Jaclyn F. Wood and Dr. Barbara Mandleco, Nursing Research and Scholarship
The purpose of this research project was to determine parental perceptions surrounding the involvement of their children in a clinical trial. A secondary purpose was to talk to the children and obtain their perceptions surrounding their own involvement in the clinical trial. For this ORCA funded project I analyzed interviews with the parents to find out their perceptions. In a future project (for which I will be applying for an ORCA grant) I hope to analyze interviews with the children and gain their insight into their involvement in the clinical trial.
Salt Lake City Shriners Hospital has needed and desired to have this research project done. Working with their research coordinator, Jeanne Siebert, I was able to gather a sample of five families all of which had a child with the disease Osteogenesis Imperfecta (abbreviated as O.I.). Having this disease the children are unable to build normally dense bone tissue. They develop defective connective tissue in their bones also referred to as mutant collagen. Normal collagen makes up the structure and provides the strength of the bone (Anderson, 2002), but the collagen of these children is recognized as being defective by their bodies and is destroyed or incorporated into their bony extra cellular matrix (Cole, 2002). As a result, these children have weaker, less structured bones and are more susceptible to bone fractures and bone destruction than those with normal healthy bones (O.I. Foundation, 2002).
The children of these five families were enrolled in a clinical trial at Salt Lake City’s Shriners Hospital where they were administered biphosphonate medications in hopes of increasing the density of their bones and thereby reducing their fractures. The biphosphonate medications (alendronate sodium and pomegranate disodium) have proven to decrease the breakdown of the children’s bone tissue.
Through my interviews of the parents of these children I have come to understand the stresses and benefits of being in a clinical trial. The following information discusses all of my findings. By examining the perceptions of the parents I was able to gather information pertinent to the bettering of clinical trials at Shriners Hospital.
Five families were interviewed during the course of the research project. The parents interviewed included five mothers and two fathers. The mother’s ages ranged from 32-50 years old. The father’s ages ranged from 37-43 years old. The families had from one to seven children, with the child enrolled in the clinical trial as the last born child in each family expect one (in that family the child was the first born of three). Two of the mothers were homemakers and the other three worked part time or full time. One father was a homemaker and the other worked full time. The families had an annual income of under $10,000 up to $80,000. Two families were from Idaho, two from Utah, and one from Arizona.
The five children (one from each family) enrolled in the clinical trial at Shriners Hospital ranged in age from 8-19 years old. Three were female and two male. Their grades in school ranged from 3rd grade to a high school graduate. They were all diagnosed with their condition with in one hour of birth except one female who wasn’t diagnosed until nine months of age (when the doctor noticed her sclera where blue-a sure sign of O.I.). Enrollment in the clinical trial of taking biphosphonate mediation for the children occurred as early as December 1998 and as late as February 2003. Previous to this clinical trial only one child had been enrolled in any other clinical trial. Previous treatments they took place in included rodding surgeries, closed reduction surgeries, calcium supplements, and continual oxygen supplement. The hobbies and interests of the children included reading, talking on the phone, playing on the computer, playing outdoors, spending time with pets, participating in art, and even snowboarding.
Parental perceptions of clinical trials, according to this study of five families, is very positive so long as the clinical trial is beneficial to the child. If there is any unknown side effects or possibility of detrimental outcomes parents are very wary to have their child participate. Because this clinical trial has been so successful most of the parents are open to trying other clinical trials. But, because this clinical trial has been such a great success the parents seem reluctant to even switch and try another clinical trial unless it is guaranteed to be much more beneficial than the current one. This reluctance shows that the clinical trial these parents were involved in was of great success!
The satisfaction the parents felt with the treatment and care received from Shriners Hospital was very evident in all of the interviews conducted. One mother felt it was “mind boggling” that her child could have the opportunity to participate in the study while having the expenses already paid for. She also raved about the control her child felt in the treatments since Shriners let the children direct their own care whenever possible.
The only change or desire that the parents had for the clinical study was to decrease the pain involved with it. This pain was from the I.V. that must be placed in order for the medication to be administered. They stated that their children dreaded the I.V. process and some of them had anxiety associated with it. They wished the medication could be developed into an oral form. But, besides the pain of the I.V. the satisfaction rate of the families involved in this clinical trial was high.
Upon finishing this project I feel great satisfaction and joy in being a researcher for the College of Nursing. The knowledge I gained from the research enables me to be a more educated nurse and researcher. Not only will this study benefit myself, the College of Nursing, and BYU, but also Shriners Hospital. A much more in-depth report has been developed for Shriners. Through the data analysis provided I hope the hospital will have gained the information needed to further develop future clinical trials.