Objectives:

 • To evaluate the effect of VR on the pain score as determined by the Wong-Baker FACES Pain Rating Scale (WBS) among children aged 5-12 years undergoing needle procedures.

 • To evaluate the effect of VR on the fear score as determined by the Children’s Fear Scale (CFS) among children aged 5-12 years undergoing needle procedures. 

 • To evaluate the effect of VR on the anxiety score as determined by the State Anxiety Scale for Children (Short form) among children aged 5-12 years undergoing needle procedures. 

Methodology: 

 This study protocol describes the design of a parallel-group RCT (1:1 ratio) conducted at the primary and community health centers in and around Hyderabad. The study protocol abides by the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) while the RCT will comply to the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting RCTs. The ethical approval for the study will be taken from Institutional Ethics Committee and the study will be registered at Clinical Trials Registry India (CTRI). 

 Inclusion criteria 

 • Children aged 5-16 years attending OPD for consultation

 • Children aged 5-16 years attending primary and community health centers for needle procedures 

 Exclusion criteria: 

 • Children with severe illness 

 • Children with visual disturbances 

Study Tools: 

 Wong Baker FACES Pain Rating Scale (WBS): This scale is used to evaluate pain on children aged 3 years and older. The WBS consists of 5 faces and is graded from 0-10 (left to right), where the smiling face represents 0 (no hurt) and the crying face represents 10 (hurts worst). Participants will be asked to point to the face that most accurately shows how much pain they felt during the procedure (14,15). 

 Children’s Fear Scale (CFS): The CFS measures pain related fear in children. It is a one-item scale that consists of 5 faces graded from 0-4 (left to right). The face graded 0 shows no fear and the face graded 4 shows significant fear. The participant will be asked to point to the face that most accurately represents how much fear they are feeling before and after the procedure (16). 

 State Anxiety Scale for Children (Short form): The State Anxiety Scale for Children (SAS-C) is a scale used to determine the state anxiety in children. It consists of 10 questions that the participant is asked to fill out. The answers are graded 1-3 and the total scores range from 10-30, where a higher number indicates higher anxiety. The participant will be asked to fill out the form before and after the procedure (17). 

Recruitment Procedure: 

 Children aged 5-16 years attending the OPD or admitted to the in-patient wards in the primary and community health centers in and around Hyderabad who are scheduled to undergo a needle procedure such as immunization, intramuscular and intravenous injections/ cannulations, and but not limited to blood tests will be asked to participate in the study. If willing, written informed assent will be taken from their parents/guardians. 

Randomization procedure and concealment of allocation: 

 Patients fulfilling eligibility criteria and willing to participate will be randomized into two groups after baseline assessment (1:1 allocation ratio): intervention group where they will receive VR or no-intervention group. A priori, an independent administrator will prepare a computer-generated randomization schedule in random-sized permuted blocks of variable size, randomly varying from 2, 4 or 6 participants. The treatment allocation scheme will be prepared by the administrator and concealed in opaque sealed envelopes. The envelopes will only be accessible by another study coordinator who will only open them after informed consent and baseline measures have been obtained and will be responsible for administering the intervention to the participants. 

Blinding: 

 Owing to the interventional nature of the study, blinding is not possible for the participants and investigators. However, the researchers conducting the outcome assessments and data analysis will be blinded. Blinded results from the analyses (Intervention vs. No intervention group) will be presented to all authors, who will agree on two possible written interpretations before the data manager unblinds the randomization code. 

Procedure: 

 Before the procedure, the child and their parents/guardians will be explained about the detail of the study tools. They will be asked to point to the face in the scales that most accurately show how they felt during the procedure and to fill in the SAS-C. The participants in the intervention group will be taken into the room where the intervention is occurring and asked to sit in the chair. They will be accompanied by their parents/guardians. The participants will be assessed at the baseline for their socio-demographic characteristics and response to the three scales will be assessed. They will be shown the VR headset (PICO 4) and an explanation as to how it works will be given. Any questions from the child or parent/guardian will be addressed. The VR will then be placed on the child, and they will be shown a three-dimensional landscape. The needle procedure will then take place about which only the parents will be informed. After the procedure, the scales will be administered again. If the child wishes to remove the VR, the procedure will be stopped, and the VR will be immediately removed. The procedure will continue afterword without the VR and the child will be excluded from the trial. The children in the control group will undergo the same procedure as above without any intervention of VR. 

Intervention: 

 The VR headset will be placed on the child before the procedure and adjusted as per their comfort and will be removed after the procedure. 

Evaluation and Outcome Measures: 

 Primary outcomes:

 • Mean difference in score obtained in the WBS between intervention and control group 

 • Mean difference in score obtained in the CFS between intervention and control group 

 • Mean difference in score obtained in the SAS-C between intervention and control group 

 Secondary outcomes:

 • Mean difference in score obtained in the CFS before and after the intervention 

 • Mean difference in score obtained in the SAS-C before and after the intervention

 • Correlation between fear point difference in intervention

 • Correlation between anxiety point difference in intervention 

Assessment of adverse events (AE): 

 Participants will also be encouraged to promptly report any AEs, and serious AEs encountered during the trial. 

Statistical Analysis and Sample Size: 

 The sample size determination is predicted on the anticipated alteration in the primary outcome measure, i.e., the change in the pain point through WBS. A sample size of 143 participants per group is estimated to detect a mean difference of 3 points in the WBS with a statistical power of 80% at a significance level of 5%, assuming the superiority margin to be 0.05 and the standard deviation to be 0.1. Efficacy analyses will be conducted on the intention-to-treat population. Descriptive statistics will be employed to assess demographic and baseline characteristics. Baseline homogeneity will be assessed using the two-sample t-test or Mann–Whitney U test for continuous variables and the chi square test or Fisher’s exact test for categorical variables. Continuous parameters will be evaluated using analysis of covariance, with the treatment group as the effect and baseline value as the covariate. Within this framework, point estimates and 95% confidence intervals will be calculated for the least square mean changes within each treatment group, and paired t-tests will be employed for within-group comparisons. Categorical parameters will be assessed using the chi-square test or Fisher’s exact test as deemed appropriate. Multiple linear regression analysis will be carried out to determine the association of use of VR with change in the WBS, CFS and SAS-C. R2 statistics will be carried out to determine the association of intervention and control group with fear point and anxiety point differences. The percentage of participants reporting AEs will be compared using the chi-square test or Fisher’s exact test. The significance level for all statistical tests will be set at 0.05. All statistical analyses will be executed using SPSS software version 24.0 (IBM, Armonk, NY, USA) 

Ethical Approval: 

 1. Ethical approval will be taken from the Ethics Committee and informed assent will be taken from the parents/guardians. 

 2. Participants will be provided with a study information sheet as per prescribed format. 

 3. Participants will be explained that their identity will remain confidential. 

 Implications: 

 1. VR interventions will reduce the stress on children, parents, and caregivers during any kind of medical and surgical procedures. 

 2. It will help in reducing the time taken to pacify recipients of needle procedures.

 3. Such interventions might improve the acceptability of difficult procedures in resource- limited and time-limited settings.