Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized Evaluation of a Positioning Pillow for Lumbar Puncture in Paediatric Hematology-Oncology
Brief Summary: We have developed a positioning cushion for LP which allows the child to be relaxed in an adequate position, and to maintain this position throughout LP. This study was aimed at evaluating the benefit of the device on the technical quality of LPs, on pain, anxiety, post LP syndrome, and on the satisfaction of children, their parents and caregivers.

The study was a two-centre, open, randomized trial, with two parallel groups. Children aged 2 to 18 years undergoing a LP were eligible, if not included in the study before. Those who had used the cushion before, with a medical reason preventing the use of the cushion, those refusing or whose parents refused could not be included. Randomization was stratified by centre.

Four cushion sizes were available for the age ranges: 2-6 years, 6-10 years, 10-15 and 15-18 years. The primary outcome was the rate of success, defined as a LP reaching its objective at the first attempt, without hemorrhage (visible hemorrhage or RBC \> 50/mm3 in the CSF sample). Secondary outcomes included: the child's pain using a visual analogic scale (VAS), parents and caregiver perception of the child's pain (VAS); the children, parents, caregiver and physician performing the LP satisfaction; children cooperation using the "Le Baron Scale", and the occurrence of a post LP syndrome.


Options:
A: Arm Label: Group 1; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Educational Video - Sham, Drug: Sucrose Placebo (water), Drug: Lidocaine Placebo | Arm Label: Group 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Educational video - Active, Drug: Sucrose Placebo (water), Drug: Lidocaine Placebo | Arm Label: Group 3; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Educational video - Active, Drug: Sucrose, Drug: Lidocaine Placebo | Arm Label: Group 4; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Educational video - Active, Drug: Sucrose, Drug: Lidocaine | Intervention Type: BEHAVIORAL; Name: Educational video - Active; Assigned to Arm(s): Group 2, Group 3, Group 4 | Intervention Type: BEHAVIORAL; Name: Educational Video - Sham; Assigned to Arm(s): Group 1 | Intervention Type: DRUG; Name: Sucrose Placebo (water); Assigned to Arm(s): Group 1, Group 2 | Intervention Type: DRUG; Name: Sucrose; Assigned to Arm(s): Group 3, Group 4 | Intervention Type: DRUG; Name: Lidocaine Placebo; Assigned to Arm(s): Group 1, Group 2, Group 3 | Intervention Type: DRUG; Name: Lidocaine; Assigned to Arm(s): Group 4
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Device: pillow | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: pillow; Assigned to Arm(s): 1
C: Arm Label: Tactile stimulation; Type: EXPERIMENTAL; Interventions: Behavioral: Tactile stimulation | Arm Label: No tactile stimulation; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Tactile stimulation; Assigned to Arm(s): Tactile stimulation
D: Arm Label: 0.1ml 24% sucrose concurrent opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Arm Label: 0.5ml 24% sucrose concurrent opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Arm Label: 1.0ml 24% sucrose concurrent opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Arm Label: 0.1ml 24% sucrose no opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Arm Label: 0.5ml 24% sucrose no opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Arm Label: 1.0ml 24% sucrose no opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Intervention Type: OTHER; Name: sucrose; Assigned to Arm(s): 0.1ml 24% sucrose concurrent opioids, 0.1ml 24% sucrose no opioids, 0.5ml 24% sucrose concurrent opioids, 0.5ml 24% sucrose no opioids, 1.0ml 24% sucrose concurrent opioids, 1.0ml 24% sucrose no opioids

Answer: B