Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U2CNR014637 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Akron Children's Hospital | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teaching Reiki | Experimental | Parent-adolescent pairs will be in the study for a total of nine weeks from enrollment to the follow up visit. During Week 1, the parent will receive Reiki training, a poster with suggested hand positions and a commercially-available book about Reiki in the home. During Week 2 the parent will receive a Reiki booster session with a repeat of the training and may ask questions in the home. At the end of Week 4, measures will be repeated either in person or by phone. During Week 8, measures will be repeated, another hair sample obtained and the parent will participate in a qualitative interview. The qualitative interview will be administered in person by trained Ohio State University College of Nursing study staff as part of the interview session. Interviews will be audio recorded using a hand-held audio recording device. Audio recording is voluntary and participants can choose to not have their interview recorded and still be a part of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reiki | Other | Reiki is a complementary health approach where trained providers place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. A Reiki practitioner will perform the initial teaching and instruct the parent how to perform a simple 15-minute Reiki session. Parents will complete a return demonstration using light touch with their adolescent. Parents will be asked to complete a minimum of 15 minutes of Reiki with their adolescent at least five days per week for the four-week intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of Parents Learning Reiki in the Home to Use With Their Adolescent Receiving Palliative Care. | Satisfaction will be examined by computing the proportion of approached subjects who enroll in the study, the proportion of subjects who complete Reiki training, and the proportion of enrolled subjects who complete data collection. | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Change in Adolescents' and Parents' Stress Response (as Measured by Hair Sample). | Explore the adolescents' and parents' stress response. We will measure hair cortisol at the beginning and again at week 9. | Week 0, week 9 |
| Rate of Change in Adolescents' and Parents' Stress Response (as Measured by Saliva Alpha Amylase). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan E Thrane, PhD, RN | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akron Children's Hospital | Akron | Ohio | 44308 | United States | ||
| The Ohio State University College of Nursing |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Teaching Reiki | Parent-adolescent pairs will be in the study for a total of nine weeks from enrollment to the follow up visit. During Week 1, the parent will receive Reiki training, a poster with suggested hand positions and a commercially-available book about Reiki in the home. During Week 2 the parent will receive a Reiki booster session with a repeat of the training and may ask questions in the home. At the end of Week 4, measures will be repeated either in person or by phone. During Week 8, measures will be repeated, another hair sample obtained and the parent will participate in a qualitative interview. The qualitative interview will be administered in person by trained Ohio State University College of Nursing study staff as part of the interview session. Interviews will be audio recorded using a hand-held audio recording device. Audio recording is voluntary and participants can choose to not have their interview recorded. Reiki: Reiki is a complementary health approach where trained providers place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. A Reiki Master will perform the initial teaching and instruct the parent how to perform a 15-minute Reiki session. Parents will complete a return demonstration using light touch with their adolescent. Parents will be asked to complete a minimum of 15 minutes of Reiki with their adolescent at least five days per week for the four-week intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Ten parent-adolescent pairs (20 participants total)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teaching Reiki | Parent-adolescent pairs will be in the study for a total of 9 weeks from enrollment to the follow up. Week 1, the parent will receive Reiki training, a poster with suggested hand positions and a commercially-available book about Reiki in the home. Week 2 the parent will receive a Reiki booster session with a repeat of the training and asking questions in the home. At the end of Week 4, measures will be repeated either in person or by phone. Week 8, measures will be repeated, another hair sample obtained and the parent will participate in a qualitative interview. The qualitative interview will be administered in person by trained Ohio State University College of Nursing study staff. Interviews will be audio recorded using a hand-held audio recording device. Audio recording is voluntary and participants can choose to not have their interview recorded and still be a part of the study. Reiki: Reiki is a complementary health approach where trained providers place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. A Reiki practitioner will perform the initial teaching and instruct the parent how to perform a simple 15-minute Reiki session. Parents will complete a return demonstration using light touch with their adolescent. Parents will be asked to complete a minimum of 15 minutes of Reiki with their adolescent at least five days per week for the four-week intervention period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 10 parent-adolescent pairs (10 parents and 10 adolescents for a total of 20 participants) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Satisfaction of Parents Learning Reiki in the Home to Use With Their Adolescent Receiving Palliative Care. | Satisfaction will be examined by computing the proportion of approached subjects who enroll in the study, the proportion of subjects who complete Reiki training, and the proportion of enrolled subjects who complete data collection. | Number of enrolled participants who completed Reiki training activities | Posted | Count of Participants | Participants | Four weeks |
|
Nine weeks.
