NCT03896165

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 30, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2020

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

March 9, 2023

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

March 25, 2019

Results QC Date

August 2, 2022

Last Update Submit

March 7, 2023

Conditions

Keywords

Complementary Health ApproachParentAdolescent

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Rate of Change in Adolescents' and Parents' Stress Response (as Measured by Hair Sample).

    Week 0, week 9

  • Rate of Change in Adolescents' and Parents' Stress Response (as Measured by Saliva Alpha Amylase).

    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.

    Week 0, Week 4, Week 9

  • Explore the Parents Confidence in Delivering Reiki Through Audio-recorded Interviews

    Week 9

  • Explore Parents' Confidence Their Ability to Help Their Adolescent Through Audio-recorded Interviews

    Week 9

Study Arms (1)

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.

Other: Reiki

Interventions

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.

Teaching Reiki

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

The Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Chronic Disease

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Results Point of Contact

Title
Assistant Professor
Organization
Ohio State University College of Nursing

Study Officials

  • Susan E Thrane, PhD, RN

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Mixed methods quasi-experimental one group design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 29, 2019

Study Start

July 30, 2019

Primary Completion

April 24, 2020

Study Completion

April 24, 2020

Last Updated

March 9, 2023

Results First Posted

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations