Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405799797673 Date of Approval: 08/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Three Multi- Sensory Stimulation Modalities on Needle-Related Procedural Pain, fear and Anxiety among children
Official scientific title Effect of Three Multi- Sensory Stimulation Modalities on Needle-Related Procedural Pain, fear and Anxiety among children
Brief summary describing the background and objectives of the trial Effective distraction, active emotional involvement and children’s participation require multisensory modalities, including visual, aural, and kinesthetic, to compete with unpleasant stimuli such as virtual reality. Additionally, the use of thermomechanical stimulation and kaleidoscopes can decrease pain perception and anxiety levels associated with needle procedures for children The current study aims to evaluate the effect of virtual reality, thermomechanical stimulation, and kaleidoscope on needle-related procedural pain and distress in children: - Assessing needle-related procedural pain and distress in school children. - Determining the effect of virtual reality, thermomechanical stimulation (Buzzy) and kaleidoscope on needle-related procedural pain and distress in preschool children and its effect on their physiological parameters.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied non pharmachological pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/02/2024
Actual trial start date 05/02/2024
Anticipated date of last follow up 01/07/2024
Actual Last follow-up date 17/05/2024
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants) 160
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Virtual Reality before and during the procedure related pain 6 months virtual reality group: The child will be asked to wear three-dimensional vision eye goggles to watch three-dimensional games before time of procedure and during procedure the researchers will measure intensity of pain, 40
Control Group control group routine care as talking, supporting the child during and after the procedure related pain control group 40 Placebo
Experimental Group kaleidoscope during and after the procedure during and after the procedure a toy through which various shapes and colors observed when looked in with one eye while rotating one of the cylinders. It contains various colored beads between broken mirrors adjacent to each other. As it is turned over the level of the eye, beads move and combine the appearances in the mirrors. Thus, various appealing designs are formed and observed. When a kaleidoscope is turned, designs vary according to the movement of beads and the same design rarely occurs. Hence, in each turn, different designs strike children’s interest that achieve the needed distraction of attention during the invasive procedure 40
Experimental Group Thermomechanical stimulation during and after procedure during and after procedure group (2)Thermomechanical stimulation( Buzzy bee )group: The researcher freezes the ice wings for 10 minutes before starting the procedure, wiped the buzzy with 70% alcohol before used, connect the ice wings with the buzzy vibration. Children in the Buzzy group and their parents were shown the “Buzzy” tool and informed that it will be placed on the child's arm during the procedure. 30–60 s before the procedure, “Buzzy” and ice packs are placed on the child's arm to be treated, while the vibration feature is activated. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 6-10 years underwent needle-related procedures Blood Sampling - IV Puncture - IV Canulation. All children are free from mental disability to be able to interact with the research if needed. Children with peripheral vascular disease, connective tissue disease, diabetic neuropathy, chronic illness or birth defects, central nervous system disease, visual and hearing impairment, and altered level of consciousness Child: 6 Year-12 Year 6 Year(s) 10 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/11/2023 Scientific Research ethics committee faculty of nursing
Ethics Committee Address
Street address City Postal code Country
Elgeish street tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome physiological parameters of children, Wong-Baker Faces Pain Rating Scale, The Children’s Fear Scale, The Children’s Anxiety Meter score after procedure
Primary Outcome Wong-Baker Faces Pain Rating Scale after invasive procedure
Secondary Outcome The Children’s Fear Scale and The Children’s Anxiety Meter after procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta Main University Hospital Elgeish street tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
seham Eid makaa street tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of nursing Elgeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Samia Hegazy elmotasem Kafr Elsheigh Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seham Elhalafawy seham.elhalafawi@nursing.tanta.edu.eg 00201018787624 Makah street
City Postal code Country Position/Affiliation
tanta Egypt Lecturer of pediatric nursing
Role Name Email Phone Street address
Public Enquiries Ahmed bakr ahmed.bakr717@yahoo.com 00201098547169 bresha street
City Postal code Country Position/Affiliation
tanta Egypt acountant
Role Name Email Phone Street address
Scientific Enquiries samar eldesoky samar_eldesoky@nursing.tanta.edu.eg 00201553238428 elmehala
City Postal code Country Position/Affiliation
elmehala Egypt lecturer of pediatric nursing
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. Informed Consent Form,Study Protocol Immediately following publication. No end date. controlled access after approval of authors
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information