All adverse event information collected concurs with the clinicaltrials.gov definitions
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Teaching Reiki | Parent-adolescent pairs will be in the study for a total of nine weeks from enrollment to the follow up visit. Week 1, the parent will receive Reiki training, a poster with suggested hand positions and a commercially-available book about Reiki in the home. Week 2 the parent will receive a Reiki booster session with a repeat of the training and may ask questions in the home. At the end of Week 4, measures will be repeated either in person or by phone. Week 8, measures will be repeated, another hair sample obtained and the parent will participate in a qualitative interview. The qualitative interview will be administered in person or over Zoom by trained Ohio State University College of Nursing study staff. Interviews will be audio recorded using a hand-held audio recording device. Audio recording is voluntary and participants can choose to not have their interview recorded and still be a part of the study. Reiki: Reiki is a complementary health approach where trained providers place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. A Reiki Master will perform the initial teaching and instruct the parent how to perform a 15-minute Reiki session. Parents will complete a return demonstration using light touch with their adolescent. Parents were asked to complete a minimum of 15 minutes of Reiki with their adolescent at least five days per week for the 4-week intervention period. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor | Ohio State University College of Nursing | 614-292-5684 | thrane.2@osu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2019 | Aug 2, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019124 | Therapeutic Touch |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
Not provided
Not provided
Mixed methods quasi-experimental one group design
Not provided
Not provided
Not provided
Not provided
|
We will also measure saliva alpha amylase twice per week for 4 weeks. |
| Week 1, week 2, week 3, week 4 |
| Change in Adolescents' and Parents' Symptom Profile as Measured by Patient Reported Outcome Measurement Information System (PROMIS) Symptom Questionnaire. | Explore the adolescents' and parents' symptom profile (as measured by changes in physical function, anxiety, depression, fatigue, sleep, social roles, and pain level). | Week 0, Week 4, Week 9 |
| Explore the Parents Confidence in Delivering Reiki Through Audio-recorded Interviews | Explore parents' confidence in delivering Reiki to their adolescent after completing Reiki training and practicing providing Reiki to their adolescent. | Week 9 |
| Explore Parents' Confidence Their Ability to Help Their Adolescent Through Audio-recorded Interviews | Explore parents' confidence their ability to help their adolescent after completing Reiki training and practicing providing Reiki to their adolescent. | Week 9 |
| Columbus |
| Ohio |
| 43210 |
| United States |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Rate of Change in Adolescents' and Parents' Stress Response (as Measured by Hair Sample). | Explore the adolescents' and parents' stress response. We will measure hair cortisol at the beginning and again at week 9. | Data was unable to be collected | Posted | Week 0, week 9 |
|
|
| Secondary | Rate of Change in Adolescents' and Parents' Stress Response (as Measured by Saliva Alpha Amylase). | We will also measure saliva alpha amylase twice per week for 4 weeks. | Data was unable to be collected | Posted | Week 1, week 2, week 3, week 4 |
|
|
| Secondary | Change in Adolescents' and Parents' Symptom Profile as Measured by Patient Reported Outcome Measurement Information System (PROMIS) Symptom Questionnaire. | Explore the adolescents' and parents' symptom profile (as measured by changes in physical function, anxiety, depression, fatigue, sleep, social roles, and pain level). | Data was unable to be collected | Posted | Week 0, Week 4, Week 9 |
|
|
| Secondary | Explore the Parents Confidence in Delivering Reiki Through Audio-recorded Interviews | Explore parents' confidence in delivering Reiki to their adolescent after completing Reiki training and practicing providing Reiki to their adolescent. | Data was unable to be collected | Posted | Week 9 |
|
|
| Secondary | Explore Parents' Confidence Their Ability to Help Their Adolescent Through Audio-recorded Interviews | Explore parents' confidence their ability to help their adolescent after completing Reiki training and practicing providing Reiki to their adolescent. | Data was unable to be collected | Posted | Week 9 |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
Not provided
Not provided
Not provided