Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03896165 |
| Other study ID # |
2018X0079 |
| Secondary ID |
U2CNR014637 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 30, 2019 |
| Est. completion date |
April 24, 2020 |
Study information
| Verified date |
March 2023 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The proposed study addresses National Institute of Nursing Research (NINR) priorities of
advancing symptom science to "develop [and] test … novel, scalable symptom management
interventions, including complementary health approaches (CHAs), in real-world clinical
settings to improve health outcomes and quality of life" and the science of compassion to
improve palliative and end-of-life care through "developing, testing, and implementing
personalized, culturally congruent, and evidence-based palliative and hospice interventions
that best address the needs of underserved, disadvantaged, and diverse populations across the
care continuum." A long-term bonus of teaching parents to deliver Reiki is that Reiki is
highly scalable and once learned, costs nothing to use, an important potential overall cost
savings over other CHAs.
Description:
Despite advances in the assessment and treatment of symptoms, including pain in adolescents
receiving palliative care, parents still report that their children suffer. Advances in
medical science and care have led to a growing number of children living with life-limiting
chronic conditions. Out of 83 million children under the age of 19,16 an estimated 600,000 to
1,600,00017 are living with life-threatening/life-limiting conditions and over 180,000 are
considered "medically fragile." These children require intense medical and nursing care in
the home and often experience lengthy, recurrent hospital stays, accounting for about 26% of
hospital days and 41% of hospital charges. Adolescents with life-threatening/life-limiting
conditions, many of whom are developmentally delayed, experience many symptoms and have
complex co-morbidities requiring medical management.
Many of these adolescents could benefit from complementary health approaches (CHAs) such as
Reiki, a gentle light touch biofield energy therapy. Parents of adolescents receiving
palliative care also experience high levels of stress. Previous studies have shown that
empowering parents in the care of their chronically ill child help parents better cope with
challenges. Some CHAs show promise for symptom management without side effects, such as
sedation from additional medication, thereby permitting greater alertness and allowing more
interaction with family and friends. Preliminary evidence from the PIs pilot study showed
that professionally-delivered Reiki is feasible for children and adolescents receiving
palliative care at home. The majority of parents said they wished they could learn Reiki so
they might provide this relaxing therapy in the moment it was needed rather than waiting for
the next professional session. One non-experimental program found that teaching parents Reiki
was feasible and acceptable in the hospital. Parents who participated in two or more training
sessions felt more confident providing Reiki. During informal interviews, parents said they
felt good at being an active participant in their child's care and that their child
experienced increased comfort, relaxation, and decreased pain.
Parents of disabled adolescents receiving palliative care often suffer from high caregiver
burden and chronic stress leading to co-morbidities and decreased QoL. A cross-sectional
survey conducted in Europe examined stress in 818 parents caring for a child with cerebral
palsy. Results showed that 26% of mothers had very high stress. When the child had a
communication or intellectual impairment or moderate-to-severe pain, parental stress was
higher. One study examined psychological burden for 204 parents of children with serious
chronic conditions. This study found that 75% of parents reported depression, and 67% had
anxiety. The investigators are interested in exploring whether adding a skill (Reiki) aimed
at decreasing symptoms in the adolescent will result in a decrease in symptoms and chronic
stress for the parent.
