Palliative CareNCT03896165
Teaching Parents Reiki for Their Adolescents Receiving Palliative Care
A study testing Reiki in people with Palliative Care and Chronic Disease, run by Ohio State University at 2 sites in United States.
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"… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Palliative Care, Chronic Disease
- What is being tested?
- Reiki
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jul 2019to 24 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants will include adolescent-parent dyads. Dyads will be included if the
- Adolescent: (1) is 10 to 19 years old, (2) is receiving palliative care at home, (3) understands English
- Parent: (1) provides care for the adolescent most days of the week and (2) is able to read and write English at the 6th grade level.
Who cannot join
- if (1) either the adolescent or the parent are taking or have taken corticosteroids within the last 30 days (affects the hair cortisol levels), or (2) either the adolescent or the parent has less than one inch of hair.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Akron Children's Hospital
Akron, Ohio, 44308
The Ohio State University College of Nursing
Columbus, Ohio, 43210
About this study
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.
Read the detailed 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.
- Conditions
- Palliative Care, Chronic Disease
- Being tested
- Reiki
- Keywords
- Complementary Health Approach, Parent, Adolescent
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Reiki |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks
Secondary outcomes (5)
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.
Measured: Week 0, week 9
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start30 Jul 2019
- Primary completion24 Apr 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed methods quasi-experimental one group design
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Akron Children's Hospital, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Susan E Thrane, PhD, RN, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896165
- Sponsor's protocol ID
- 2018X0079
- Other IDs
- U2CNR014637
- Status last verified
- Mar 2023
- First submitted
- 25 Mar 2019
- Last updated
- 9 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Parents Reiki for Their Adolescents Receiving Palliative Care
- ClinicalTrials.gov ID
- NCT03896165
- Acronym / sponsor ID
- 2018X0079
- Conditions
- Palliative Care, Chronic Disease
- Keywords
- Complementary Health Approach, Parent, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Akron Children's Hospital, National Institute of Nursing Research (NINR)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Posted 9 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed methods quasi-experimental one group design
| Arm | Type | Receives |
|---|---|---|
| Teaching Reiki | Experimental | Other: ReikiParent-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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will include adolescent-parent dyads. Dyads will be included if the
- Adolescent: (1) is 10 to 19 years old, (2) is receiving palliative care at home, (3) understands English
- Parent: (1) provides care for the adolescent most days of the week and (2) is able to read and write English at the 6th grade level.
Key exclusion criteria (1 listed)
- if (1) either the adolescent or the parent are taking or have taken corticosteroids within the last 30 days (affects the hair cortisol levels), or (2) either the adolescent or the parent has less than one inch of hair.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReikiReiki 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. | Other | Teaching Reiki |
Primary outcome
Satisfaction of Parents Learning Reiki in the Home to Use With Their Adolescent Receiving Palliative Care.
Time frame: Four weeks
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.
5 secondary outcomes
Rate of Change in Adolescents' and Parents' Stress Response (as Measured by Hair Sample).
Time frame: Week 0, week 9
Rate of Change in Adolescents' and Parents' Stress Response (as Measured by Saliva Alpha Amylase).
Time frame: 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.
Time frame: Week 0, Week 4, Week 9
Explore the Parents Confidence in Delivering Reiki Through Audio-recorded Interviews
Time frame: Week 9
Explore Parents' Confidence Their Ability to Help Their Adolescent Through Audio-recorded Interviews
Time frame: Week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Palliative Care
Not yet recruitingObservational study
IN-TALK: Co-producing a Hospice Intimacy Support Toolkit in England
Communication About Intimacy Needs in Hospice and Palliative Care
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
Not yet recruiting
Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E Thrane, PhD, RN principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki in people with Palliative Care and Chronic Disease, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of Parents Learning Reiki in the Home to Use With Their Adolescent Receiving Palliative Care. (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.