the nurse performing the procedure. The use of physical and psychological interventions is recommended for optimal relief of procedural pain. Moreover, these interventions can be used alone or in combination with pharmacological treatment. Although several analgesics exist and are used in clinical practice, nonpharmacological interventions aimed at the psychological component of pain are not well known and are not always used by the nurses in the pediatric practice. Distracting interventions are widely studied in the literature as it is an effective psychological intervention in the relief of pain and anxiety in children during needle-related pain procedures. The distraction by the therapeutic clown is a multi-modal intervention with multi-sensory effects and appears promising in pain relief and procedural anxiety, but not much studies have been done in the context above. The therapeutic clown can adapt to the age of the child, its culture, its reality of care and can prepare the child for painful procedures. The aim of this study is to assess the feasibility, acceptability and preliminary effects of distraction by therapeutic clown on pain and anxiety of children aged two to 17 years and the level of anxiety of the parents and nurses during a painful procedure in children. OBJECTIFS AND QUESTIONS:

1. 1.Assess the feasibility and acceptability of distraction by therapeutic clown with children during painful procedures. a) Is the distraction intervention by the therapeutic clown feasible and acceptable during painful procedures?
2. 2.Assess the preliminary effects of distraction by therapeutic clown on pain and anxiety of children and the anxiety of parents and nurses. a) What are the preliminary effects of the therapy clown distraction on children's pain and anxiety, and the anxiety of parents and nurse.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Acceptability

  Acceptability will be assessed with parents and nurses using a satisfaction survey. The survey will be provided to parents in paper form and will be verbally completed by the nurse. In addition, to document the feasibility and acceptability of the study, the number of children participating, as well as the duration of the procedure and the number of professionals involved will be noted throughout the procedure.

  T3 (immediately after the procedure before leaving the treatment room)

Secondary Outcomes (2)

• Pain intensity

  T2 (during the immunization procedure)

• Anxiety Level

  T1 (baseline), T2 (during the procedure).

Study Arms (2)

Therapeutic clown distraction

EXPERIMENTAL

The child will interact with the therapeutic clown throughout the painful procedure. The types of distraction interventions will be determined by the clown according to the child's age, culture and behavior. The clown can use different distraction activities such as magic, humor, visualization and play. According to various writings, the presence of the clown before the procedure varied between two to 20 minutes. In our study, the presence of the clown with parents and children will be about 10 minutes before the procedure and while the nurse performs the procedure until the child leaves the room. The distraction performed by a therapeutic clown is used in St. Justine' Hospital. Indeed, a team of therapeutic clowns is present in the hospital four times a week to distract the children. However, this procedure is not applied routinely in painful procedures and no study has evaluated its usefulness or effect.

Other: Therapeutic clown distraction

Standard care

NO INTERVENTION

Interventions

Therapeutic clown distraction OTHER

The presence of the therapeutic clown, which can adapt his interventions of distraction to the state of health of the patient and the culture of the child, is a multimodal and multi sensorial distraction intervention and can have an impact on health status, procedures, family and multidisciplinary team members. The results of five studies evaluated the effects of distraction by the clown therapy demonstrate a decrease in pain and anxiety in children aged 2 to 17 years, as well as parental anxiety in painful procedures involving needles such as venipuncture.

Therapeutic clown distraction

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children requiring immunization.
• Understand and speak French or who are accompanied by someone who understands and speaks french.
• Children accompanied by at least one parent.

You may not qualify if:

• Children afraid of clowns
• Children diagnosed with a mental, physical or visual impairment.

Sponsors & Collaborators

• St. Justine's Hospital: lead

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered nurse, Master's degree student

Model Details: This pilot study will include a group that will receive the intervention of distraction by the therapeutic clown (CT) and the other that will receive the standard treatment. The study will take place at St. Justine's Hospital, precisely at the infectious diseases clinic. Recruitment of participants will be by convenience from parents and children who will be eligible for study. The sample of this pilot project will contain approximately 24 children in addition to parents and the nurse who will perform the painful procedure.

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 20, 2017
• Study Start: April 30, 2017
• Primary Completion: June 30, 2017
• Study Completion: August 31, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share