Acute Pain Pain Management
Conditions
Interventions
It is a study that evaluates four groups with allocation defined by random sequence generation via Random computer software through opaque sealed and sequentially numbered envelopes and open label mas
in the Virtual Reality (VR) Intervention Group with 15 participants VR Shinecon brand glasses are used coupled to a Samsung A54 smartphone displaying three-dimensional video of the seabed and ocean so
in the Music Therapy Intervention Group with 15 participants the procedure occurs in a reserved room lasting 15 minutes before vaccination, conducted by a music therapist who uses active musical recep
in the Instructional Therapeutic Toy (BTI) Intervention Group with 15 participants the session lasts 15 minutes before vaccination and uses rag dolls and simulated materials such as syringes and vials
in the Control Group with 15 participants standard care is performed by nursing technicians consisting of verbal guidelines to parents and positioning the child on the lap in a vertical position witho
Sponsors
Universidade Estadual de Feira de Santana
Universidade Estadual de Feira de Santana
Eligibility
Age
4 Years to 6 Years
Inclusion criteria
Inclusion criteria: Age 4 to 6 years 11 months and 29 days. Both sexes. Child awake. Child accompanied by parents or legal guardian over 18 years of age capable of consenting and native Portuguese speaker. No analgesics or sedatives received in the 12 hours prior to enrollment. Indication for varicella vaccine
Exclusion criteria
Exclusion criteria: Fever = 37.5°C on the day. Undergone needle interventions on the same day. Diagnosed with cognitive deficit or any psychiatric condition such as autism depression or anxiety. Severe neurological conditions that alter behavioral assessment such as epilepsy cerebral palsy or seizures. Withdrawal by the guardian. Visual or hearing impairment. Oculomotor and convergence disorders such as strabismus or nystagmus. History of migraine or labyrinthitis. Head injuries preventing painless placement of VR glasses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be pain intensity measured by the self-report Faces Pain Scale-Revised (FPS-R) composed of six faces with scores from 0 to 10 being 0 no pain and 10 very much pain applied after the child stabilizes post-vaccination using the validated Portuguese version made available by the International Association for the Study of Pain (IASP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include feasibility analysis through eligibility and recruitment and retention and attrition and protocol fidelity and missing data and data loss rates as well as the satisfaction rate of the child and guardian and health professional involved in vaccination | — |
Countries
BR
Contacts
Public ContactValesca Correia
Universidade Estadual de Feira de Santana
Outcome results
None listed