None listed
Conditions
Brief summary
This study involves testing a digital psychosocial module on reducing caregiver's of children with Acute Lymphoblastic Leukemia (ALL)'s psychological distress and pain in children. We hypothesized that the psychosocial module is effective in reducing caregiver's posttraumatic stress, depression and anxiety, which also correlates with a reduction in children's self-rate pain score as they undergo medical procedure.
Interventions
The intervention will be a single blinded, parallel arm, clinically randomized trial of a digital psychosocial module based on the cognitive behavioural approach. The URL of the module is underway as the module is still being set up on the web. The module consists of six chapters focusing on needs identification, effective communication, managing thoughts, emotions and behaviour, stress and coping, problem solving and access to resources in Malaysia. The mode of delivery include notes for self-r
The intervention will be a single blinded, parallel arm, clinically randomized trial of a digital psychosocial module based on the cognitive behavioural approach. The URL of the module is underway as the module is still being set up on the web. The module consists of six chapters focusing on needs identification, effective communication, managing thoughts, emotions and behaviour, stress and coping, problem solving and access to resources in Malaysia. The mode of delivery include notes for self-reading and materials that can be downloaded for use. Participants will be randomly divided into one of two groups (intervention vs. control). The control group will go through usual care. At the same time, the intervention group will be given the digital psychosocial module that they can access at their convenience in span of two weeks. For clarity, the module will be completed by caregivers only. The primary researcher will conduct the recruitment, randomization and remote monitoring (participants are contacted via telephone within the first and final 48 hours of the two-week period for progress checking, queries or support) whereas the follow-up data to measure the effectiveness of the intervention will be collected by a blinded secondary researcher. Monitoring of adherence to the intervention will be done via website analytics on insights such as the number of active users and average engagement time per active user.
Sponsors
Agnes Chong Shu Sze
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Caregiver i. The person who spends a majority of their time caring for the child, often known as the primary/secondary caregiver (not limited to biological parents). ii. Literate in English or Bahasa Melayu. Child i. Children aged 4 to 12 years old, diagnosed with Acute Lymphoblastic Leukaemia who are currently in the treatment phase. The Paediatric Pain Management Guideline states that children can reliably report pain at 4 years old (MOH, 2023). ii. Scheduled to undergo painful procedures. iii. Literate in English or Bahasa Melayu. Note: The sampling criteria must be met by the pair of caregiver-child dyad.
Exclusion criteria
Caregiver i. Caregivers who have a known mental health condition and/or undergoing psychological intervention or psychiatric treatment. Child i. Children who are under palliative or hospice care. ii. Children with a known condition (eg: developmental disorder) that affects accurate reporting of pain score.
Outcome results
None listed