Clown Care for Botulinum Toxin (BTX)

Sponsor

Shaare Zedek Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01377883

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin (BTX) injections that are administered several times a year. While clown care reduces preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized that medical clowning reduces pain and anxiety during BTX injections.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy Pain	Other: standard Behavioral: clown care	N/A

Detailed Description

PATIENTS AND METHODS: Twenty five children with CP (mean age 7.4±4.8 years; 19 boys), enrolled in this randomized controlled study underwent BTX injections (3±1.7 muscles per procedure). Prior to treatment each child was assigned to receive either medical clown intervention (study) or standard care (control). Outcome measure was the Visual Analogue Scale (VAS) as reported by the child (n =14) or parent (n =11) prior and subsequent to each procedure.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Standard intervention Preparation and information: the doctor and nurse explained the steps of the procedure: placing EMG electrodes, wiping the area with an alcohol swab, cooling with ethyl chloride, needle insertion into the muscle and the importance of EMG noise. Memory change and positive reinforcement: medical staff present spoke to the child positively and offered prizes, among which the child could choose. Volunteer attendance: as part of the control session, receiving no particular instructions in relation to the child's potential pain during the procedure.	Other: standard Preparation and information regarding the BTX procedure: placing EMG electrodes, wiping the area with an alcohol swab, cooling with ethyl chloride, needle insertion into the muscle and the importance of EMG noise. Injection performed under EMG guidance. Two sites of injection per muscle were used to enhance diffusion. The child could often see the procedure when the upper limb was treated but not during lower limb injections. Memory change and positive reinforcement: Following the BTX injection, the medical staff present spoke to the child positively and offered prizes Volunteer attendance: In the daycare unit there are young volunteers routinely present, assisting with technical aspects of the procedure.
Experimental: clown care Cognitive coping: encouraging a child to cope with the challenge. Imagery: a cognitive technique used to encourage the child to cope with the pain and distress of the procedure by imagining a pleasant object or experience Empowerment: the child is made to feel empowered by controlling the actions of the clown Reflecting emotions: the clown, sensing the state of the child, plays it out in an exaggerated fashion.	Behavioral: clown care Cognitive coping Imagery Empowerment Reflecting emotions

Arm

Intervention/Treatment

Sham Comparator: Standard intervention

Preparation and information: the doctor and nurse explained the steps of the procedure: placing EMG electrodes, wiping the area with an alcohol swab, cooling with ethyl chloride, needle insertion into the muscle and the importance of EMG noise. Memory change and positive reinforcement: medical staff present spoke to the child positively and offered prizes, among which the child could choose. Volunteer attendance: as part of the control session, receiving no particular instructions in relation to the child's potential pain during the procedure.

Other: standard

Preparation and information regarding the BTX procedure: placing EMG electrodes, wiping the area with an alcohol swab, cooling with ethyl chloride, needle insertion into the muscle and the importance of EMG noise. Injection performed under EMG guidance. Two sites of injection per muscle were used to enhance diffusion. The child could often see the procedure when the upper limb was treated but not during lower limb injections. Memory change and positive reinforcement: Following the BTX injection, the medical staff present spoke to the child positively and offered prizes Volunteer attendance: In the daycare unit there are young volunteers routinely present, assisting with technical aspects of the procedure.

Experimental: clown care

Cognitive coping: encouraging a child to cope with the challenge. Imagery: a cognitive technique used to encourage the child to cope with the pain and distress of the procedure by imagining a pleasant object or experience Empowerment: the child is made to feel empowered by controlling the actions of the clown Reflecting emotions: the clown, sensing the state of the child, plays it out in an exaggerated fashion.

Behavioral: clown care

Cognitive coping Imagery Empowerment Reflecting emotions

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale [sevral minutes before and after BTX injections]
Visual Analogue Scale by the child before after BTX injection. Parent rated the pain if the child was younger than 5 years or cognitively impaired

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children with CP for whom BTX treatment was indicated

Exclusion Criteria:

Children with minimal communication skills (n =1)
Autistic spectrum disorders (n =1)
Severe anxiety requiring general anesthesia (n =1)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Hilla Ben-Pazi, PI, Shaare Zedek Medical Center

ClinicalTrials.gov Identifier:

NCT01377883

Other Study ID Numbers:

CL_BTX2011

First Posted:

Jun 22, 2011

Last Update Posted:

Dec 31, 2018

Last Verified:

Dec 1, 2018

Keywords provided by Dr. Hilla Ben-Pazi, PI, Shaare Zedek Medical Center

Needle, Anxiety, Pain, Clowns

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Dec 31, 2018